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
My company has an UV box that where use to bass eye drops containers, the eye drops containers is already sterile with gamma radiation, what we doing is just spray alcohol on the outer plastic pocket that contain the eye dropps then pass it to the clean area after placing in the UV box for 20 minute.
Is the method we use is correct, if yes how could i make the correct qualification for them.
ANSWER: Ahmad:
Hate to tell you this, but the UV box is a total waste of time. UV only works in direct line of sight from the lapm source - so the underside of the bag gets no UV treatment and hence is not sterilized. We have stopped using this technology in the US and Europe for at least 20 years.
Better is to get your containers gamma irradiated in double bags. Then sanitize the pass-through, and in the pass-through remove the outer bag, bringing only the inner gamma irradiated bag (with the containers) into the clean room.
Hope this helps
---------- FOLLOW-UP ----------
QUESTION: Dear Sir
Thanks for your reply, i want to clarify some issues about the method we use:
1- The plastic pocket that containers the eye drops containers and nozzles "sterile by gamma radiation" is exposed to direct UV light can pass it to the eye drops containers.
2- You mention that we have to sanitize the pass through, does we have to use a another method instead of using 70% alcohol or this method is sufficient.
3-In the pass through does we have to make an air circulation " like unidirectional air flow".
4-I know that the UV is not from the accredited method for sterilization, is that for there is no need for exposing our product to UV radiation "useless".
Answer 1. sorry but I do not understand your comment - pls rephrase it;
2. you can use 70% isopropanol as long as it has been irradiated or sterile filtered to remove the spores that it contains
3. no passthroughs do not need air circulation ... BUT ... there must be positive pressure differential between the cleanroom side and the dirty side.
4. as I explained using UV for sterilization in this situation is pointless, as UV only works in "light of sight" and there are many surfaces that are shaded from the UV lamp.
