Analytical Testing & Quality Control Solutions

Leading Providers of Analytical Research, Analytical Testing, Pharmacy Quality Assurance, Pharmacy Quality Control, USP Protocol, Pharmacy Laboratory Services

Analytical Testing & Quality Control Solutions Booth #16107
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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.

associates of cape cod incorporated, LAL products, LAL accessories, LAL regents, Chromo-LAL, Instrumentation Software
Associates of Cape Cod, Inc.
LAL Products
LAL Accessories
Software
ACCI Services
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Analytical Testing & Quality Control Solutions Booth #16109
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Request More Information Visit the Front Range Labs Website

Front Range Labs

We are a full-service independent laboratory that has been a trusted partner of the compounding pharmacy community for more than 25 years. With a lab staffed by scientists and industry experts, Front Range Labs is well-equipped to serve all compounding pharmacies... 503A OR 503B.

SERVICES

Sterility

Our sterility testing methods will evaluate your compounded sterile products for the presence of viable bacteria as required by USP<797>.

USP<71> is our road map for analysis. Your products are tested within an ISO 5 environment by aseptically trained technicians.

Based on your testing requirements, we can peform and provide a Certificate of Method Suitability according to USP<71>for your formulation.

Bacterial Endotoxins

We offer bacterial endotoxin testing methods to screen your compounded products for the presence of pyrogen as required by USP<797>.

Our Microbiology Department is able to complete bacterial endotoxin analysis within a 24 hour period. We are able to help you determine the Minimum Valid Concentration, Maximum Valid Dilution and the Endotoxin Release Limit for your specific product.

Based on your testing requirements, we can perfom and provide a Certificate of Verification according to USP<85> for your formulation.

Potency

Knowing the correct concentration of your active ingredient within a compounded product is an important component in the quality control process for any compounding pharmacy. In fact, it is required per USP<795> and <797>.

Our chemistry department uses USP-Verified Methods, USP<1226>, or In-house Validated Methods, USP<1225>, to ensure your products are tested correctly. In every test possible we use USP-sourced reference standards.

The following is just an example of the additional comprehensive testing we can provide:

Stability Studies
API Testing
Bulk and In-process analysis
Chemical Identification
Preservative Effectiveness and Efficacy
Dissolution
Method Development
Bioburden/Total Plate Count
Growth Promotion




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Analytical Testing & Quality Control Solutions Booth #303
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Request More Information Visit the ARL Analytical Research Labs Website

ARL Analytical Research Labs

Analytical Research Laboratories (ARL), a division of ARL Biopharma, has been serving the pharmaceutical and health-related industries since 1994. With over 100 years of combined experience in the industry, ARL can meet and exceed your analytical needs. We offer a full range of professional laboratory services, both analytical and microbiological, as well as consulting services, research and development and forensic legal support. ARL’s professional staff can respond to even the most unusual requests. We use state-of-the-art instrumentation, and provide rapid turnaround time and personal service. Contact us for additional information or a detailed quote.

Laboratory Services
Analytical Research Laboratories (ARL) offers complete analytical services utilizing state-of-the-art instrumentation, including Gas Chromatography (GC), Liquid Chromatography (LC) and Mass Spectrometry (MS). ARL also provides compendial testing according to USP/NF, BP, EP, JP, and ACS monographs. In addition to our analytical testing capabilities ARL has a microbiology department for sterility, fungal, endotoxin testing, cell culture tests, bacterial and fungal identification, and preservative effectiveness testing.

ARL is registered with the Food and Drug Administration (FDA) as an analytical laboratory and the Drug Enforcement Administration (DEA). Analytical Research Laboratories operates in compliance with the Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) requirements.

There are many services ARL can provide to be a full service laboratory or to compliment your current in-house laboratory to meet your outsourcing needs.

Forensics/Legal
As a forensic toxicologist, Dr. Kupiec has provided consultation and expert witness testimony in the field of forensic toxicology and pharmaceutical sciences. He has testified in over 100 cases in municipal, state and federal courts, involving both civil and criminal issues.

Research and Development
ARL works with clients daily, utilizing cutting edge technology to develop products ranging from pharmaceuticals, medical devices and over-the-counter products to take to market. These services range from consultation contract to providing full laboratory services and outsource services for pharmaceutical companies.

The parent company of Analytical Research Laboratories, ARL Biopharma, also holds the renowned DNA testing company DNA Solutions. DNA Solutions is leading the trend in looking to the future of medical treatments including pharmacogenomics and gene therapy. By having the capability to provide analytical testing services as well as the DNA testing and sequencing services the possibilities are limitless with ARL Biopharma.

There are many services ARL can provide to be a full service laboratory or to compliment your current in-house laboratory to meet your outsourcing needs.

Pharmaceutical Sterility Testing, Compound Endotoxin Testing, Drug Potency Determination, Medication Stability Studies, cgmp JCAHO Compliant Sample Testing, FDA registered Aseptic Technique Kits, forensic testimony legal services fda Pharmaceutical Sterility Testing, Compound Endotoxin Testing, Drug Potency Determination, Medication Stability Studies, cgmp JCAHO Compliant Sample Testing, FDA registered Aseptic Technique Kits, forensic testimony legal services fda
Analytical Research Laboratories / ARL
Analytical Research Laboratories / ARL
ARL - Quality Control Testing Services
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Analytical Testing & Quality Control Solutions Booth #16108
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Request More Information Visit the Eagle Analytical Services / PCCA Website

Eagle Analytical Services

Support Beyond the Test

Eagle Analytical Services specializes in Quality Assurance/Quality Control testing for the compounding pharmacist. QA and QC are becoming ever more important in today’s compounding pharmacy environment. Heightened public awareness, increased regulatory attention, and most importantly, the desire of pharmacists to provide the highest quality preparations for their patients, while improving their pharmacy operations, have all created increased interest in QA and QC. Dedicated to the unique needs of compounding pharmacies, Eagle provides USP Sterility (bacterial and fungal), USP Endotoxin and active ingredient Potency Testing. For rapid sterility testing, Eagle Analytical is unique in providing the bioMérieux Scan RDI™ Rapid Microbial Detection Protocol. Eagle Analytical follows USP protocols for all microbiological and potency testing. Accurate compositional analysis is performed using HPLC systems with USP or other certified reference standards. Online laboratory reports are available, and lab results are archived for easy retrieval. Other tests as well as rush services are available and, as always, Eagle works with its customers to identify solutions when preparations are out of specification.

Specialized QA/QC Testing for the Compounding Pharmacist

  • Dedicated to the unique needs of compounding
  • Testing to USP and other certified standards
  • Modern state-of-the-art laboratory, cleanroom and instrumentation
  • Microbial Detection using the bioMérieux ScanRDI™ Protocol
  • USP <71> Membrane Filtration Test
  • USP <85> Bacterial Endotoxin Testing
  • USP <51> Antimicrobial Effectiveness Test
  • Potency to USP protocols for accurate compositional analysis performed using HPLC systems
  • Online laboratory reports available

Testing Services Offered

  • Rapid ScanRDI™ Bacteria, Mold, and Fungal Test
  • Sterility - Bacteria, Mold, and Fungal Test
  • Bacterial Endotoxins
  • Potency
  • Potency Over Time Studies to Determine Beyond-Use Dating of Compounded Preparations
  • Utilizing Stability Indicating Assays
  • Other testsas well as rush services are available

Visit our website below for details regarding samples sizes required for analysis and a sample submission form.

eagle analytical quality control pharmacy compounding Quality Assurance compound analysis pharmacist checking and testing medications. pcca analytical testing and quality control, QA/QC testing for compounding pharmacists



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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

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:

Read More Fall 2016 Edition | Community - Specialty - LTC

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

Perorate ® 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.

Read More Winter 2015 Edition | Health System - Infusion

Offer Personalized Medicine to Your Patients Through Pharmacogenetic Testing With Harmonyx

Harmony Diagnostics is a CAP-accredited and CLIA-certified automated genetic testing laboratory. Our program helps pharmacists provide better treatment and increased peace of mind for patients. After all, each patient is unique - and their treatment should reflect their own needs.

Read More Winter 2015 Edition | Community - Specialty - LTC

Eagle Analytical Offers Three Steps to Designing a Quality Control Potency Testing Program

Step one you can implement right now. Get your free copy of this article, which includes all three steps, at bit.ly/testing-with-eagle.

Read More Winter 2015 Edition | Community - Specialty - LTC

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

Rapid Endotoxin Testing - Pyrosate Kit by Associates of Cape Cod

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 Summer 2015 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 Summer 2014 Edition | Health System - Infusion

USP BET Compliant Endotoxin Testing for Compounding Pharmacies by Associates of Cape Cod, Inc.

Associates of Cape Cod, Inc. (ACC) is an industry innovator and global supplier of endotoxin and glucan detection products and services.

Read More Fall 2013 Edition | Community - Specialty - LTC

USP <797> Compliant Endotoxin Testing Solution for Compounding Pharmacists

Associates of Cape Cod, Inc. (ACC) is an industry innovator and global supplier of endotoxin and glucan detection products and services.

Read More Spring 2013 Edition | Community - Specialty - LTC
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Associates of Cape Cod Inc.

Specialists in endotoxin and glucan detection

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Front Range Labs

Front Range Labs has the staff, technology, and knowledge to take care of all your quality control needs

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Associates of Cape Cod

Our worldwide headquarters in East Falmouth, MA with ISO 13485:2003 certified, FDA Inspected and DEA Licensed laboratories and our Beacon Diagnostics™ laboratory is CLIA-certified. We also have offices in the UK and Germany and distribution in over 80 countries.

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Associates of Cape Cod

Why Test For Endotoxin? USP <797> requires that Compounding Pharmacists test certain high risk Compounded Sterile Preparations (CSPs). What Are Your Options? Either send out to a contract lab, or test in-house. Associates of Cape Cod's Pyros Kinetix® Flex Endotoxin Detection System provides a cost-effective, in-house endotoxin testing solution.

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Associates of Cape Cod

Why Test For Endotoxin? USP <797> requires that Compounding Pharmacists test certain high risk Compounded Sterile Preparations (CSPs). What Are Your Options? Either send out to a contract lab, or test in-house. Associates of Cape Cod's Pyros Kinetix® Flex Endotoxin Detection System provides a cost-effective, in-house endotoxin testing solution. Compliance: Meets USP requirements, Cost-Effective: Significant cost savings available, Rapid Turn-Around: Results possible in under 60 minutes

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Market Buzz

Pyrosate® Rapid FDA licensed Endotoxin Detection Kit

Associates of Cape Cod, Inc., (ACC) is pleased to introduce a new, FDA licensed version of our rapid endotoxin detection kit, Pyrosate®. Pyrosate® is well suited for performing endotoxin assays in full compliance with the Bacterial Endotoxins Test, USP chapter <85>. 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 easy to follow, step-by-step illustrated instructions allow the user to set up assays within minutes.

Press Release: Rapid FDA Licensed Endotoxin Detection Kit

Associates of Cape Cod, Inc., (ACC) is pleased to introduce a new, FDA licensed version of our rapid endotoxin detection kit, Pyrosate®. Pyrosate® is well suited for performing endotoxin assays in full compliance with the Bacterial Endotoxins Test, USP chapter <85>.

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