USP<797> & USP<800> Resources & Compliance

Leading Providers of USP<797> Consulting, USP<800> Solutions, USP<797> Resources, USP Compliance, USP<800> Services

USP<797> & USP<800> Resources & Compliance Booth #14735
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Request More Information Visit the Helmer Scientific Website

Helping you provide the highest standard of patient care with storage you can trust!

When it comes to your refrigerator and USP <800>, Helmer is here to help. Cold storage is an important part of keeping your hazardous drugs safe and stable. Improper cold storage can lead to unnecessary waste, financial loss, lack of compliance, and pose major safety concerns. As we get closer to July of 2018, facilities will continue to adapt their hazardous drug room to meet USP <800> compliance. Helmer upright, undercounter, and countertop refrigerators are safe and effective cold storage solutions for your sensitive and expensive hazardous drugs.

Undercounter Refrigerators and Freezers

Undercounter refrigerators and freezers may be used free-standing, stacked, or under a counter providing flexibility for each facility with high-performance temperature stability for critical product storage.

  • Available in 5 cu ft and 4 cu ft ADA models
  • Superior chamber uniformity and quick recovery with heavy-duty, air-cooled, forced-air refrigeration system
  • Recessed floor contains spills for easy clean-up
  • Field-reversible door
  • Bacteria-resistant powder coated exterior and interior provides additional security
  • Reduced humidity levels create dry storage environment

Upright Refrigerators and Freezers

Pharmacy refrigerators and freezers are designed specifically for the high demands of healthcare. Built-in monitoring systems provide continuous monitoring, real-time alarm notification, and status notification for worry-free storage, allowing your staff to focus on the critical functions of their job.

  • Models available from 11 cu ft to 56 cu ft
  • Superior chamber uniformity and quick recovery with heavy-duty, air-cooled, forced-air refrigeration system
  • Adjustable LED lighting provides energy-efficient illumination
  • ADA compliant door handles
  • Recessed floor contains spills for easy clean-up
  • Bacteria-resistant powder coated exterior and interior provides additional security
  • Reduced humidity levels create dry storage environment

Pass-thru Refrigerators
Pass-thru refrigerators create a boundary between USP <797> clean rooms and regular facility environments. Pass-thru refrigerators play a major role in enhancing clean room workflows, minimizing clean room foot traffic, and lowering PPE costs.

  • Models available from 26.5 cu ft to 58 cu ft
  • Superior chamber uniformity and quick recovery with heavy-duty, air-cooled, forced-air refrigeration system
  • Adjustable LED lighting provides energy- efficient illumination
  • ADA compliant door handles
  • Recessed floor contains spills for easy clean-up
  • Bacteria-resistant powder coated exterior and interior provides additional security
  • Reduced humidity levels create dry storage environment
  • Drawer mid-stop catch ensures proper closure to maximize airflow, maintain temperature uniformity, and protect glass doors from slide throughs

Ultra-Low Freezers
How It’s Made Matters. Reliable storage at -80°C.

  • Models available from 16 cu ft to 26 cu ft
  • Heat Barrier System™ provides superior temperature uniformity and minimizes frost
  • Guardian Plus® Access Control is included standard on all units
  • Optimum oil management, through an exclusive refrigeration design, provides greater reliability
  • Diagnostic data and graphs enable faster troubleshooting, reducing downtime
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USP<797> & USP<800> Resources & Compliance Booth #16126
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Request More Information Visit the Comprehensive Pharmacy Services CPS Website

Compliance Consulting Solutions by CPS


Delivering Across Three Fronts:

Assessments
Regulatory compliance assessment includes regulatory requirements, professional standards of practice, accreditation standards, policies & procedures, and indicators representing high performing pharmacy operations.

Action Plans
Corrective action plan identifies resources, templates and best practices to improve probability of successful implementation and ongoing compliance.

Expert Support
Guidance by pharmacy practice regulatory specialist to advice, clarify, address barriers, promote and support continued improvement and compliance.

CPS Compliance: Sterile Compounding

Set up your pharmacy for success.

From pharmacy set up to success, we are the partner that can help you with USP 797 and 800. We have expertise in all aspects from where your sterile compounding room should be to how it should be set up and managed. Should you undergo an audit, we can be your pharmacy point person and guide you through it.
CSP is the USP 797 & 800 expert and the trusted partner you need to set your pharmacy up for success.

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USP<797> & USP<800> Resources & Compliance Booth #16114
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Request More Information Visit the International Medical Industries Website

International Medical Industries

Innovative Sterile Products for Compounding Pharmacies.

Since 1969, IMI has worked closely with hospital pharmacies and outsource compounders to create innovative products to address very specialized needs. We offer a complete line of sterile caps, connectors, adapters and more. IMI has made pharmacy compounding products our sole focus. As a result, our customers experience the quality service and value that only a specialized partner can provide. All products are made in the U.S.A. at our FDA licensed facility under strict quality and regulatory controls.

The IMI Product Families Include:

Prep-Lock™ Tamper Evident Caps for I.V. Syringes and Oral Dispensers

The Prep-Lock product family is engineered to protect Compounded Sterile Preparations (CSP’s) and Oral Preparations. The likelihood of tampering or compromise is at its greatest during transportation when the product leaves the custody of the pharmacist. IMI Tamper Evident Caps help maintain product integrity and greatly enhancing USP <797> compliance. Tampering is immediately evident when the outer sleeve is broken or missing. Unused syringes with Tamper Evident Caps intact can be returned to inventory with confidence.

Prep-Seal™ Sterile Caps and Plugs

Our Prep-Seal products are designed for any compounded product or compounding procedure that requires capping or intermittent capping. Common uses include the capping of syringes or as a protective cap for access ports on medical devices such as stopcocks or IV set when not in use. They are offered in both luer-lock and luer-slip configurations.

Prep-Fill™ Sterile Connectors (Fluid Transfer/Mixing)

The Prep-Fill family of products facilitates the transfer of fluids. Common uses include the transfer or mixing of fluids between syringes or connecting various IV sets. They are offered in both luer-lock and luer-slip configurations.

RX-Vent™ Filtered Vent Needles

The RX-Vent family of products offers unsurpassed safety and efficiency to the pharmacist. The Chemo-Vent is used for reconstituting and withdrawing cytotoxic anti-neoplastic agents. It prevents blowback of chemotherapeutic and cytotoxic drugs during fill procedures. The Filtered Venting Needle is used for the sterile venting of drug vials.

RX-Tract™ Sterile Fluid Extraction Needles

The RX-Tract family of products offers the clinician the ability to withdraw fluids from all types of mini vials and deep containers. They are available in both sharp and blunt tip configurations and multiple lengths.

Sharp Cannula: The sharp cannula is used to draw liquid for reconstruction or to pre-fill syringes prior to administration.

Blunt Cannula: The large-bore, blunt cannula allows rapid transfer of blood with minimum hemolysis. The blunt end prevents accidental needle sticks.

FREE Sterile Samples are available for our entire product line. See why IMI has become the brand pharmacists’ trust for innovative sterile products.

Syringe Graphic
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USP<797> & USP<800> Resources & Compliance Booth #14736
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Request More Information Visit the Prudential Cleanroom Services Website

USP <797> & <800> Personal Protective Equipment

Personal protective equipment is the first line of defense against exposure to Hazardous Drugs and the most cost effective means to protect employees. Prudential Cleanroom Services' garments also product the product from the employees. Humans are one of the largest contamination contributors to any cleanroom environment unless they are gowned correctly.


CLEANROOM GARMENT SYSTEM FEATURES

  • Hood
  • Goggles
  • Coverall
  • Boots
  • Facemask
  • Sleeve Cover
  • Frock
  • Inner Wear Shirt - Long Sleeve
  • Inner Wear Shirt - Short Sleeve
  • Pant



PCS VALIDATED REUSABLE MOP PROGRAM
Why purchase mop heads and dispose of them when you can reuse them?

  • Validated Reusable Mop Head
  • Validated Reusable



All Prudential Cleanroom Services products are Validated SAL 10-6 for our Aseptic customers.

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USP<797> & USP<800> Resources & Compliance Booth #16122
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Request More Information Visit the Labconco Website

Labconco

Labconco’s mission is to enhance global scientific discovery by providing exceptional equipment and service.

It’s our goal to protect your laboratory environment, the integrity of your work, and you.

Serving the scientific community since 1925, we manufacture laboratory equipment, specializing in ventilation products such as balance enclosures, biological safety cabinets, and clean benches. Our RXPert Balance Systems meet USP <800> requirements for non-sterile hazardous compounding. Our Purifier Logic+ and Axiom Biosafety Cabinets are NSF listed. All Labconco enclosures are built to maximize containment, comfort, and convenience.

Our equipment is designed and manufactured in Kansas City, MO and Fort Scott, KS. Our ISO 9001 certification is a measure of our commitment to quality and consistency. We are committed to customer satisfaction and provide award-winning service before, during, and after purchase.

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USP<797> & USP<800> Resources & Compliance Booth #16119
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Request More Information Visit the ISO-MED Website

ISO-MED

ISOlutions for your Cleanrooms and Medical Supplies!

California-based corporation was formed to supply quality products for the biotechnology and healthcare industries in the United States.

As a manufacturer, a manufacture representative, and a wholesaler, we offer an extensive array of products, including:

  • Medical and Laboratory Plastic Wares
  • Clean Room Supplies (USP 797 and USP 800 products)
  • Hospital Disposables
  • And More..

ISO-MED provides an unparalleled level of convenience for our customers. As a result, we offer a unique opportunity to provide top-quality products, responsive customer service, and highly cost-effective purchasing options for all our customers.

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USP<797> & USP<800> Resources & Compliance Booth #16111
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Request More Information Visit the Associates of Cape Cod Inc Website

Associates of Cape Cod Inc

Associates of Cape Cod, Inc. (ACC), is one of the world's largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1-3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service, in our industry to enhance the productivity and efficiency of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA Inspected and DEA Licensed and our Beacon Diagnostics ® laboratory is CLIA certified.

LAL Products

ACC is one of the world's largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1-3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products, and medical devices. Our Customer Service, Technical Service, and Contract Testing teams are ready to assist you with all aspects of endotoxin and glucan testing.

LAL Accessory Products

Pyroclear® Accessory Products
Pyroclear Pyroclear® brand accessory products are the first products in the industry that are certified to be free of interfering endotoxin and (1-3)-ß-D-glucan contamination. Pyroclear brand certified products include depyrogenated test tubes, 96-well microplates, pipette tips and LAL Reagent water. These products are designed to reduce Out of Specification (OOS) investigations due to contaminated accessories.

Instrumentation

ACC is proud to offer a variety of instrumentation to support all your testing needs. Instruments like our Pyros Kinetix® incubating kinetic tube reader which offers the highest turbidimetric assay sensitivity in the industry. Bridge the gap between the affordability of filter-based readers and flexibility of monochromator-based systems with our VersaMax­™ microplate reader.

LAL Research Products

ACC offers a complete suite of reliable, easy to use research products. Developed for research purposes only, ACC's Research Products are designed to improve pyrogen testing while offering our high standard of effectiveness.

Instrumentation Software

Precise, easy-to-interpret data is an essential part of kinetic endotoxin detection programs. ACC offers three software packages designed to improve the efficiency and the compliance of your testing program all featuring 21 CFR Part 11 compliance, dynamic reporting options and increased data security.

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Associates of Cape Cod, Inc.
LAL Products
LAL Accessories
Software
ACCI Services
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USP<797> & USP<800> Resources & Compliance Booth #11621
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Request More Information Visit the Texwipe Website

Texwipe

Texwipe is the global leader in contamination control and critical cleaning supplies and products.

Headquartered in Kernersville, North Carolina, Texwipe supports global customers with sales offices throughout North America, Europe and Asia. Manufacturing centers located in North Carolina, the Philippines and China provide the highest levels of quality and manufacturing technology.

With over 50 years of experience in the contamination control industry, Texwipe offers contamination control products, technical resources and support, process audits, hands-on training seminars, posters and application specific training on how to achieve contamination control in your critical and controlled environments.

Texwipe's broad product line includes a complete array of sterile and non-sterile wipers, swabs, mops, cleaning solutions, disinfectants and stationery for use in cleanroom and controlled environments.

Products include:

  • Vectra®` ultraclean sealed-border wipers, dry and pre-wetted
  • Vectra® Alpha® 10 LT, low titanium dioxide, sealed border wiper
  • Vertex® wipers, sterile and non-sterile, dry and pre-wetted options
  • AlphaSat®, QuanSat™ , QuanSat™ LT, PolySat®, TechniSat® pre-wetted wipers
  • Sterile AlphaSat®, PolySat®, TechniSat® pre-wetted wipers
  • TexQ®,TexP™ ,TexCide™ ,TexTab™ , Sterile IPA and Denatured Ethanol cleaning and disinfecting solutions
  • CleanTips®, Cleanfoam®, and Low TOC Alpha® swabs engineered for cleanliness and consistency
  • Transplex® ESD-safe swabs
  • TexWrite® cleanroom stationery
  • KOGO ™ cleanroom adhesive tapes

Texwipe also develops custom products to address specific customer needs.

Texwipe is committed to technology, innovation, and service excellence to provide the most consistent and highest quality products. All Texwipe products are supported by the most advanced testing and quality control standards in the industry.

We are working with the leaders in technology-driven industries to apply our expertise in ever expanding ways. If you are looking for the best in the business, contact us today by using the link below.

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USP<797> & USP<800> Resources & Compliance Booth #16123
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Request More Information Visit the Contec Inc Website

Contec Inc

Advanced cleaning technology for healthcare.

Contec Healthcare offers many products for cleaning in critical areas where USP <797> and USP <800> compliance is required. Our wipes, disinfectants, sterile alcohol, non-shedding mops, gloves and garments are used in pharmacies, hospitals, and other critical medical environments to clean, disinfect and decontaminate. Most of our products, including sterile IPA and wipes, are made in the USA in our ISO 9001: 2008 registered cleanroom facilities. Let Contec’s 26+ years of experience provide solutions for all of your sterile compounding and hazardous drug decontamination challenges.

Why choose Contec?

Our experienced R&D and Technical Services teams understand the challenges of cleaning and disinfecting critical and controlled environments in a variety of complex industries. We are bringing that wealth of knowledge to the pharmaceutical and healthcare environments. Contec provides a full line of cleanroom products enabling compounders to meet the ever increasing demands for cleaner, safer pharmacies. Our products are used in many medical environments to clean and decontaminate barrier isolators, laminar air flow hoods, cabinets, tables, ceilings, walls and floors.
In the pharmacy, we understand the parameters of USP Chapter <797> and <800> regulations as well as ISO 14644 and will help your team meet these requirements. Whether you are cleaning your pharmacy’s primary engineering controls or decontaminating surface exposure to hazardous drugs, Contec offers industry-leading product solutions.

Our Products

  • Sterile Alcohol
  • Peridox® RTU Sporicidal Disinfectant & Cleaner
  • Hazardous Drug Decontamination
  • Isolator Cleaning Tools
  • Sterile Presaturated Wipes
  • Sterile Cleanroom Wipes
  • Advanced Mopping & Wall Washing Systems
  • Cleanroom Compatible Garments & Gloves

We invite you to work with our specialists to improve your cleaning process. We will assist you in selecting the Contec tools that best fit your applications. But more importantly we will assist you in designing the correct procedures that will improve your processes. To set up a free assessment and trial, contact us today.

To learn more about Contec Healthcare or to request a product trial, call +1-864.503.8333 or email us through the Request Information link below.

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Contec, Inc.
Contec, Inc.
Contec, Inc.
Contec, Inc.
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USP<797> & USP<800> Resources & Compliance Booth #16116
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Request More Information Visit the IVQA Website

Helping Medical Professionals Exceed Their Regulatory and Performance Goals

Media Fill Test Kits

IVQA Media Fill Test Kits will provide you the tools to comply with USP Chapter 797 Media Fill Test Procedure Standards on aseptic manipulation skills, including representative sterile microbial culture transfer and fill challenges. Our test kits are designed to assess correct technique and effective environmental control for the preparation of compounded sterile products.

New Packaging
After one year of researching and designing a package with the pharmacist in mind, IVQA is proud to launch our new, slim packaging designed for easy storage and usage in sterile environments.

IVQA provides three different kits to be used as part of quality assurance practices in the preparation of low-risk, medium-risk, and high-risk level compounded sterile preparations:

1. Low-Risk Media Fill Test Kit

2. Medium-Risk Media Fill Test Kit

3. High-Risk Media Fill Test Kit

Features:

  • Our test media contains Tryptic Soy Broth, which helps detect evidence of a wide variety of microorganisms, especially common aerobic and facultative anaerobic bacteria.
  • IVQA Media Test Kits are packaged to minimize space needs and limit foreign materials introduced into your IV preparation areas.
  • Log Sheets are included as a download to document that all appropriate personnel are trained and have successfully passed the needed media-fill test procedures.

For more information, or to view our product specifications and instructional videos, click the link above to visit our website.






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USP<797> & USP<800> Resources & Compliance Booth #9100
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Request More Information Visit the PCCA Website

Professional Compounding Centers of America (PCCA) provides independent pharmacists with a complete support system for compounding unique dosage forms. Owned and operated principally by pharmacists -- PCCA provides all of the bulk pharmaceuticals, equipment, devices, flavors, American Council on Pharmaceutical Education (ACPE)-accredited training classes and seminars, marketing support and technical consulting assistance needed to help pharmacists build successful compounding practices. Founded in 1981, PCCA today has more than 3,000 pharmacist members located throughout the United States, Canada, Australia, Europe, and New Zealand.

PCCA provides ACPE-accredited Primary and Aseptic Compounding courses in its in-house training laboratories. These hands-on courses provide pharmacists and their pharmacy technicians with a forum for learning the latest innovations in compounding unique dosage forms. In addition, the curriculum includes discussion of quality and safety procedures; legal issues and marketing technique.

PCCA's ACPE-accredited Continuing Education Programs provide pharmacists with ongoing opportunities to obtain the latest and greatest in compounding technique and effective methods of building patient and practitioner relationships. These programs also provide invaluable networking sessions where colleagues share what has worked well for their compounding practices and emphasize the critical importance of the triad relationship -- the patient, physician and pharmacist.

On average, PCCA's M. George Webber, Ph.D. Consulting Department answers more than 500 calls a day, providing members with comprehensive technical support. Named in honor of a PCCA founder, the Department is staffed with 21 professionals from full-time registered pharmacists to experienced pharmaceutical chemists.

PCCA works with several colleges of pharmacy to help design contemporary or advanced compounding courses. Throughout the year, PCCA also works with pharmacy associations to provide continuing education programs. In addition, the PCCA Institute is partnering with colleges of pharmacy and other accredited education providers, using the Internet to create basic pharmaceutical science courses which can be accessed by a pharmacy student at any venue on a 24 hours, 7 days a week schedule.

cGMP Independent Pharmacies powder Hospitals Universities Hospices Pharmaceutical Colleges Compound Assist Unguator HIPAA compliant JCAHO compliant JAHCO compliance patient safety companies suppliers Medisca, PCCA, Spectrum, Hawkins, ARL, Healthcare Logistics dosing,training,equipment, training bases oils capsules flavors colors devices training bases oils capsules flavors colors devices training
PCCA- Pharmacy Compounding Supplies
PCCA Compounding
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USP<797> & USP<800> Resources & Compliance Booth #14736
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Request More Information Visit the Cleanroom Connection Website

Cleanroom Connection

Your One-Stop Pharmacy Cleanroom Supplier

Cleanroom Connection is a one-stop cleanroom supplier for non-sterile and sterile compounding pharmacies, pharmaceutical manufacturers, and healthcare facilities. We stock products that comply with USP 797, USP 795, 800 and cGMP. Our pharmacy cleanroom trained staff are knowledgeable to assist you with understanding protocols and selecting supplies to comply. Our veteran compounding pharmacist consultants use their 35+ years of experience to offer personal service and customized solutions for pharmaceutical compounding and manufacturing applications as well as hospital pharmacies.

This supplier's close relationships with the nation’s leading cleanroom product manufacturers makes it possible to gain special pricing agreements that are passed along to customers. Cleanroom Connection offers wholesale prices to all its customers as well as special pricing agreements and volume pricing contracts. Take advantage of our lowest price guarantee.

Our most popular cleanroom supplies and apparel include :

  • Cleanroom Wipes
  • Sterile Cleanroom Coveralls, Frocks, Lab Coats & Hoods
  • Mops and Cleaning Tools
  • Face Masks & Veils
  • Sterile and Non-Sterile Gloves
  • Sticky Floor Mats
  • Sterile Isopropyl, Disinfectants and Sporicidal Cleaners
  • Cleanroom Skin Care Products
  • Sterile Cleanroom Goggles
  • Chemotherapy Apparel
  • Cleanroom Paper and Pens
  • Lint Free Swabs
  • Media Fill Test Kits For Low, Medium & High Risk Compounding
  • Contact Plates & Media
  • Endotoxin Challenge Kits
  • Sterilization Supplies Including Indicators, Wraps & Pouches
  • Tacky Roller Mops
  • Validated Temperature Shipping Containers
  • Cleanroom Bags and Sterile Bags
  • Waterless Alcohol Based Surgical Hand Scrub With Persistent Activity
  • Cleanroom Furniture, Tables, Gowning Benches, Shelves & More
  • Infusion Supplies
  • Compounding Supplies
  • Sharps Disposal Containers

Cleanroom Connection offers cleanroom products from the below manufacturers :

  • DuPont
  • Kimberly Clark
  • KimTech
  • Criti Clean
  • BioClean
  • Acute Care
  • CT International
  • QRP
  • TechNiGlove
  • Ansell
  • Decon Labs
  • Veltek Associates
  • Hardy Diagnostics
  • Covidien
  • Texwipe
  • Micronova
  • SPS Medical
  • Associates of Cape Cod
  • TrueCare
  • Contec
  • Micronova

To setup an account or to get pricing, simply call us toll free at 800.616.5319

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USP<797> & USP<800> Resources & Compliance Booth #16118
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Request More Information Visit the Wolf Medical Supply Website

Wolf Medical Supply

As a full-line, national distributor, Wolf Medical Supply, Inc. is distinguished within the industry by providing our customers with unbeatable value and superior customer service. In addition to our full inventory from the nation’s largest manufacturers, we offer our customers an exclusive line of Wolf-Pak® items that lends a cost effective and quality assured alternative to other products on the market. With Wolf Medical Supply as your national distributor, you will always receive friendly, knowledgeable service and personalized attention to your purchasing needs.

Wolf Medical Supply, Inc. maintains established relationships with the industry’s leading manufacturers. With our partners, we work to provide you with the best values and most reliable inventory in the industry.

Bard Access • Baxter Healthcare • Becton Dickinson • CareFusion • Energizer • Halyard Health • ICU Medical • Medegen • RMS Medical Products • Smiths Medical • Stericycle • Tidi Products • Wolf-Pak®

Wolf-Pak®

Along with access to any product on the market, our superior quality, manufacturer direct Wolf-Pak® products are in stock for immediate shipment at unbeatable prices.

Wolf Medical Supply, Inc. is affiliated with various national group purchasing organizations. In addition, we write new contracts and honor existing contracts for various product lines. With Wolf Medical Supply as your partner, you will experience low contract pricing every time you order.

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USP<797> & USP<800> Resources & Compliance Booth #14735
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Request More Information Visit the CleanAir Solutions Website

Who do the leaders of the Pharmaceutical industry trust for cleanroom construction services and high quality cleanroom products? CleanAir Solutions, Inc!

CleanAir Solutions, Inc. (CAS) was established to fill a void in the cleanroom industry by providing technical assistance to end-users and contractors for the design and implementation of cleanrooms and related products. Overall, our company can be characterized as specialists in cleanroom technology!

Modular Hardwall Cleanroom Design and Installation

CleanAir Solutions, Inc. specializes in selecting air filtration and clean room systems and supplies best suited for your cleanroom manufacturing application. Cleanroom design is perhaps the most important factor in protecting your critical product from contamination. Choosing the right type of Modular Hardwall Cleanroom or Modular Softwall Cleanroom is the first step in this process.

Built to meet your specific cleanroom application needs, your clean room design options may include the following:

  • Modular Hardwall Cleanroom Design and Equipment
    • Our CAS USP-797 cleanrooms are guaranteed to meet USP-797 Compliance.
  • Modular Hardwall Cleanroom Specialists
  • Modular Hardwall Cleanroom Wall Systems
  • Modular Hardwall Cleanroom Doors

Also offering cleanroom equipment such as:

  • Air Showers
  • Hoods
  • Isolation Systems
  • Transport Carts
  • Cleanroom Telephones

Please contact one of our cleanroom specialists to request a quote on any of our modular hardwall or softwall cleanroom designs and equipment. Click below to fill out our request form.

CleanAir Solutions, modular cleanrooms, ACT, USP <797>, pharmacy compounding, CAS 797 , USP 800, USP <800>

Cleanroom
Compounding
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USP<797> & USP<800> Resources & Compliance Booth #16124
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Request More Information Visit the LP3 Network Website

A Global Leader in Continuing Healthcare Education

LP3 Network was founded to provide the healthcare community with exceptional programs in continuing education. At LP3 Network, we believe in raising the standards of healthcare through quality education and training. Our team of experts develop innovative and high-quality programs to provide you with the knowledge and tools needed to succeed!

Our mission is to provide you with a platform of educational programs that will have a positive impact on your professional development within the healthcare industry.

  • Education is the foundation of our business;
  • We strive to empower the healthcare community through best practices;
  • At LP3 Network, we are committed to providing you with knowledge and expertise;
  • We believe in providing you with options – choose from our wide range of courses and training activities.

LP3 Network recognizes the need to provide today’s healthcare professionals with a unique experience in continuing education, while maintaining an emphasis on quality and integrity.

Activity Portfolio

The combined efforts of LP3 Network and the University of Florida College of Pharmacy allow us to offer the finest in accredited continued healthcare education. We have prepared a number of high-quality activities that will enhance your professional knowledge. Visit our website to view detailed descriptions for all of our available activities. Our current available courses are:

  • Advanced Non-Sterile Compounding
  • Business Ready: Marketing & Sales for the Successful Compounding Pharmacist
  • Essential Elements of Compounded Sterile Preparations
  • Essential Elements of Hazardous Drug Compounding
  • Essential Elements of Prescription Analgesic Compounding
  • Essential Elements of Prescription Hormone Compounding
  • Preparing for a State Board of Pharmacy Compounding Practice Inspection
  • The Science of Pharmaceutical Compounding®: Non-Sterile Training
  • The Science of Pharmaceutical Compounding: Technician Training
  • Self-Directed Learning Modules* (non-accredited)

Our team of facilitators and contributors consists of some of the foremost experts in their respective fields. Our specialists are dedicated to helping you gain the knowledge and experience required to advance your career.

Our Accreditor

Since our inception, LP3 Network has pursued a dream of developing a comprehensive portfolio of continuing education programs for the healthcare industry. With these goals in tow, the company developed a strong relationship with the University of Florida College of Pharmacy. This well-respected institution is the accreditor for all of LP3 Network’s live training activities.

The established relationship with the University of Florida College of Pharmacy allows LP3 Network to offer those seeking further healthcare education with the finest in continuous professional development. All of LP3 Network’s live training activities are accredited by the University of Florida College of Pharmacy and we pride ourselves on the quality of these activities and the competency they bring to all of our clients.


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USP<797> & USP<800> Resources & Compliance Booth #16121
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Request More Information Visit the Simplex Isolation Systems Website

Simplex Isolation Systems

USP 800 Compliant Cleanroom Systems

Achieve USP 800 compliance and provide your personnel a safer environment for handling hazardous drug compounds with Simplex’s modular, expandable and high-performing cleanroom systems. With over 35 years of success in the design and manufacture of custom cleanrooms, our process includes working closely with our customers to identify any specific requirements and cleanroom classifications to design a custom enclosure with efficiency, compliance and scalability in mind.

Our cleanrooms are engineered with easy-to-clean internal features that can withstand various cleaning processes in accordance with USP 800 compliance. Simplex wall systems are manufactured with a near-flush surface between the frame and insert panel, eliminating any hidden spaces where contaminants can hide and cause problems inside the clean environment. Simplex offers modular cleanroom components that can be included to maintain and improve the integrity of the environment, including fan filter units, custom door designs and electrical outfitting.

Key Features & Benefits:

  • Designed to meet the requirements of USP 797 and USP 800
  • Interior construction designed for easy cleaning
  • Suitable for ISO 8 (Class 100,000) to ISO 4 (Class 10) cleanroom applications
  • Available as single-pass, re-circulating design with air-chase walls and ceiling plenum or as a hardwall partition for existing sterile environments
  • Available with integrated self-supporting ceiling modules, factory-assembled for fast and simple construction
  • 2” x 2” extrusion frame comes in a clear anodized aluminum or powder coated finish and can accommodate insert panels from 1/8” to 3/8”
  • Insert panels available in ABS, acrylic, polycarbonate, aluminum or glass
  • Ships as an easy-to-build pre-assembled turnkey room

Allow Simplex to assist with your next USP 800 cleanroom project to ensure a custom enclosure that allows for the safe compounding of hazardous drugs in your facility in accordance with USP 800 regulations.

isolation, cleanrooms, strip doors, usp 797, usp 800, ISO Class, critical environments




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USP<797> & USP<800> Resources & Compliance Booth #11627
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Request More Information Visit the Containment Technologies Group Website

Established. Committed Full Service. Innovative Provider.

We are the manufacturers of the MIC Family of Isolators, which include the MIC Single, MIC Dual, MIC 797P and the MIC-EDU Systems. All of our products are manufactured in central Indiana. The MIC was designed by engineers with hazardous containment and aseptic expertise. Our engineering department is recognized throughout the world for their work with parenteral products and hazardous containment.

The MIC product line is currently implemented in nearly every state in the country as well as in over a dozen countries overseas. We are quite proud of our globally dispersed, very satisfied, and extremely loyal client base. Containment Technologies Group, Inc. - Where our goal is Protecting The Provider, The Patient, And The Environment.

MIC Family of Isolators:

  • Meets and/or exceeds all specifications required by USP<797>
  • MIC Isolators are the perfect solution to the restrictive and expensive clean room solution
  • The modular design allows for adaptation to any regulatory change
  • Designed to grow with your facility so your investment never becomes obsolete
  • Completely ready and 100% compatible with the next generation of Advanced Aseptic Compounding™- * Vaporized Hydrogen Peroxide (VHP) decontamination
  • The MIC Isolators do not need to be placed in a clean room regardless of operating under positive or negative pressure
  • Full gowning is not required when using the MIC Isolator
  • The MIC Isolator can be set at negative or positive pressure
  • The MIC does not need to be vented - in fact we recommend against venting while using the MIC Isolator
  • MIC Isolators have unidirectional airflow within the Direct Compounding Area (DCA)
  • Every MIC Isolator is installed by a factory trained professional
  • Every installation includes hands-on and in-depth training for your facility
  • Comprehensive documentation package included with every unit
  • Protects the Provider, the Patient, and the Environment

Comprehensive USP<797> Services Provided by Containment Technologies Group, Inc.

  • Certification services for all primary engineering controls
    • Isolators (CAI/CACI’s), Biological Safety Cabinets (BSC’s), Fume Hoods, Laminar Flow Hoods, Clean Rooms, Surgical Suites
    • Provide both non-viable testing as well as viable air and surface sampling
    • Partnership with a laboratory for all microbiological testing and classifications
    • NSF accredited staff, CETA members, ISPE members, AGS members
  • Training services for all areas of USP<797>
    • Aseptic training for your staff
    • USP<797> regulatory training
    • Media Fill Testing kits as well as training
  • Fully stocked warehouse for all of your pharmacy needs
    • Sterile gloves, sleeves, sharps containers, glove liners, media fill test kits, cleaning supplies, sterile alcohol, hydrogen peroxide, sleeve liners, and many more commonly used consumables

We want to make your life easier! At Containment Technologies Group, Inc., we have a staff of professionals that live and breathe USP<797>. Whether it is providing your facility with products and supplies all the way to certification and training, we are here to provide your facility with a one-stop solution for all of your USP<797> needs.

CTG, Inc. – Your One Stop Solution For All Of Your USP<797> Needs

Containment Technologies Group, Inc. on USP <797>. mic hoods cleanrooms usp <797> CETA Controlled Environment Testing Association pharmacy cleanroom certification and MIC Isolators MIC Family of Isolators, MIC Single, MIC Dual, MIC TPNs and the MIC-EDU Systems.
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mic dual
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USP<797> & USP<800> Resources & Compliance Booth #14732
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Request More Information Visit the Health Care Logistics Website

Health Care Logistics

USP 797 Compliance


Finding products that comply with USP <797> mandates isn’t always easy, but it is essential. And Health Care Logistics has you covered. We offer the most diverse selection of USP <797> and infection prevention solutions in the healthcare industry and we provide all the solutions you need in one convenient location.

Cleaning supplies such as Lint-Free Wipes and Sterile Cleanroom Wipes are great for cleaning lab equipment and medical instruments in areas where bacteria, particulate and extractable levels are critical concerns. Our Cleaning Tools & Supplies can help you achieve quick, effective cleaning and disinfecting in critical areas such as cleanrooms, isolators, restricted access barrier systems, filling lines, laminar flow hoods, cabinets, incubators and glove boxes. And our Infection Control Mats effectively remove dirt, dust and lint on contact from shoes, making it easier than ever to comply with USP <797> mandates!

Could your facility benefit from stainless steel storage containers, lock boxes and utility trays to simplify USP <797> compliance? Do you have an existing product you'd like to upgrade with a specially sized metal adaptor such as a bracket, plate, clamp or hanger that is USP <797> friendly? Whatever solution you seek, HCL can deliver. We create metal products to match your unique specifications so you can work more efficiently and produce better results. Our designers use stainless steel and aluminum, dependent upon your needs, and our design consultation services are always FREE!

USP 797
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USP<797> & USP<800> Resources & Compliance Booth #16125
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Request More Information Visit the IsoTech Design Website

IsoTech Design

IsoTech Design is a leading designer and manufacturer of turnkey barrier isolators, CAI and CACI, modular cleanrooms, and clean air environment solutions for hospitals, pharmacies, and pharmaceutical companies. Our solutions allow a high level of sterility assurance, microorganisms and particle contamination controls, and containment management to comply with the USP <797> and USP <800> requirements for pharmacy sterile and chemo compounding.

IsoTech Design guarantees all of its products and is committed to provide optimum solutions and customer service. Full factory testing is your assurance of reliability. Each IsoTech product is thoroughly inspected in our factory prior to shipment. Our qualified service technicians will do the start-up of the IsoTech equipment along with training and SOP.

Total Solutions for USP 800 Compliance:

The ChemoSphere is a safe, clean, cost-effective C.A.C.I. for chemo compounding that is USP <797>, OSHA, AND NIOSH compliant.

  • ISO Class 4 in the main chamber & ISO Class 5 in the antechamber
  • Unidirectional and negative pressure C.A.C.I
  • Alarms and interlocks for prevention and safety
  • Fast recovery rate (less than 1 minute)
  • Ease of use, ergonomic, easy to install, maintain, and operate
  • Many sizes and options available
  • Optional TSPs : Total Service Plans that include certification, SOPs, and essentials

The SafeAiRx is a ductless fume, particulate & vapor extraction enclosure for safe compounding in the pharmacy.

  • Pulls both horizontally and vertically with a face velocity of 100 fpm
  • Very cost-efficient, no ducting and no installation costs
  • Compact bench mounted unit with a stainless steel work surface
  • Low vibration and turbulence inside the unit
  • Can be ducted to the outside with an HVAC transition collar for USP <800> compliance
  • Optional activated charcoal filter which can be chosen from different types of carbon to ensure bettter protection against fumes, gases and vapors.

We work very closely with our customers to design Clean Air Solutions that meet their needs and all the regulatory requirements to facilitate their processes.

usp 797 usp 800 cleanrooms turnkey barrier isolators clean air environments



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USP<797> & USP<800> Resources & Compliance Booth #16124
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Request More Information Visit the MEDISCA Website

MEDISCA®

Your Trusted Partner in Compounding

With over 25 years of experience, MEDISCA has developed a solid reputation as an innovative and entrepreneurial company in the pharmaceutical compounding industry. MEDISCA is a leading FDA-registered supplier of quality pharmacy compounding products and offers excellent service to the North American, Australian and other international markets. We are dedicated to providing our clients with the highest quality compounding products, such as:

  • Active Pharmaceutical Ingredients (APIs)
  • Fine Chemicals
  • Bases
  • Equipment & Devices
  • Capsules
  • Oils, Flavors and Colors
  • Compounding Kits

Commitment to Quality
Quality is the cornerstone of the MEDISCA brand. This is evident in the design of our facilities around the world and in the people we do business with. In fact, quality is the responsibility of everyone at MEDISCA, and we ensure this high level of quality in several ways:

  • FDA-registered establishment
  • Compliant with current Good Manufacturing Practices (cGMPs)
  • Provide compounding pharmacists with security of supply
  • Ensure the highest quality Active Pharmaceutical Ingredients (APIs)
  • Proactive approach in enhancing quality protocols

We share a passion for quality compounding medications and a wealth of knowledge of the pharmacy marketplace. We are continuously working to improve the quality of customized pharmaceutical care!

Continuous Innovation
Our quest for revolutionary products and innovative devices drives our Research & Development team. We are committed to:

  • Developing innovative, high quality products
  • Continually expanding product lines
  • Monitoring industry trends
  • Being a leader in pharmaceutical compounding

Exceptional Customer Service
We take pride in our exceptional service and consistently strive to exceed customer expectations. We are proud to offer:

  • Personal sales representatives
  • Experienced technical support professionals
  • Reliable and personalized attention
  • Excellent online services and support including:
    • Convenient and secure online ordering available 24/7
      • Easy access to view your special contract pricing
      • Quick access to view and track recent orders
      • Easy to browse and search for products
      • Access to MEDISCA TV, providing informative about new product innovations and our continuous commitment to quality.

MEDISCA
Your Trusted Partner in Compounding

Pharmacy Compounding Supplies formulating Training, Blending Compound Chemicals, Mixing Equipment sets, Quality Control Testing compounding recipes CE Education sterile techniques resources quality control customer service community FDA registered cGMP Independent Pharmacies powder Hospitals distribution, bases, lab devices, natural oils bases oils capsules flavors colors devices training bases oils capsules flavors colors devices training
Medisca Compounding
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USP<797> & USP<800> Resources & Compliance Booth #14731
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Request More Information Visit the Acute Care Pharmaceuticals Website

Acute Care Pharmaceuticals

Acute Care Pharmaceuticals is located in San Diego, California. We are a full-line pharmaceutical wholesaler and USP <797> & USP <800> compliant cleanroom disposables manufacture. Since our founding in 1997, we have been continually licensed by, and in good standing with, the California State Board of Pharmacy.

For over 20 years Acute Care Pharmaceuticals has been servicing the healthcare industry by delivering exceptional products and services to healthcare providers nationwide. We offer a wide range of USP <797> and <800> compliant disposable products that are manufactured under the highest standards. Our USP <797> compliant product line includes sterile alcohol, non-linting wipers, disinfectants, gloves, media test kits, apparel, and more.

Looking toward the future and developing products that exceed your expectations is our number one goal. Our new USP <800> line of products was developed with you in
mind, because your safety and the safety of your employees matter.

USP 800 Products include:

  • Chemo gowns
  • Chemo gloves
  • Chemo spill mats
  • Goggles
  • Respiratory masks
  • Sterile apparel
  • Two-Step chemo neutralizing kit

ISO Cleanroom Standards
Acute Care Pharmaceuticals meets ISO Class 5 standards on all of our wipers and ISO Class 5-6 on our new Pharma-Sat™ Canisters. This demonstrates our commitment to quality in the design and manufacturing of its cleanroom disposables.

With an excess of 20 GPO and IDN contracts, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ Brand of products are stocked at AmerisourceBergen, Cardinal, and McKesson, where you can receive your special discounted contract pricing.

If you want quality products and customer service that you can count on, call us today at 1-888-909-7700 for more information and your GPO contracted pricing.

acute care pharmaceuticals, USP <797> International Organization for Standardization cleanroom supplies pharma choice pharma stat canister wipes





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USP<797> & USP<800> Resources & Compliance Booth #11520
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Request More Information Visit the Medi-Dose Website

Medi-Dose

The Medi-Dose® Group, known for its innovative solid and liquid oral unit dose packaging systems, has always had deep roots---family roots. This is not surprising since Medi-Dose began as a small family business. Medi-Dose was founded in 1971 when Milton Braverman, a former pharmaceutical company Territory Manager, formed his own company.

The requirements of USP <800> prohibit the use of automated packaging for hazardous medications. Fortunately, the Medi-Dose® unit dose system has been designed to be the easiest, fastest, and most cost-effective way to unit dose and bar code your inventory. Because of its unique Cold-Seal technology, the Medi-Dose System is simple to use, requires no special in-service training or additional space and can be an essential part of your USP <800> compliance plan.

The finished package provides tamper-evidence, ultraviolet inhibitance, moisture protection … and even 1-year beyond-use dating! There are 13 different styles of blisters, including JUMBO blisters for large tablets or capsules, MINI blisters designed for saving space in medication bins, and OVAL blisters for a variety of dispensing cabinets.

Medi-Dose’s MILT® software provides complete medication identification and bar coding capabilities for all your labeling needs:

  • Solids
  • Liquids
  • Syringes
  • Ampules
  • IV’s
  • Equipment

It includes a wide library of auxiliary label images with special emphasis on those calling attention to the special handling required for meds covered by USP <800>. Flexible formatting (different colors, fonts, even Tall-Man Lettering), laser and thermal printing, and customizable workflow for your facility are all available through the program.

Unit Dose Supplies, Unit Dose, Barcoding, Supplies, pharmacy supplies
IV Supplies
IV Supplies
Flag Labels
IV Supplies
IV Supplies
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USP<797> & USP<800> Resources & Compliance Booth #16117
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Request More Information Visit the CriticalPoint Website

CriticalPoint strives on increasing patient safety through a variety of educational offerings focusing on UPS <797> and <800>. Partnering with industry experts, we provide the most current and engaging training on industry standards resulting in improved competency and patient safety.

*NEW ANNOUNCEMENT*

The 2017 USP Chapter <797> & <800> Compliance Study is now OPEN and will run through June 30, 2017. To participate in this year's Study and use the Gap Analysis Tool, visit http://bit.ly/797study-criticalpoint-info and use the Survey Code G797RX. The study gives you the opportunity to perform a complete USP <797> and <800> gap analysis or you have the option to answer questions related to just <797> or <800>, all from one login.

Qualified Person Certification Program for 503A and 503B Personnel

CriticalPoint is launching its QP503A™ and QP503B™ Certifications in 2017. Successful completion of these program requirements will result in the acquisition of specific essential knowledge and skills that will facilitate an individuals’ ability to successfully plan, develop and operate a 503A pharmacy sterile compounding operation or 503B Entity.

Sterile Compounding eLearning

CriticalPoint offers a wide range of web-based training focusing on standards and best practice. Written by the industry experts, you can be guaranteed you are receiving the best training available. Each course is continuously reviewed and updated so you can be assured you are receiving the most current information.

CriticalPoint’s engaging and interactive online training is available anytime and anywhere from any computer. In addition, each of our lessons offer ACPE - Approved continuing education credit hours for both pharmacists and technicians.

Hands-On Training for USP <797> and <800>

Do you Want to be Taught in a State-of-the-Art Cleanroom Facility by the Best in the Business?
CriticalPoint has expanded it training efforts to include several live training classes at our state-of-the-art facility, the CriticalPoint Center for Training and Research, located in Totowa, NJ. These classes are designed to incorporate didactic e-learning, lecture and labs to provide top-notch training on Best Practices as well as USP compounding requirements.

  • Our 2-½ day Sterile Compounding Boot Camp indoctrinates and immerses learners into current sterile compounding best practices through e-learning, classroom and realistic workplace simulations. Attendees will receive 29.5 CE credit hours (10 hours e-learning home study and 19.5 hours of live training)

  • Combining eLearning, Lecture and Labs, the Best Practices for Handling Hazardous Drugs this 1-½ day class is taught by expert instructors and covers all aspects of handling hazardous drugs and Chapter <800>. Students will review current and proposed regulation concerning all aspects of handling hazardous drugs (HDs)s as well as practice donning and doffing PPE; negative pressure sterile compounding and HD spill cleanup. Attendees will receive 17 CE credit hours (5 hours eLearning home study and 12 hours of live training).


Model Standard Operating Procedures (SOPs)

Detailed standard operating procedures are the foundation of a robust sterile compounding practice. When written properly, they should tell the reader exactly what to do as well as why, where, when and how to perform the activity.

We have partnered with Clinical IQ to capture their expertise through the development of a set of template policies, procedures and accompanying documentation forms (together referred to as the SOPs).  They are effective in establishing robust operating procedures that ensure patient safety.

These detailed procedures and forms reflect not only guidance to foster achievement of compliance with Chapter <797> and Chapter <800> but with aseptic processing best practices as well. They are continually refined and updated to reflect regulatory changes (like Chapter <797> and Chapter <800> revisions). They are consistent with the CriticalPoint eLearning Training while providing more specific “how to” detail in regards to process as well as documentation. The SOPs can be harmonized to match the actual working conditions of your compounding facility and practice. Purchase of these SOPs includes lifetime access and updates.

USP <800>, USP <797>, USP 800, USP 797, Hazardous Drug Safe Handling, Sterile Compounding, Training, CriticalPoint, Live Training, Sterile Compounding Boot Camp, QP503A, QP503B



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USP<797> & USP<800> Resources & Compliance Booth #16115
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Request More Information Visit the The Baker Company Website

The Baker Company

Pharmacy Compounding Solutions

Baker has a long history of providing the highest quality containment and clean air products for retail, hospital and clinical pharmacy applications. Our products continue to set the industry standard for safety, performance, operating efficiencies and ergonomics through innovative research, meticulous engineering and on-going testing.

With pharmacy laws, guidelines and regulations targeting the preparation of sterile injectable drugs, clean air and containment equipment is playing an increasingly critical role in day-to-day pharmacy operations. Laminar-flow clean benches, gloveboxes and biological safety cabinets are required in-house elements for minimizing potential contamination and exposure during compounding.

Solutions from Baker

For 60 years The Baker Company has been helping our customers advance science, discovery, and clinical care by providing the right equipment to meet their needs. We look forward to working with you!

We are committed to helping you protect your patients and employees, and offer a full range of products to help you be compliant with USP <795>, <797>, and <800> including:

PHARMACY GLOVE BOXES

  • SterilSHIELD® Compounding Aseptic Isolator

Positive pressure sterility assurance barrier glove box for complete product protection when compounding non-hazardous pharmaceutical compounds and related clinical, pharmacy and process applications.

  • ChemoSHIELD® Compounding Aseptic Containment Isolator

For sterile compounding of hazardous or potent pharmaceutical compounds, chemotherapy agents and IV admixtures that can be harmful to pharmacy personnel.

BIOSAFETY CABINETS

  • SterilGARD® e3, Class II, Type A2 Biological Safety Cabinet

The most energy efficient, comfortable and safe A2 cabinet in the industry, the SterilGARD e3 is designed for sterile product preparation and biological experimentation involving agents of low to moderate risk. Also available is the compact model SG-303, a 3-foot biosafety cabinet with a smaller footprint for low-volume facilities.

  • BioChemGARD® e3, Class II, Type B2 Total Exhaust Biological Safety Cabinet

The BioChemGARD® e3 is a breakthrough in total-exhaust biological safety cabinets. Engineered specifically for laboratories that need containment and removal of vapors, mists and particulates, the BioChemGARD e3 has a revolutionary airflow system that increases users’ comfort and productivity while decreasing the overall operating costs. Designed for biological testing and product preparation involving low to moderate risk agents where chemical effluent is present and clean air is essential.

LAMINAR FLOW CLEAN BENCHES

  • EdgeGARD® HF Clean Bench

With a spacious work area and brightly illuminated for maximum productivity and unique high velocity air return slots, EdgeGARD® HF Clean Bench offers both user comfort and product protection. Horizontal and vertical flow models are available.

OPTIONAL REMOTE COMPOUNDING VALIDATION PACKAGE

  • Phocus Rx Remote Compounding Validation

Phocus Rx remote compounding validation system from Grifols is a “plug & play” solution that provides a safe, reliable and easy-to-use environment to document and validate the compounding of prescription IV drugs. The system improves quality assurance and workflow efficiency by helping to ensure that medications are prepared correctly and labels are accurate. Baker biosafety cabinets and clean benches are available fully integrated with Phocus Rx.

The Baker Company, laminar flow hoods, pharmacy hoods, cleanrooms, usp 797




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USP<797> & USP<800> Resources & Compliance Booth #14735
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Request More Information Visit the Phononic Website

Evolve

Utilizing solid-state refrigeration technology, Evolve is designed for high-performance refrigeration in pharmaceutical and clinical applications. The innovative solid-state technology makes Evolve the most advanced system for high-performance refrigeration, providing the best available temperature uniformity and stability to properly store high-value products while adhering to USP <797> and USP <800> standards.
Solid-state refrigeration is recommended for use inside USP <797> and USP <800> environments because it eliminates the two most prevalent sources of contamination found in compressor based system: metallic particulates and greases, oil, or other lubricating materials. Evolve significantly reduces installation costs because there is no need for costly renovation projects to exhaust the rejected air out of the cleanroom environment. In addition, the new guidelines restrict the use of fixed, pass-through refrigerators in the USP <800> environment as they can pull air from the uncontrolled external environment into the negative pressure environment leading to contamination. Evolve is the safe option for medical-grade solid-state refrigeration inside your cleanroom.

More Capacity. Same Footprint
The most common request that the Evolve team hears from compounding professionals is for more space, as most cleanrooms are cramped and space is at a premium. Another benefit of the solid-state refrigeration system is that the cooling system is much smaller than compressor dependent systems. The space saved in the cooling system can then be re-purposed into additional cold storage capacity. When compared to other ADA compliant undercounter refrigerators, Evolve has up to 25% more storage capacity with the same external dimensions.

Evolve compressor-free refrigerators also provide:

  • Superior temperature uniformity (+/- 1 °C) and stability (0.2 °C)
  • Ultra quiet operation (less than 35 dBA)
  • Industry best 10-year warranty

Evolve 5.5 cu. ft. ADA Undercounter Refrigerator
Model ELR055SSA-002 – Solid Door
Model ELR055SGA-002 – Glass Door

Product Features:

  • Dual cooling system delivering precise temperature control in the +2°C to +8°C range
  • Exceeds CDC recommendations for drug & vaccine storage with its no-freeze zone
  • Compatible with Pyxis ™ and Omnicell ™ locking medication management systems
  • Available NIST traceable calibration certificate
  • Optional SilverPoint local and remote temperature monitoring system

Evolve 1.8 cu. ft. Compact Refrigerator
Model ELR018SSA-008

Product Features:

  • Meets the CDC recommendations for drug & vaccine storage
  • Precise temperature control within a +2°C to +8°C range
  • Compatible with Pyxis® and Omnicell® locking medication management systems
  • Available NIST traceable calibration certificate
  • Optional SilverPoint local and remote temperature monitoring system
usp 800 usp 797 compliance phononic evolve vaccine refrigerator




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USP<797> & USP<800> Resources & Compliance Booth #16120
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Request More Information Visit the QI Medical Website

QI Medical

Your source for products to support compliance with USP 797, USP 71, USP 800.

For over 20 years, Q.I. Medical has been a trusted provider of quality assurance products to compounding pharmacies throughout the world. Our focus is on developing
easy-to-use products for our customers to help them with their in-house testing needs. Whether it is a low, medium, or high risk facility, Q.I. Medical can help them to be in compliance with regulatory guidelines (USP <797>, USP <71>, 503a or 503b, etc.).

We offer unique products for pharmacists and nurses who handle sterile solutions. Our focus is on devices, test kits, and accessories that improve aseptic technique.

Applications include:

  • Environmental Monitoring
  • Technique and Process Validation
  • Microbial and Endotoxin Contamination Testing
  • Filtration
  • Needless Dispensing
usp 797, usp 800, hazardous drug, sterility testing, environmental monitoring, dispensing, filtration, contamination testing, endotoxin




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Medi-Dose, Inc./EPS, Inc. Delivers Bar Coding, Packaging, and Labeling Pharmacy Solutions

Improve your Solid Oral Unit Dose needs with our comprehensive Bar Coding, Packaging, and Labeling Solutions - designed by healthcare professionals, for healthcare professionals.

Read More Summer 2017 Edition | Health System - Infusion

ISOlutions for Cleanroom and Medical Supplies by ISO-MED, Inc.

Your one-stop-shop for all your USP 797 and USP 800 needs.

Read More Summer 2017 Edition | Health System - Infusion

Hardy Diagnostics: Your USP 797 Compliance Advocates in Microbiology

Hardy Diagnostics is an FDA registered and inspected ISO 13485 Microbiology Media Manufacturer with a "culture of service." Our robust quality standards and personal attention make us well poised to assist with USP 797 related products to help you meet regulatory requirements.

Read More Summer 2017 Edition | Health System - Infusion

Prep-Lock ™ From IMI Guards Against Drug Diversion and Misuse

Increase pharmacy productivity and safety with innovative and economical devices designed to protect your compounded sterile preparations.

Read More Summer 2017 Edition | Health System - Infusion

MEDISCA's Mazerustar Mixer - One Single Revolutionary Mixing Technology for Compounders

MEDISCA's Mazerustar provides pharmacists with a revolutionary way to compound. This integrated mixer is taking mixing technology to the next level with its multiple capabilities such as mixing, deaerating, melting, and milling.

Read More Spring 2017 Edition | Community - Specialty - LTC

The Pyrosate ® Kit by Associates of Cape Cod Delivers Rapid Endotoxin Testing Results for Compounding Pharmacies

Pyrosate ® has been developed as an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The Pyrosate kit provides rapid results and is especially convenient for research, testing water, and dialysate.

Read More Winter 2016 Edition | Community - Specialty - LTC

Associates of Cape Cod - Delivering Rapid Endotoxin Testing Results for Compounding Pharmacies

Pyrosate ® has been developed as an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The Pyrosate kit provides rapid results and is especially convenient for research, testing water, and dialysate.

Read More Winter 2016 Edition | Health System - Infusion

With PCCA, Membership Means Partnership

Compounding pharmacists make a difference for patients. As the industry's most comprehensive resource, PCCA makes a difference for compounding pharmacists, offering the highest quality products, education, and support.

Read More Winter 2016 Edition | Health System - Infusion

With PCCA, Membership Means Partnership

Compounding pharmacists make a difference for patients. As the industry's most comprehensive resource, PCCA makes a difference for compounding pharmacists, offering the highest quality products, education, and support.

Read More Winter 2016 Edition | Community - Specialty - LTC

Innovative Sterile Products for Compounding and Hospital Pharmacies by International Medical Industries, Inc.

Increase pharmacy productivity and safety with high-quality and economical sterile products designed to meet the demands of sterile compounding. Easy-to-find and easy-to-order through IMI or one of our valued distribution partners.

Read More Summer 2016 Edition | Health System - Infusion

PCCA - The Industry's Most Comprehensive Quality Control and Assurance Program

The broadest products and services available backed by the most dedicated team in the industry.

Read More Summer 2015 Edition | Health System - Infusion

USP <797> and USP <800> Cleanroom Disposables by Acute Care Pharmaceuticals

Manufacturing USP <797> and <800> compliant products for your advanced environment.

Read More Summer 2015 Edition | Health System - Infusion

Clean Air Solutions by IsoTech Design

Cost effective, safe and USP <797> compliant clean air solutions for sterile and hazardous compounding. We protect life with contamination control, sterility assurance and containment management. Why build a constructed clean room?

Read More Winter 2014 Edition | Health System - Infusion

Pyrosate® - Rapid Endotoxin Detection Kit by Associates of Cape Cod, Inc.

Pyrosate® has been developed as an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The Pyrosate kit provides rapid results and is especially convenient for research, testing water and dialysate.

Read More Fall 2014 Edition | Community - Specialty - LTC

Sterile Compounding Devices - Prep-Lock Tamper Evident Syringe Caps by International Medical Industries, Inc.

Enhance the security and integrity of your Compounded Sterile Preparations with the industry standard in Tamper Evidence.

Read More Summer 2014 Edition | Health System - Infusion

Pharma™-Wipe Plus - USP <797> Compliant Wipers by Acute Care Pharmaceuticals

Acute Care Pharmaceuticals manufactures advanced USP <797> compliant disposables for advanced environments.

Read More Summer 2014 Edition | Health System - Infusion

Minimize Risk. Maximize Compounding Accuracy. With NuAire Inc.'s PharmaGard NU-797 Isolators.

NuAire's mission has always been to develop and deliver innovative products, communicate the latest technologies and product improvements, establish trust in products, personnel, to seek customer satisfaction and continuously improve our mission.

Read More Summer 2014 Edition | Health System - Infusion

Chemotherapy Training Kit for Pharmacy by Health Care Logistics

A smart choice for USP <797> compliance!

Read More Summer 2013 Edition | Health System - Infusion
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Acute Care Pharmaceuticals

USP <797> and USP <800> Compliant Supplies

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Cleanroom Connection

Your USP 800 Compliance Solution.

Read More

Contec

PeridoxRTU® Sporicidal Disindectant Cleans, Disinfects, and Decontaminates

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Labconco

Filtered Balance Systems for Non-Sterile Compounding.

Read More

Iso-Med

ISOlutions for your Cleanroom. Products for USP 797 and USP 800 Compliance!

Read More

IsoTech Design

Total solutions for USP <797> and <800> compliance

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IsoTech Design

Your total clean air solution provider for USP <797> and <800> compliance

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Prudential Cleanroom Services

USP <797> & USP <800> Complete Reusable Garment Rental Program

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Associates of Cape Cod, Inc

Pyrostate® Rapid Endotoxin Detection Kit

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Helmer Scientific

Only the best for your temperature sensitive pharmaceuticals.

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Evolve a Phononic Brand

Evolve medical-grade refrigerators provide a complete solution for protecting vaccines, medications, and temperature sensitive materials.

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Medi-Dose

High quality, safe, and effective products for medication administration, preparation and dispensing .

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Wolf Medical Supply

USP <800> Cleanroom and Infusion Supplies

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Acute Care Pharmaceuticals

Pharma-Choice™ by Acute Care Pharmaceuticals

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Containment Technologies Group

The MIC family of products are the perfect solution to your hazardous compounding needs.

Read More

ISO-MED

Products for your USP 797 and USP 800 compliance!

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Simplex Isolation Systems

The leader in USP 800 Cleanroom Technology

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The Baker Company

What does USP <800> mean for your facility?

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MEDISCA

MEDISCA is your turnkey solution for an easier transition.

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LP3 Network

Participate in our hazardous drug compounding training and webinars.

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Medi-Dose

Unit Dose, Bar Coding, Pharmacy & Nursing Supply Experts!

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Helmer Scientific

Cold Storage for your USP <800> Cleanroom

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Q.I. Medical

EnviroTest ™ , See What You're Missing

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CleanAir Solutions

USP <800> Hazardous Compounding Integrated Cleanroom Systems

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IVQA

USP < 797> Compliant Media Fill Test Kits

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Prudential Cleanroom Services

Allow PCS to help you meet your new gowning requirements for USP 797 & 800.

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Contec, Inc.

Safer Pharmacies with a Squeeze of PeridoxRTU®

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Evolve, a Phononic Brand

Uniformity and Stability - Protect What Matters

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IsoTech Design

Total solutions for USP <800> compliance.

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Texwipe

The Leader in Critical Cleaning.

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CriticalPoint

Offerings for USP <800> include eLearning, live training, and standard operating procedures.

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PCCA

Products. Education. Support.

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Berkshire

The EasyClean 360 Isolator Cleaning Tools unique shape and size provides the ideal contours and surface area for cleaning and disinfecting tight workspaces including LAFWs, BSCs, CAIs, and CACIs. Berkshires extensive customer support team, website, online store, and local distributor networks are integral components of the experience and expertise valued by Berkshires customers.

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USP<797> & USP<800> Resources & Compliance

CAPS Consulting - Let Our Team Help Your Team.
We have over 20 years of active pharmacy and clean room experience with expertise in USP <797>, the Drug Quality and Security Act (DQSA), and more. CAPS Consulting is a team of compounding experts prepared to help pharmacies reach their compliance standards.
Pharmaconomics, Inc.
Pharmaconomics is a leading developer of niche pharmaceutical software dedicated to supporting the practice of pharmacy. Our products feature advanced technology solutions that help simplify many of the complex requirements faced by pharmacists.

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