Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in method developement, bacterial endotoxin testing (BET), and glucan contamination. With the most extensive experience of any endotoxin testing laboratory in the world, CTS is GMP compliant, ISO registered, and licensed by the US Drug Enforcement Agency (DEA) as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with US Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or Japanese Pharmacopoeia (JP), depending on your specifications.
In addition to routine testing, CTS has extensive expertise and the ability to customize endotoxin testing to individual client needs, develop methods for difficult samples and devices, transfer BET test methods, and design and produce custom depyrogenation controls for oven validations.
CTS has experience with the following sample types:
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Pharmaceutical drugs, including Class II controlled substances, compounded pharmaceuticals, and anticancer drugs
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Medical devices
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Biological materials including whole blood, plasma, and bone
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In vitro fertilization solutions
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Dialysate
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Water
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Air quality samples
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Veterinary products
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Cosmetics
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Food products
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Vaccines
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Raw raterials
CTS qualifications include a GMP-compliant laboratory, ISO 13485:2003 registered, FDA inspected, and DEA Licensed.
Test methods performed at CTS:
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Chromogenic — color formation used to quantitate endotoxin (maximum sensitivity 0.001 EU/mL) and glucans
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Turbidimetric — the most sensitive turbidimetric endotoxin test available in the industry (maximum sensitivity 0.001 EU/mL)
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Gel-clot — the original Limulus amoebacyte lysate (LAL) assay and the method of reference in most reference manuals (maximum sensitivity 0.03 EU/mL).
Product Testing: Testing for endotoxin is performed at many steps in the manufacture of drugs and medical devices. Endotoxin testing is required for the release of finished product. Testing for endotoxins is also frequently performed to assess raw materials, in-process materials, and vendors, as well as for projects and components in research and development. Endotoxin testing is often a component of investigations into product-quality issues.
Raw Materials Testing: Raw materials can be tested as part of a traditional quality control (QC) program or process analytical technology (PAT). Identifying the amount of endotoxin in raw materials helps highlight process modifications that can improve the final product. Matching results from raw materials and final product can yield the contribution of each raw material to the endotoxin content of the final product and facilitate improvements in quality during production. Some raw materials should have endotoxin limits established and confirmed to determine if a batch can be accepted from a vendor.
Custom ServicesMethod Development: Some samples or devices interfere with BET, so a method must be developed to enable performing a valid test for endotoxin. CTS will determine how best to prepare each sample for testing.
Method Transfer: Many companies have sufficient testing volume to justify performing the assay in house. CTS works with companies to develop and optimize methods to test their products. CTS also helps customers convert from one methodology to another: e.g., from testing by the gel-clot method to chromogenic or turbidimetric assays. The methods developed by CTS are then transferred to you for use in your own QC laboratories. Your company gets the assurance that the method will work well with your products.
Custom Depyrogenation Controls: CTS will make custom depyrogenation controls using the same items normally processed in your oven and provide a certificate of analysis for the articles. The controls are then used to demonstrate at least a three-log reduction by your oven cycle. CTS can also test the depyrogenated items to verify your oven-cycle performance.
Author Details
Vann Jones is Marketing Manager at Associates of Cape Cod,® Inc. Contract Test Service (CTS), 124 Bernard E. Saint Jean Drive, East Falmouth, MA 02536-4445; 1-888-395–2221 ext. 2254 or 1-508-540– 3444, fax 1-508-540–2016;