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Category: General Routine 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 General Routine 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.
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.
Microbial Identification USP 71, ISO 11737
Identifying microorganisms can be a very difficult task. They are not all alike. There is not one system that can identify all microorganisms. Every system has its strong points and weaknesses. Sometimes additional testing is needed because one system failed to name an organism. Other times additional testing is needed to confirm that the name given is correct Nelson Laboratories has worked hard to put together different systems that will complement each other and work together to give the best IDs. These tests include the Vitek® 2 Compact identification system, Gram Stain, mold identification, MIDI Identification system, API strips and other biochemical tests.
An additional Microbial Id's form is recommended when submitting samples for this study.