SOP for Cleaning of process Filters

This Document describes (Standard Operating procedure) SOP for Cleaning of process Filters used for vial washing machine.

SOP for Cleaning of process Filters

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for Cleaning of process Filters used for vial washing machine.
• This procedure is applicable to production Department personnel for Cleaning of process Filters used for vial washing machine.

II. Responsibilities:

• All production personnel shall be responsible to follow and implement this SOP.

III . Introduction and Procedural Part :

Procedure for Cleaning of process Filters :

• Remove filters from its filter housing by opening the tri clover joint of each and transfer all the filters from following location to unit preparation room.
• Vial washing machine for Recycled water, purified water, Water for Injection (WFI), compressed air. Qty.: 04 Nos.

Filter ratings:

• Collect 10 liters of Water for Injection (WFI) in cleaned Stainless Steel (S.S.) container.
• Clean each filter by immersing in WFI with intermittent shaking.
• Keep all the washed filters on the machine parts washing table.
• Drain out the waste water of washed filters in drain.
• Clean the S.S. container with WFI.
• Collect approx. 10 liters of WFI.
• Rinse each filter by immersing in WFI with intermittent shaking.
• Check physically all the filters. Place all the filters to their respective locations in filter housing.
• At the end of the shift, open all the tubing’s connection to drain water. Ensure water is drained from tubing’s and recycled water tank.
• Clean the machine with lint free cloth.
• Ensure that all pipeline and tanks are dried before shutdown activity.

Frequency:

Weekly or as an when required.

Note: If there is no activity/ shutdown, then filter cleaning shall be done before start of the activity.