First off: Thanks in advance for your help and I hope this is remotely in the right section!
Situation: I’m looking to purchase a new autoclave which I will then help validate. My company will eventually market in both the US and Europe. For now, we are intending to just get an inexpensive, small (~60L chamber) benchtop autoclave because our intention is to autoclave:
A handful of In-Process Equipment (stainless steel tools, bottles) (by no means terminal sterilization)
Waste for Disposal
So I have a list of questions about how to satisfy both FDA and European Union standards:
In autoclaving simple tools and bottles used in a manufacturing process, does the autoclave then qualify as “Clinical”? (Much more strict validation tests, even though the load is just scissors and beakers, and not “medical devices.”? But oh well.)
Are we required to autoclave microbiology waste in an a dedicated autoclave (and hence need at least 2 autoclaves)?
Could someone point me in the direction of what European/USA guidances I need to follow? I am stumped about whether there is a separate set of guidances concerning benchtop steam sterilizers for this purpose.
Thank you so much. These questions have been tormenting me for the last 2 months!
Using an autoclave for different loads is quite common practice. The autoclave is a method of applying a heating cooling program to your intended item. The verification that the program has worked is the proof that is required by regulators.
So you must know the condition of the item prior to autoclaving and then post autoclaving.
Once you have worked out a program that gives you the correct post autoclave sterility standard; you validate it by running three batches through it and verifying that your product has been sterilised as expected. You then validate this process so you can demonstrate that it can be successfully replicated.
Bench top machines can be difficult since some generate there own steam. This steam is of unknown quality (dryness/superheat/none condensable gases). So you must err on the safe side in establishing your cycle temperature and times.
There are more details on our site at:-
I understand the theory of autoclave validation, but what I am caught up on is as follows.
By using a benchtop autoclave for non-medical-device goods (but instead simple tools that are used in the process of making product that later has patient contact), which set of guidances do we need to follow: Those for laboratory sterilizers or those for clinical sterilizers? And what guidance docs concern benchtop size sterilizers for that purpose?
And my question (2) relates to this quote from Chapter 3 HTM2010 part 2:
"a. clinical sterilizers are designed to process medical devices or medicinal
products;
b. laboratory sterilizers are designed to process laboratory goods and
materials that are neither medical devices nor medicinal products and are
not intended for use in the clinical care of patients.
3.3 The operation of sterilizers in the two categories should be kept strictly
separate. Loads intended for processing in a clinical sterilizer should not be put into a laboratory sterilizer and vice versa."
So I suppose it is dependent on the first question.