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Airflow direction and visualization test

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  1.1.         Airflow direction test and visualization The purpose of this test is to confirm either the airflow direction or airflow pattern or both in regard to the design and performance specifications. If required, spatial characteristics of airflow in the installation may also be confirmed. Procedures for this test are given in ISO- 14644 . 1.1.1.   Testing schedule for optional tests In addition to the normative tests specified in  ISO- 14644  , optional tests, such as those listed in Table A.1, may be included within the testing plan. Table 1 : Schedule of optional tests   Test parameter Class Suggested maximum time interval Test procedure Airflow visualization All classes 24 months ISO 14644-3:—, clause B.7 1.1.2.   Principle The purpose of airflow direction test and visualization is to confirm that the airflow direction and its uniformity conform to the design and performance sp
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PRODUCT STABILITY TEST

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  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 ° C, 5.        Accelerated aging temperature (T AA )= 55 ° C 6.        The test duration is calculated using the Q 10 , T RT , and T AA . Time required for
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Microbiological Test Required to Product for Sterilization

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  BET TEST: Endotoxin Testing (LAL) Lipopolysaccharides (LPS) are bacterial endotoxins and present in Gram-negative bacterial cell walls known to cause fevers and diseases. Endotoxin testing of medical devices manufactured, and pharmaceuticals produced is necessary to ensure that the product is endotoxin free. It required on various stages of product life cycle: Bulk Lot Release Testing Final Product Release Testing Raw Material Testing Limulous amoebocyte lysate (LAL)  is a test performed as this is based in the biology of the horseshoe crab which produces LAL enzymes in blood cells to bind and inactivate endotoxin from invading bacteria. This method is accepted worldwide. USP <85> requires testing of a production lot for the presence of bacterial endotoxin. LAL - endotoxin tests with a variety of assay options including: Quantitative and qualitative testing Gel-clot method (LAL test) Chromogenic methods (USP Chromogenic) The Gel-clot met
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Microbiological Test Required to product for sterilization

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  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 will collect onto the surface of a 0.45-micron pore size filter. This filter is segmented and transferred to approp
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MICROBIAL LOAD TEST: Bioburden Test

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  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>.
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Biological Indicator – Sterility Testing

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      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/AMMI/ISO 11138 s
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Test required for Clean rooms testing to demonstrate compliance with ISO-14644

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  TESTING PART 1 DEMONSTARTION OF CONTINEOUS COMPLIANCE FOR CLEAN ROOMS   PHYSICAL ENVIRONMENTAL MONITORING 1.   Physical Testing (General) Compliance with air cleanliness (ISO Classes) requirements specified by the ISO14644 is verified by performing specified testing procedure and by providing specified documentation of the result and conditions of testing, as agreed upon by client and service supplier (the third party) and internal testing labs.   The reference test method for demonstration of compliance is as per ISO-14644-1, ISO 14644-2 & ISO 14644-3. An alternative method having comparable accuracy may be specified, although if no method is specified or agreed upon, the reference method shall be used. For Clean rooms, clean zones & clean air devices existing at any company, following physical tests are included for demonstration of compliance. 1.1.      Airborne particle count This test is performed to determine air cleanliness class (classification test
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