Freeze drier validation

All production processes, such as ampoule washing and sterilization, solution filtration, equipment set-up and operation, sorting, and freeze-drier cleaning and operation, should be covered in detail in a procedure manual to ensure that all operations are understood as well as carried out properly and uniformly. Cleaning, sterilization, sterile filtration, filling, and aseptic processing operations must be validated. 

To describe the procedure for validation of the freeze drier to ensure it meets the installation, operational, and performance qualihcation criteria... 

Although spillages during product dispensing may contribute to ablation, the two hazards are quite different. Ablation can occur in the absence of spillage and will contaminate all internal surfaces of the freeze-drier. As discussed above, ablation is not associated solely with a poorly formulated product but should always be anticipated whenever pathogens or toxins are freeze-dried unless validated physical barriers are interposed between the product and the interior of the freeze-drier. 

Depth or screen filters find wide application for sterilising gases but their installation in freeze-driers is often completed without adequate validation, resulting in the use of inappropriate or incorrectly positioned filters. 

In one respect, decontamination following freeze-drying of a known pathogen is a more simple procedure than general decontamination of a freeze-drier for pharmaceutical processing since the nature of the pathogen or toxin will be known and its sensitivity to a particular biocide can be experimentally validated. 

As part of a planned, preventative maintenance (PPM) schedule, pump oil should be drained and sterilised before discarding together with decontaminated filters, used gaskets, seals and components which have been changed during maintenance. After the PPM schedule, the freeze-drier should be validated to confirm the correct functioning of the drier and components including specialist items added to ensure safe operation. 

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