Aseptic Area Validation Procedures

To describe the procedure for the validation of aseptic area to prevent cross-contamination and demonstrate environmental control 

All concerned departmental managers and validation engineers are responsible for following the procedure. The quality assurance manager is responsible for SOP compliance. 

The controlled areas will be subjected to the following set of performance tests  

Air flow, volume, and distribution (also designated as post-balancing verification) 

The instruments used for these tests should be calibrated and included with the report. The tests will be performed at rest, dynamic, and stress conditions. 

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A concurrent intensive monitoring of air, surface, and personnel hygiene should be performed during all validation procedures within the aseptic area. For documentation use Attachment No. 1700.100(A). For template validation/ report refer to Attachment No. 1700.100(B). 

In general the quality control procedures for products obtained through biotechnology are very similar to those routinely used with traditional pharmaceutical products in areas such as raw material testing, documentation of process control, and aseptic processing. The fundamental difference is in the type of methods used, so as to determine the product s identity, uniformity, and purity. In the quality control of products obtained through recombinant DNA technology, it is necessary to employ validated tests for the final and intermediary products to ensure the elimination of undesirable impurities. 

For Aseptic Processing where disinfection is employed to further reduce the surface contamination level, the choice of disinfectants and the way that they are used should be described in a procedure, in addition, detergents, disinfectants and antiseptics should be supplied sterile, or be sterile-filtered or otherwise sterilised at the use-dilution, or be sterilised as a concentrate and diluted only with sterile water. Diluted disinfectants or antiseptics should not be stored. Containers should not be topped up. Disinfectants/detergents used should be validated and approved. When disinfectants are used, more than one type should be employed. Monitoring should be undertaken regularly to detect the development of resistant stains. Disinfectants and detergents used in Class 1 and 2 areas should be sterilised prior to use. 

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