2 Comments

  1. Hello,
    my name is Nina. Thank you for excellent article. I am working in microbiology lab. We use autoclaves for sterilization of nutrient media and aome plastic (tips for autometed pippets). Autoclaves have been qualified every year (vacuum test, temperature mapping, BI checikg). We had audit two years ago and auditor asked for quality of pure steam. What is your opinion about this? Is this mandatory requirements for laboratoy autoclave? Autoclaves are old about 17 years and we didnt ask in specification quality of pure steam. How can we explain in risk assesment that this tests are not mandatory for this kind of equipment.

    1. Glad to know that Nina! Regarding your question. Why do you Autoclave the components? To assure the sterility, right? If your steam itself isn’t pure, how you are going to prove that? That’s why the auditor might have asked about that. Mandatory is nothing unless you can justify other way round. But you need to establish the steam quality parameters. Anyhow. Don’t even think about explaining via risk assessment that the steam quality doesn’t matter. It matters with the very reason of you doing the autoclave. Hope this clarifies.

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