REDUCTION IN THE USE OF CARTRIDGE FILTERS

SITUATION:Sartobran P cartridge filters are being used for the filtration of Skilax Drops bulk solution. New filter is used every time for the new batch. Cartridge filter assembly is sterilized after every use but without cartridge filter and cartridge is fitted after sterilization which is principally wrong. No. of Batches / Month=27No. of Batches / Year=324Price / Filter=12000 PKRAnnual Expense=3,888,000 PKR

PROPOSAL:Re-Use of Filters after AutoclavingThermal stability data of Sartobran P cartridge filters shows that these filters can be autoclaved Min. 25 times at 134oC/2 Bar for 30 mins. Technical Reference: Validation Guide SPK 5726-e BENEFIT:Reduction in the usage of Sartobran P filters. Single Filter can be used 25 times i.e. for 25 batches.No. of Batches / Year=324No. of Filters Required=13Approx. Annual Expense=156,000 PKRApprox. Annual Saving=3,732,000 PKR

PROPOSED PROCEDURE:After filtration of each batch, cartridge filter fitted in cartridge assembly will be flushed with purified water. After flushing, filter fitted in assembly will be sent for autoclaving at 134oC at 2 Bar pressure for 30 mins. After Autoclaving, filter along with housing will be put inside a polythene bag till further usage. Hold Time Study will be performed for sterilized filter with housing. (for a period of 72 hours) Bubble Point Test (Integrity Test) of filter will be performed before and after use, initially on daily basis and upon satisfactory data on weekly basis.

PROCESS VALIDATION: Sterility test will be performed on autoclaved filters for three consecutive runs to validate the autoclaving process. Bio-validation (if possible) will be performed to ensure the autoclaving process. Hold Time Study for sterilized filters will be performed to determine the Best Before time for sterilized filters.