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Abstract

The subject of this work is the validation of sterile filtration. This work describes how to do a risk analyse, a validation and show the results of a validation. It includes background information about the sterile filtration, sterile filters and the demands on the mediums. For the sterile filtration used filters are the Pall Junior SBF1 NFZ PH4, the Pall Sealklean SLK 7002 NFP, the Sartolab P 20 plus, the Sartobran P, the Millipak-20 Gamma Gold, the Pall arcodisc syringe filter and the Pall AB 1EBV7PH4. Sterile filtration is used for liquids which cannot be thermically sterilised. The study shows the sterile filtration systems and devices which are used at the manufacturing of vaccines. The practical work for validation of these processes is shown. The sterile filtration is used if the steam sterilisation in an autoclave is not possible. The cause can be amino acids and proteins. The results of this validation are written down in this paper. Every time it is produced a sterile product by use of the sterile filtration. The endotoxine in the product complies with the requirements every time. So the validation of the sterile filtration was completed successful now for the Pall Junior SBF1 NFZ PH4, the Pall Sealklean SLK 7002 NFP, the Sartolab P 20 plus, the Sartobran P, the Millipak-20 Gamma Gold and the Pall arcodisc syringe filter. The validation for the AB 1EBV couldn´t finished yet, because it was no integrity measurement possible. The missing test parameters become produced by the filter producer now.