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

27

No. of Batches / Year

324

Price / Filter

12000 PKR

Annual Expense

3,888,000 PKR

PROPOSAL:
Re-Use of Filters after Autoclaving
Thermal 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

324

No. of Filters Required

13

Approx. Annual Expense

156,000 PKR

Approx. 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.