My question is in regards to personal hygiene in the packaging or cleanroom. I have reviewed several CSD resources and have not found any standard stating that the use of cosmetic should not be permited, especially those which can shed particles, e.g. powder based cosmetic (face powder/mascara). What is your opinion? What does your hygiene plan say?
By the way, http://www.MviTraining.com/micron.video has a good preview for tutorial videos on Cleanroom standars for pharmaceutical and medical Industry.

Greetings from Josy Holdener

Dear Josy,

like you, I am not aware of any standard giving a statement on the use or ban of cosmetics which release particles to environment. There are thresholds for particles for pharmceutical clean rooms, and in those rooms every attempt has to be made to reduce the number of particles in the room or production area, but these standards do not neccessarily apply for CSSDs. In my experience, staff has always been very sensitive when it comes to restrictions which touch private life. I think, we should not invade into this area unless we are either confronted with an extreme situation (make-up like full war-paint) or we have good data or at least good theoretical (= scientifically based) reasons to do so.

I very much look forward to know different opinions.

Best regards
Peter

Prof. Dr. P. Heeg
Dept. of Hospital Infection Control
University of Tübingen, Germany

In the Annex 1 (Manufacture of sterile medicinal Products) of the EU Guide to Good Manufacturing Practice (Medicinal products for human and veterinary use) is under Personnel writen: "18. Wristwatches, make-up and jewellery should not be worn in clean areas."

Kurt Reinhard