Microbiology.com

  Purpose: The objective of the test is determination of shelf life by using accelerated aging test method according to ASTM 1980 and ISO 11607. Materials: Test Sample, Room or Cabinet, Control Apparatus, Hygrometer, Thermometer Test Method: 1.        Select the Rate Reaction Coefficient (Q10) value.  2.        The desired shelf life(Retention Time (RT)) of the test sample it can be 1, 2 upto 5 years depend on the sample. 3.        Define aging test time intervals, including time zero using the following equations:   AAF = Q 10 [(T AA -T RT )/10]   Where:   T AA ≡ accelerated aging temperature ( ° C), and T RT ≡ ambient temperature ( ° C).   AAF= 2 [55-25/10] AAF= 8 Accelerated Aging Time (AAT) = Desired (RT)/AAF AAT   = 45 Days   4.        Test conditions, room temperature (T RT ). TRT = 25 ...

  Sterility test: As per USP 71 Sterility testing required for pharmaceutical products, medical devices, Cosmetics, and food items including liquids and water samples. Sterility testing is required during the sterilization validation process as well as for routine release testing.   Types of USP Sterility Methods There are three USP Sterility Methods: ·         Membrane Filtration ·         Direct Transfer (Product Immersion) ·         Product Flush/Extract/Rinsing Membrane Filtration Method for Sterility Testing The Membrane Filtration Sterility Test is the method of choice for many medical devices, food, cosmetics and pharmaceutical products. An appropriate use of this test is for devices that contain a preservative and are bacteriostatic and/or fungistatic under the direct transfer method. With membrane filtration, the concept is that the microorganisms w...

  Bioburden OR Microbial load testing (MLT) is a regulatory requirement and is critical for process development of biological, pharmaceutical, surgical, and dental and other medical devices i.e., catheters and stents along with systems. It is an important test for raw material, semi-finished and finished product. It can provide an accurate basis for calculating effective sterilization doses and will provide the quantity of viable microorganisms in or on product or raw material before sterilization. Bioburden testing is applicable for: Lot Release Testing Final Product Testing Raw Material Testing Semi-finished Product Testing Contact us  about your bioburden testing needs. Microbiology.com can provide all these services in accordance with ISO 11737, USP <61>, USP <62>.

      Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. The test is qualitative which yields results of either growth or no growth of the appropriate indicator organism. The test is performed on BIs subjected to different types of sterilization such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide and ozone, as well as other novel processes. Both traditional BIs and self-contained BIs may be tested. This test is typically performed during validation as well as during routine production as a LOT release test. BI testing and sample requirements are in numerous standards including USP <55>, the ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 14161, and ANSI/AM...