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.
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.
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 firstname.lastname@example.org and I will send it to you