EXPERTS IN BACTERIAL ENDOTOXIN TESTING
In addition to routine testing, CTS has extensive expertise and the ability to: • Perform Low Endotoxin Recovery (LER) studies/protocols • Customize endotoxin testing to individual client needs • Develop methods for difficult samples • Develop and/or transfer BET test methods • Design and produce custom depyrogenation controls for oven validations Examples of sample types with which CTS has experience: • Pharmaceutical Drugs, including Class II controlled substances, compounded pharmaceuticals and anti-cancer drugs • Liposomal Drug Products • Medical Devices • Veterinary Products • Oligonucleotide Drug Products • Dialysate • Water • Air Quality Samples • Filters • Cosmetics • Food Products • Vaccines • Tobacco Products
CTS Qualifications • GMP Compliant Laboratory (FDA and 2003/94/EC) • ISO 13485:2016 Registered
• FDA Inspected • DEA Licensed Test Methods
• Chromogenic - Color formation is used to quantitate endotoxin (maximum sensitivity 0.001 EU/mL) and glucans • Turbidimetric - The most sensitive turbidimetric endotoxin test available in the industry (maximum sensitivity 0.001 EU/mL) • Gel-clot - The original BET assay and the method of reference in most reference manuals (maximum sensitivity 0.03 EU/mL) • Glucatell ® - Glucan testing to quantitate the amount of (1 g 3)- b - D -Glucans in samples
• Machine Oils • Raw Materials • Clinical Research Samples
CTS offers fast processing for routine samples, accurate and reliable test results along with full client confiden- tiality. After sample test results are reviewed, a written report is sent to the client. The client also receives an electronic copy of the report as a PDF.
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