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Category: Product Validation & Lot Release Testing
For testing pre- and post- sterilization of product, Nelson Laboratories, Inc. has a wide range of microbiological and analytical test services. Most routine quality control tests are started within 24 hours and preliminary results are available to assist the client with improving lead time on product.
Tests available for Product Validation & Lot Release Testing
Bioburden testing ANSI/AAMI/ISO 11737, ISO 11135, EN 1174
Bioburden testing is done to determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps before sterilization.
Limulus Amebocyte Lysate (LAL) USP 161, USP 28, USP 85, USP 797, AAMI ST72:2002, EP 2.6
The Limulus amebocyte lysate (LAL) test is in vitro assay for detection and quantitation of bacterial endotoxin. Validated test methods performed at Nelson Laboratories includes the gel clot technique and the kinetic turbidimetric and chromogenic (colorimetric) assays.
Bacteriostasis and Fungistasis test USP 71, USP 161, USP 797, EP2.6.1, JP14 54
This test is performed on a sterile product to determine if any inhibiting factors exist in the product which would invalidate a test for sterility. A sterility test is technically not valid unless this test has been performed on the product.
Product sterility- Cleanroom USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Samples are tested for sterility by placing them in growth media, incubating them for a minimum of fourteen days and checking them for evidence of microbial contamination. Samples are placed into the media using direct transfer or membrane filtration. To optimize aseptic transfer of samples into the test media, all testing is performed in a state of the art ISO class 5 cleanroom. Sterility tests must be validated by performing a Bacteriostasis/Fungistasis test.
Product sterility- Isolator USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Samples are tested for sterility by placing them in growth media, incubating them for a minimum of fourteen days and checking them for evidence of microbial contamination. Samples are placed into the media using direct transfer or membrane filtration. To optimize aseptic transfer of samples into the test media, all testing is performed in a state of the art ISO class 5 cleanroom. Sterility tests must be validated by performing a Bacteriostasis/Fungistasis test.
Particulate analysis USP 788, EN 45502, ISO 1135-4
This method includes procedures for removing, counting, and sizing particulate contaminants on/in medical devices, solutions, and other pharmaceuticals using the HIAC Royco Liquid Particle Counting System Model #9703 or a microscopic method. The light obscuration procedure is the first stage for testing particulate matter in injections. If the injection fails to meet the prescribed limits, it must be further tested using the microscopic procedure (stage 2) with its own set of test limits.