Pharmaceuticals/airlocks desing

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Question
QUESTION: Dear Michael:
Can you help me with the desing of the airlocks for personal entrence to hormonal manufacturing áreas of solid products.
Thank you very much.
Regards

ANSWER: Dear Ronald:

To answer your question properly, I need to know whether:

a. the hormone production section is part of a facility that also manufactures other non-hormone products, or not;

b. whether the airlock divides the hormone area from the non-hormone area; or it is within the hormone area.


---------- FOLLOW-UP ----------

QUESTION: Dear Michael.
Thank you very much for your aswer. In response to your questions.

a.The hormone production is a new facility. Distance 70 meters from the non-hormone products. This new facility is for oral solid products and injectable.

b.The airlocks in the hormone production áreas, are for entrance-exit changing room and materials air lock. Is correct use this arilocks or passbox in each área (granulation,mixing,compression,coating,injectable solutions manufacturinig, etc) what is the best desing for each.

Best regard

Ronald

Answer
Airlock Design
Airlock Design  
Ronald:

The WHO has published an excellent guideline titled:

Technical Report Series, No. 961, 2011 - Annex 5 - Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning systems for non-sterile pharmaceutical dosage forms. You can download this document from the WHO website.

Section 4.7.11, discusses airlock design. A "bubble airlock" will meet your needs.

If you cannot find this guideline on the WHO website, please contact me at manisfeld@globephrm.org and I will send it to you

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Michael Anisfeld

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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

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