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Subject:
From:
"Robbi, Chiara" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 19 Apr 2023 08:17:09 +0000
Content-Type:
text/plain
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text/plain (89 lines)
Dear all,

in this period I am involved in a revamping and construction project of a new micro laboratory.
For this reason I would need to receive information and clarifications regarding the minimum criteria for a GMP laboratory.
I have some questions, for example:
-should the wall and floor surfaces of the rooms be "pharmaceutical" like in a Class D or not? It is sufficient to have cleanable and disinfectable surfaces?
-for the treatment of the air must an HVAC be installed or should I consider it as nice to have?
-should an HVAC be installed for the treatment of the air or should I consider it as nice to have?

Other than in Annex 1, where can I find information and indications on this subject: guideline or other document?

Thanks so much for your help and any suggestions will be appreciated

Chiara



-----Messaggio originale-----
Da: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> Per conto di Donald English
Inviato: mercoledì 19 aprile 2023 02:31
A: [log in to unmask]
Oggetto: [PMFLIST] Washington House Bill 1047-Formaldehydye Releasing Preservatives

Caution: This email message originated from outside of the organization. DO NOT CLICK on links or open attachments unless you recognize the sender and know the content is safe.  If you think it is suspicious, please report as suspicious. 

Dear all,

For your information, the Washington State Senate and House passed Washington House Bill 1047.  If this bill signed into law, it would ban the usage of formaldehyde-releasing preservatives in cosmetics such as DMDM hydantoin, Imidazolidinyl urea, Diazolidinyl urea, and Sodium hydroxymethylglycinate by January 2027.  They are banned due to them being considered as toxic chemicals.  By this logic, wouldn’t all traditional preservatives and multi-functional ingredients that have antimicrobial activity be considered as toxic chemicals because they kill microorganisms?

It seems that this trend of states in banning the usage of traditional preservatives in cosmetic products is troubling.  Until products are recalled due to the presence of microbial contamination due to inadequate preservation and causing harm to consumers, this trend of states banning the usage of traditional preservatives will seem to continue since there is no federal positive preservative list of allowed preservatives that can be used in cosmetics that are sold within the United States.  Furthermore, it seems that the cosmetic industry is sleeping at the switch again on this issue in which additional states are now banning the usage of certain preservatives in cosmetic products due to toxicity concerns.  Banning of certain chemicals in cosmetic products should be based upon science and not fear.  I will admit that I do not know how this can be accomplished so that proper decisions on the safety of preservative ingredients can be made at the state level.

Don

Donald J. English Microbiological Quality Consulting LLC Florham Park, New Jersey 07932

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