AboutMichael Anisfeld Expertise 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
Experience
Past/Present clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question QUESTION: As it is well known, Uv radiations are not 100 % effective, if used alone as surfaces sanitizing agents through pass boxes to clean areas.
Therefore, in our company it has been decided to use chemical sanitizing agents (peracetic acid and Hydrogen peroxide solution)for the materials surfaces plus UV radiation and air flow to sanitize the pass box inner environment. Our procedure is the following: sanitization of the material (possibly in double bag gamma radiated)prior to put the material itself in the pass box for a period as long as the contact time validated for the sanitizing agent. During this period the UV lamps and the airflow are kept active in order to sanitize the pass box surfaces and the air. Does it make sense to you?
Can you suggest some references about this issue?
Thanks
ANSWER: Dear Frederica:
Your proposal is "interesting" and very strange.
If the materials are double bagged in sterile packaging, then typically they are placed in the "pass through", and when it is time to use them, the inner door of the pass-through opened, the outer of the double bags removed, and the material in its inner bag brought into the clean room, with the outer bag discarded.
It has been years since I have seen UV lamps installed in a pass-through, and even though I audit about 15 sterile product manufacturers annually, in the past several years I can only remember one instance of folks having HEPA filtered air in the pass-through (why would you need it? the doors are closed, the material is double bagged).
---------- FOLLOW-UP ----------
QUESTION: Thanks for your prompt reply.
Last question: the pass box is located between a C grade room and a B grade room. Provided that your material is ok because of the double bag, how can you be sure that the air inside the pass box and its innersurfaces have a level of contamination below the acceptable limits for B grade. I mean, the door on the C grade room has to be open in order to put the material in. Are the UV rays alone effective enough to decontaminate the environment? You don't see the point in using airflow too, right?
Could you tell me which approach you would follow?
Thanks again
Federica
Answer The pass-through is a closed box. When you open it to place material in from the "C" (dirty) side, spray sterile 70% isopropanol on walls and with sterile cloth wipe all pass-through surfaces, then place double baggie inside.
In the US and Europe I do not know anyone with UV lights or air flow in pass-throughs.
