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About Michael Anisfeld
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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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You are here:  Experts > Health/Fitness > Pharmacology > Pharmaceuticals > Qualification of Autoclave

Pharmaceuticals - Qualification of Autoclave


Expert: Michael Anisfeld - 10/27/2006

Question
USP general Chapters for microbiological testing requires to perfrom temperature mapping of the autoclave to be used for media sterization. The autoclave we have does not a port to place thermocouples in it for temperature monitoring. Can you suggest an alternate strategy to verify that the autoclave is suitable for the intended use without the use of temperature monitoring? Thanks

Answer
Three alternatives are available for temperature profiling "old" 'claves:

a. purchase a set of radio transmitting probes, which will transmit the temperatures through the vessel wall during the study;

b. purchase some mini-data loggers, and after the runs download the data, and analyze;

c. purchase a "new" 'clave (and this is a serious option, which may end up begin the cheapest option)

Hope this helps,
Mike

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