Aseptic areas entry

Environmental cleanliness and hygiene 3.2.2 Entry to aseptic areas... 

Articles which are to he discharged from the clean room (or elsewhere) to the aseptic area must he sterilized. To achieve this they should be transferred via a double-ended sterilizer (i.e. with a door at each end). If it is not possible, or required, that they be discharged directly to the aseptic area, they should be (i) double-wrapped before sterilization (ii) transferred immediately after sterilization to a clean environment until required and (iii) transferred from this clean environment via a double-doored hatch (where the outer wrapping is removed) to the aseptic area (where the inner wrapper is removed at the workbench). Hatchways and sterilizers should be arranged so that only one side of the entry into an aseptic area may be opened at any one time. Solutions manufactured in the clean room may be brought into the aseptic area through a sterile 0.22-/im bacteria-proof membrane filter. 

Commence work Fig. 21.4 Entry into aseptic area. 

Entry to a clean or aseptic area should be through a changing room fitted with interlocking doors this acts as an airlock to prevent influx of air from outside. This route is for personnel only, not for the transfer of materials and equipment. Staff entering the changing room should already be clad in the standard factory or hospital protective clothing. 

The changing procedure for entry to an aseptic area is described in section 3.2.2. 

To prevent dust from collecting, all ledges, doors and windows should fit flush with walls. Doors should be well fitting to reduce the entry of microorganisms, except where a positive air pressure is maintained. Ideally, all windows in manufacturing areas should serve only to permit light entry and should not be used for ventilation. In areas where aseptic operations are carried out, an adequate air-control system, other than windows, is essential. 

For the manufacture of sterile drugs, separate enclosed areas specifically designated for the purpose shall be provided. These areas shall be provided with air locks for entry and shall be essentially dust free and ventilated with and air supply. For all areas where aseptic manufacture has to be carried out air supply shall be filtered through bacteria retaining filters (HEPA filters) and shall be a pressure higher that the adjacent areas. The filters shall be checked for performance on installation and periodically thereafter, and records thereon shall be maintained. 

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