RE: RE: RE: RE: RE: RE: Cytotoxic Drug Substance Contribution from NH ESWARA PRASAD written on 9/29/2008 at 19:03
Original contribution: RE: RE: RE: RE: RE: Cytotoxic Drug Substance written by JD Mallet on 9/24/2008 at 15:00) Dear Kniti.
Containment facility and Isolators should be used for the cytotoxic,steriod molecules,harmones and highly potent drugs. The conainement shall be decided based on the OEL(Occupational exposure limits)/PBECL ( Performance based exposeure control limit).Pl.refer
"AMERICAN INDUSTRIAL HYGIENE ASSOCIATION JOURNAL 57:3342 (1996)".
For the common materials the regualar warehouse can be used.But the raw materials which are cytotoxic and highly potent in nature should be handled separately and the sampling and dispensing should be done in the ISOLATOR.
We should not manufacture the cytotoxic,steriod molecules,harmones and highly potent drugs in the same facility. Dedicated facilities are required for each cateogory.
Hope this will clear your doubts.
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