Endotoxin Testing: Methods, USP <85> Requirements, and Industry Implications
Endotoxin Testing performs a crucial role in the pharmaceutical and medical device industries for ensuring product safety and regulatory compliance.
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Endotoxin Testing performs a crucial role in the pharmaceutical and medical device industries for ensuring product safety and regulatory compliance.
The Therapeutic Goods Administration, or TGA is a division of the Australian Government Department of Health. The TGA is responsible for regulating therapeutic goods, like prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Medical device irritation testing is a highly regulated industry (read more about medical device cleaning and validation) with requirements for cleaning, sterilization, reprocessing, and irritation testing. Similar to biocompatibility, irritation testing determines...
Biocompatibility testing is commonly done for medical devices with testing ranging from screening of new materials to safety evaluations. The term "biocompatibility" refers to the compatibility of materials with living tissue. Biocompatibility testing is required...
Medical device testing is of major importance to companies and manufacturers as a device failure can cost the company hundreds of thousands of dollars. Medical device testing helps to ensure kinks or vulnerabilities are worked out before the device reaches the...
Looking for medical device testing? On March 12, 2015, the US Food and Drug Administration released a final guidance for medical device reprocessing entitled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” This guidance was...
Sterility assurance level, or SAL, is the chance that although something has been through the process of sterilization, there is still the potential the item is nonsterile as it is impossible to prove that every harmful organism has been destroyed. The sterility...
ISO 10993 medical device biocompatibility testing is performed to observe how compatible a device is with living tissue. To be considered biocompatible, a device needs to cause no local or systemic response. Biocompatibility is determined through a series of tests...
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