Autoclaves Contribution from Stuart Allen written on 7/8/2008 at 14:54
From a regulatory point of view, what are the arguments for dedicating autoclaves to dirty and clean operations and what are the contamination issues? Are there any reference documents for this other than HTM 2010 document? Are there any compendial drivers? What do other companies do? Has anyone else written justification to go to one autoclave and if so what did it include? Do they monitor loads with biological indicators and how often?
The products we autoclave are standard oral solid dosage medicinal products
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