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: Dear concerned,
I would like to know about the "material Of Construction" (MOC) of FBD bag.
Thank you very much,
Nimesh
ANSWER: Ususally PVC, but the trick in the selection of the plasticizers, opacifiers, etc. mixed in with the PVC resin.
---------- FOLLOW-UP ----------
QUESTION: Thanks Michael,
I have further questions. (1) Should we require to Analyze the bag OR vendor certificate is sufficient in Audit view point? (2)I shall be very thankful to you if you can provide any specification, literature, guidance document how to analyze the bag!
thank you very much
Answer You must, I repeat MUST, personally audit the bag fabricator - and take someone with you who knows the technology (I have been involved with FBD's for over 20 years and can assist, but I charge - contact me off-line at consulting@globepharm.org).
As for the specifications, etc., you should not need to analyze the bag, but you must have faith that the supplier's COA is accurate. Each manufacturer's bag is different with different ingredients, so I cannot provide content details.
