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About USPClass VI Testing &
Testing Methods For Plastics
What is USPClass Testing?
USP Class testing is one of the most
common methods of testing to determine bio-compatibility of
materials. There are six classes, VI being the most rigorous.
Class VI testing is aimed to certify that there are no harmful
reactions or long-term bodily effects caused by chemicals that
leach out of plastic materials. USP Class Testing standards are
determined by the United States Pharmacopeia and National
Formulary (USP-NF), the organization responsible for the quality
and safety of medical devices and foods. Class testing is
frequently conducted on plastic materials that come in contact
with injectable drugs and other fluids found in various steps of
the drug manufacturing process.
USPClass VI Testing Methods
USP Class VI testing is conducted by
producing an extract of the product with different extraction
fluids, such as polyethylene glycol and vegetable oil, and
injecting it in specimen (rabbits and mice) in vivo (alive), to
observe the biological response to the extract. Testing is
commonly done as per USP<88>, which requires three types of
testing: systemic injection, intracutaneous, and implantation.
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Systemic Injection Test (Acute
Systemic Toxicity) : Test specimen are injected with the extract
intravenously and observed for 72 hours. The specimen are
monitored for any abnormal toxic reactivity. The scientist
determines the test as pass/fail.
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Intracutaneous Test : The purpose of
this test is to check for any local skin reactions. Test Specimen
are injected with the extract intracutaneously and observed for 72
hours. The reactions are scored and averaged.
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Implantation Test : Specimen are
implanted with the product material to observe the reaction of the
live tissue in direct contact with the product over a span of at
least 120 hours (5 days).
Ref :
https://www.tblplastics.com/usp-class-vi-testing/
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