Aseptic areas services

To the extent possible, equipment fittings and services are designed and installed so that operations, maintenance and repairs can be earned out outside the dean and aseptic areas. 

Aseptic Area A room or suite of rooms or special area within a dean area, designed, constructed, serviced and used with the intention of preventing microbial contamination of the product... 

Terminal HEPAs should be located in the air supply ducts as close as possible to their point-of-use exit grilles. For aseptic filling rooms they should be specified at 99.997% efficiency. They may be set in one of two types of housing, front-withdrawal or back-withdrawal, depending on the mechanism for removal and replacement. Back-withdrawal HEPAs can be removed from outside the protected environment front-withdrawal types have to be removed via the protected environment itself. Neither type is suited to removal and replacement with the area remaining sufAciently protected for operation, but front-withdrawal is preferable because it leaves the duct work intact and not subject to contaminaAon from unprotected service voids during removal. 

In Fig. 10, two solid dosage form aseptic filling rooms share common gray areas. Once again the flow of vials from empty to full follows a U-shaped track, and again there are two major gray areas. Within each gray area the same personnel can service both lines with vials or closures. 

The environment to which the excipient may be exposed should be similar to that used in the manufacture of the final dosage form. This is especially true in the case of excipients intended for parenterals. For example, controlled areas may need to be established along with appropriate air quality classifications. Such areas should be serviced by suitable air handling systems and there should be adequate environmental monitoring programs. Any manipulation of sterile excipient post-sterilization must be performed as an aseptic process, including the utilization of Class 100 air and other aseptic controls. 

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