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sop for Handling of Filters

 

sop for Handling of Filters

 

1.0 OBJECTIVE:
To lay down a Procedure for the Handling of Filters.

2.0 SCOPE:
This SOP is applicable for the Handling of Filters of Production area

3.0 RESPONSIBILITY:
Officer / Executive – Production

4.0 ACCOUNTABILITY:
Head – Production

 

5.0 PROCEDURE:
5.1 After filtration take integrity if it is pass, then transfer to the washing and sterilization area and pass WFI for 15 Minutes.
5.2 If the same filter is to be used in continuation then again transfer the product filter to the filtration Area.
5.3 If the filter is not to be used in continuation proceed for clean the filter with WFI with for 15 minutes.
5.4 After cleaning of filter pass the steam for 5 minutes, followed by 0.2µ filtered compressed air

and Wrap with parchment paper properly & affix the status label.
5.5 Store the properly cleaned & labeled cartridge filter in cupboard provided in “clean equipment Storage room” of washing and sterilization area.
5.6 Whenever to be reuse of above filter pass the Water For Injection for 5 minutes at room temperature and then installed to the filter housing.
5.7 Record the sterilization cycle in (Annexure-II) Filter Integrity and Sterilization Record log book.



6.0 ABBREVIATIONS:

SOP                      :   Standard Operation Procedure
WFI                      :   Water for Injection
No.                        :   Number
Pvt                          :Private limited
QA                         : Quality assurance

7.0 ANNEXURES:

Annexure No. Title of Annexure Format No.
Annexure-I                      : Filter record label
Annexure-II                    :Filter Integrity and Sterilization record

8.0 DISTRIBUTION:
a) Master Copy                   :  Quality Assurance
b) Controlled Copy             : Production department

9.0 REFERENCES:

In House

ANNEXURE – I
FILTER RECORD LABEL
Filter catalogue Number
Filter Serial Number
Date of installation
Integrity Done On
Integrity Due On
Done By & Date
Checked By & Date

 

ANNEXURE-II

FILTER INTEGRITY AND STERILIZATION RECORD

Date Integrity Done On No. of Sterilization Cycle Batch No. Done By (Sign & Date) Checked By (QA) Sign & Date

Destruction Detail

Remark
Done By (Prod.)

Sign & Date

Checked By (Prod.)

Sign & Date

Verified By (QA)

Sign & Date

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