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Sterility Testing Service


Creative Biogene provides a sterility testing service for biologics, pharmaceuticals and medical devices in accordance...

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Sterility Testing Service

Creative Biogene provides a sterility testing service for biologics, pharmaceuticals and medical devices in accordance to the guideline of USP, EP, JP and BP. With leading-edge clean room and procedure, our experienced scientists will provide convincing and reliable sterility testing services. In addition, our scientist team will assist you in determining how and when to test your product in concordance to the governing standards for sterility test. And they will work closely with you in the whole process.

Sterility test is a fundamental part of every sterilization validation. And it is a significant quality control procedure for substances or preparations that are required to be sterile. In order to eliminate false positive results, sterility testing is executed in an aseptic processing environment and conducted by trained and experienced personnel. The working room must test for viable bacterial and fungal organisms as well as particulate testing. The testing area should meet the ISO class 5 particulate control requirements.

Sterility Testing Service

Creative Biogene offers a high quality sterility testing service under an exacting standard procedure. Several methods are available for sterility testing, including direct inoculation, membrane filtration and bacteriostasis / fungistasis test. The first two methods are used to detect if there are contaminating microorganisms in the samples, while the last test is considered as a tool for detecting the presence of antimicrobial properties. All assays in the determination are useful. After sterility testing, we will provide a reliable sterility test result that can indicate the quality of samples. Custom testing service is also available.

Creative Biogene offers sterility testing for:

  1. Master Cell Bank and Working Cell Bank;
  2. Final Bulk;
  3. Unprocessed Bulk Harvest;
  4. Other Samples.

For more information, please contact us at any time.

Reference:

  1. World Health Organization, Testing for Sterility: Final text for revision of the International Pharmacopoeia, The International Pharmacopoeia (4th Edition), 2012.

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