Validation sterilisation procedure

Packaging and validated sterilisation procedures to ensure sterility... 

The method of manufacture must ensure reproducibility between batches and the conditions should be chosen to preclude the possibility of contamination with other plastic materials or their constituents. Containers made should be similar in every respect to the type sample. For the testing on the type sample to remain valid, there must be no change in the composition of the material or in the manufacturing process, particularly with regard to temperature to which the plastic material is exposed during conversion or subsequent procedures such as sterilisation. Scrap materials should not be used. Recycling excess material of a well-defined nature and proportion may be permitted if the appropriate validation is carried out. 

Each procedure used for the sterilisation of a particular quantity or volume of a material, component, or product should have been demonstrated to be effective and reliable by suitable validation studies (see Validation). 

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. 

Validating the efficiency of a gaseous biocide is often imprecise because it is difficult to measure the parameters associated with the decontamination procedure with precision (compare this with steam sterilisation below) and validation exercises consequently rely heavily on the use of biological indicators. 

All mentioned sterilisation methods allow for different conditions, as long as the procedures and precautions are chosen as such that a SAL of 10 is obtained [1]. However broad sterilisation experience, good knowledge of GMP and process validation are necessary to work with different conditions. In many pharmacies and industries the standard methods are used in practice. 

Qualification and validation can be outsourced. However, the responsibility remains in-house so the craitract-taker has to be approved according to current GMP requirements for outsourced activities [10]. For example, the following qualification and validation items can be outsourced LAF cabinets, safety cabinets, HVAC-systems, sterilisers, rinsing machines and devices for performing filter integrity testing. When tasks of qualification and validation are outsourced, internal approval of protocols, raw data and reports have to take place according to internal procedures. 

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