Clean Air Technology: Pharmacy Isolators, Pharmacy Cleanrooms & Fixtures, Chemo Hoods, Sterile Room Medication Preparation, Barrier Isolators, Chemo Gloveboxes...
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USP 797 Compliant Cleanrooms
QleanSpace is a turn-key cleanroom with guaranteed functionality. Our highly adaptable solutions have short installation time, and provide a safe and efficient environment for your pharmacy operation. All components are factory-assembled and tested before shipping. QleanSpace will help you transform your existing pharmacy environment into a facility with USP<797> and/or cGMP compliance.
QleanSpace constantly monitors the level of airborne particles, the pressure levels, the temperature and humidity, and displays them on screen to make all data easily readable by the staff inside and outside the area. Warning signals are issued at pre set levels when approaching the cleanroom rating limits.
USP 800 Compliant Cleanrooms
QleanSpace’s compliant cleanrooms extend the protection to health care personnel from exposure to hazardous drugs. Having a Qleanspace cleanroom means you have a future proof solution from both, regulatory mandates as well the ability to change, move or expand as you grow. Our turn-key cleanrooms include guaranteed functionality.
Other benefits to having Qleanspace cleanrooms are, short installation time to not interfere with a demanding schedule, being pharmacy retrofit, and most importantly, providing a safe and efficient environment for your pharmacy operation. QleanSpace can be configured to meet cleanliness requirements to Class 100/ISO 5 using HEPA or ULPA fan/filter modules for control of submicron particles.
Hazardous Drugs Storage Rooms
Having safe and easily obtainable access to your hazardous drugs can save you valuable time, and give you the advantage of not having to outsource. QleanStore is our hazardous drug storage area, separate from other inventory to prevent contamination and personnel exposure. QleanStore is engineered to be a negative pressure room with at least 12 air changes per hour (ACH), and meets USP <800> standards. HDs are stored at, or below eye level on secure shelves with raised front lips to avoid accidental falling. All these features we put into our QleanStore helps protect your people, products, and processes.
Rental Option with Performance Guarantee
Our RPG (Rental with Performance Guarantee) rental option includes full service and maintenance, with a full guarantee of the facility and its function with no upfront or start-up costs.
Become a QleanAir partner, and future-proof your operations with adaptable, innovative 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.
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
Positive pressure sterility assurance barrier glove box for complete product protection when compounding non-hazardous pharmaceutical compounds and related clinical, pharmacy and process applications.
For sterile compounding of hazardous or potent pharmaceutical compounds, chemotherapy agents and IV admixtures that can be harmful to pharmacy personnel.
BIOSAFETY CABINETS
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.
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
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 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.
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Modular Cleanrooms knows cleanrooms can be constructed out of many varying materials from sheet rock to flexible vinyl, but no matter what material it is, the HEPA filter is the heart of every Cleanroom. That is why Modular Cleanrooms is a Master Distributor of Envirco Corp. and has the largest inventory in the central US of Mac 10 Fan Powered HEPA Filters. Along with the Mac 10 filters we stock several styles and sizes of cleanroom light fixtures (T8 with electronic ballasts) in standard Troffer and Flo-Thru styles, Suspended “T” Bar ceiling grid and ceiling tiles. We also stock replacement motors, pre-filters and HEPA filters (standard and RSR) for the Mac 10 series of Fan Filter Units (FFUs). Modular Cleanrooms is also able to purchase replacement HEPA filters directly from the manufacturers for most popular brands of FFUs.
The Econo-Tent softwall cleanroom is the most economical approach and design for your cleanroom needs. This design is commonly used in the microelectronics and medical mold injection industry as well as many others. Econo-Tent's softwall design allows it to be used as either a totally freestanding room or it can be used in combination with your existing walls and ceiling. Each room comes completely factory prefabricated for minimal on-site erection time and is totally self-contained with all components factory-finished.
Modular Hardwall Cleanrooms are prefabricated, factory engineered and designed to meet a full range of cleanroom requirements found in industries ranging from Micro-Electronics, Aerospace, Medical equipment and packaging. Modular Hardwall Cleanrooms are also an excellent product for the Compounding Pharmacy market. They meet and exceed all of the requirements found in USP 797.
The Aluminum Bio-Clean design emphasizes particle infiltration as well microbial contamination protection. The Aluminum Bio-Clean can be designed and certified to as clean as Class 10 (ISO 4) up to Class 100,000 (ISO 8) as well as Class 10,000 for USP 797. Each Aluminum Bio-Clean cleanroom can also be outfitted with Class 100 (ISO 5) work zones eliminating the need for (ISO 5) Clean Benches/Hoods.
The Micro-Clean cleanroom is specifically designed to meet requirements of the medical and pharmaceutical industries. Micro-Clean's design allows it to be used as either a totally freestanding room or it can be used in combination with your existing walls and ceiling. The Micro-Clean comes completely factory prefabricated for minimal on-site erection time and is totally self-contained with all components factory finished.
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Prepare for USP 800 – NuAire, Inc.
NuAire is committed to creating quality, long-lasting products designed to cost less with an emphasis on your safety. Put your trust in NuAire and see why NuAire is the safer choice for your pharmacy.
Company Background
For over 40 years, NuAire has been recognized as the leader in providing pharmacy professionals with reliable products with the best performance and best protection for the most demanding environments.
Max D. Peters founded NuAire in 1971, on the principle: “the best in industry service, expert knowledge, and consistently providing quality laboratory equipment.” Every product is built exactly to your order. NuAire builds integrity and reliability into every product utilizing True Laminar Airflow, the HEPEX™ Zero Leak Airflow System, state-of-the-art electronic systems, and ergonomic design.
Product Overview
NuAire’s PharmaGard Compounding Isolators meet the USP 800 standard for Hazardous Drugs – Handling in Healthcare Settings. PharmaGard Isolators create an ISO Class 5 sterile environment, meeting the requirements of USP Std. 797 for compounding of sterile products. NU-PR797 Positive Compounding Aseptic Isolator, NU-NR797 Negative Pressure Re-circulating Compounding Aseptic Containment Isolator, and NU-NTE797 Negative Pressure Total Exhaust Compounding Aseptic Containment Isolator. NuAire also offers energy efficient biological safety cabinets and laminar flow clean benches for use in ISO Class 7 cleanrooms.
Features & Benefits
NuAire offers a Class 1 Biological Safety Cabinet (BSC) that can be exhausted or recirculated back into a negative pressure room through a redundant HEPA filter system.
NuAire’s Compounding Aseptic Containment Isolators (CACI) and Class II BSCs allow camera to be externally mounted to support surveillance and documentation programs. A computer monitor with keyboard/mouse arm can be added to your CACI or BSC allowing technician’s easy access to compounding and cleaning SOPs.
NuAire is also a manufacturer of Laminar Airflow Workstations (LAFWs), Compounding Aseptic Isolators (CAIs), and custom airflow solutions designed to meet the needs of USP 797 and the proposed USP 800.
NuAire’s PharmaGard™ Compounding Isolators meet the USP 800 standard for Hazardous Drugs
– Handling in Healthcare Settings. Each PharmaGard can assist with your documentation and surveillance programs as proposed by USP 800 by mounting external camera to monitor compounding, cleaning, and more. Specialty ergonomic items, such as monitor and keyboard/ mouse arm, can be installed to easily view protocols, document procedures, and more.
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Nonsterile hazardous drug handling processes
About Barrier Isolators (for Hospital Pharmacies and Hospital Labs)
From Wikipedia 2010
A barrier isolator, or simply an isolator, is a device that provides a physical barrier between a pharmacist or technician and a work process. Isolators are routinely found in the pharmaceutical industry within hospitals, and with the recent implementation of USP 797 ("Pharmaceutical Compounding: Sterile Preparations", a set of sterile compounding standards issued by the United States Pharmacopeia), are increasingly used in pharmacy applications. They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile or aseptic). Isolators may operate at positive, negative, or ambient differential pressure. Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic drug compounding to electronics manufacturing.
Regarding pharmacy applications within hospitals, because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product. In the mid 1980's, the industry began to employ barrier isolators, and later, in the 1990s, Restricted Access Barrier Systems, or RABS, to separate people from the process. The acronym RABS was coined by Stewart Davenport of Upjohn (now Pfizer). Since that time, the technology and applications of these systems has developed and broadened significantly.
Quality and dependability for the future. For over 30 years NuAire has been universally recognized as the leader in providing laboratory professionals with reliable products for the most demanding environments. NuAire manufactures Biological Safety Cabinets, CO2 Water-Jacketed Incubators, Laminar Airflow Equipment, Ultralow Temperature Freezers, and variety of complementary products and systems to serve the needs of the world's laboratory community.The Baker Company
When you use a Baker biological safety cabinet, fume hood or clean bench, you will enjoy total confidence in its design, performance and containment capability within the broadest performance envelope possible. The Baker Company commitment to the clean air industry includes significant investments in testing, documentation and computerized, state-of-the-art research laboratories capable of simulating and controlling various common laboratory airflow environments.IsoTech Design
IsoTech Design: Our compounding aseptic isolator, modular clean rooms, and microenvironment systems provide a more cost-effective solution than traditional cleanrooms.solution (investment operation and maintenance ) versus traditional cleanrooms to provide a high level of sterility assurance, control microorganisms and particles contamination and provide containment management to meet the USP requirements (Chapter <797>) for pharmaceutical compounding and sterile preparations.
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