Cl. (a) was relettered as cl. (aa) by Act 13 of 1964 s. 2, (w.e.f. 15-9-1964).

9.1. Manufacture of sterile products shall be carried out only in areas under defined conditions.

9.2. Bulk raw materials shall be monitored for bio-burden periodically. Bio-burden of bulk solution prior to membrane filtration shall be monitored periodically and a limit of not more than 100 cfu per ml is recommended.

9.3 The time between the start of the preparation of the solution and its sterilization or filtration through a micro-organism retaining filter shall be minimized. There shall be a set maximum permissible time for each product that takes into account its composition and method of storage mentioned in the Master formula record.

9.4. Gases coming in contact with the sterile product shall be filtered through two 0.22 µ hydrophobic filters connected in-series. These filters shall be tested for integrity. Gas cylinders shall not be taken inside aseptic areas.

9.5. Washed containers shall be sterilized immediately before use. Sterilized containers, if not used within an established time, shall be rinsed with distilled or filtered purified water and re-sterilized.

9.6. Each lot of finished product shall be filled in one continuous operation. In each case, where one batch is filled in using more than one operation, each lot shall be tested separately for sterility and held separately till sterility test results are known.

9.7. Special care shall be exercised while filling products in powder form so as not to contaminate the environment during transfer of powder to filling machine-hopper.