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Microbiological Testing Lab - Layout & Standards

mpfizer

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#1
Hi,
We are an Orthopedic implant manufacturer , we have trauma and joints in our product range... would like to know if there are any standards ISO / ASTM for setting up microbiological testing lab for environmental monitoring of class 10000 clean room , DM/ RO water testing and sterility testing of gamma irradiated products.
Is there a standard template for layout of lab?
How many AHU's are required and why?
How many rooms required ie sterility testing , media preparation, media washing, cooling zone,Incubation etc...
Should MLT and Sterility testing rooms have different AHU... should airlocks have a different AHU ?
Should there be separate airlocks for entry to sterility testing room and MLT room also can the exist for both rooms be same as that used for entry?

Any help would be highly appreciated.

Thanks
michelle
 
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