sop for cleaning Integrity and Replacement of process of Water System

1.0 OBJECTIVE :

1.1 To lay down a procedure for cleaning, Integrity and Replacement of process of Water System.

2.0. SCOPE :

2.1 This SOP is applicable to all water system installed at Pharma Dekho.

3.0. RESPONSIBILITY :

3.1 HOD of EM dept shall be responsible for procurement new filter having the specification mentioned in this SOP.
3.2 Executive shall be responsible for storage of these filters.
3.3 Operator shall be responsible for cleaning of filters.
3.4 Operator shall be responsible for carrying out integrity test as well as replacement of all the filters.
3.5 Operator shall also be responsible for replacement of all utility filters installed in water system,
3.6 Officer / Operator is responsible to ensure the proper disposal of filters after usage/ replacement.

4.0. ACCOUNTABILITY :

4.1 Department Head.

5.0. PROCEDURE :

5.1 All the process filters being used in EM departments are listed in Annex-I
5.2 HOD shall procure the new filter having the specification mentioned in Annex-I
5.3 On receipt of filter, officer/executive shall ensure its adequate closed storage.
5.4 In case of addition of any new filter (not replacement), if procedure is not needed to change then HOD shall ensure to amend only related annexes viz., Annex-I

CLEANNING OF FILTER:

5.5 Cleaning of SS sintered filters used for Pure Steam utility.
5.5.1 Close the main valve of PSG line.
5.5.2 Take out the filter from the housing.
5.5.3 Keep the filter horizontally in hand and wash the filter by air for one minute through the hole of filter (inside) so that water will come out through pores of filter.
5.5.4 Place the filter in its housing.
5.5.5 Frequency of cleaning is as per Annex-I
5.5.6 Cleaning record is to be filled and maintained by water system operator as per Annex- II (to be prepared month-wise).
5.5.7 Affix the label on each filter having information about filter ID No., utility to be filtered, cleaning frequency, installed/replaced by/date, replacement due date.
5.6 Cleaning of PP filters used for soft water utility:
5.6.1 Close the main valve of Soft Water Utility.
5.6.2 Take out the filter cartridge from the housing.
5.6.3 Clean filter with in reverse flow of PW, run the outer surface of the cartridge with gloved hand or smooth mopping pad if required.
5.6.4 Pass PW through the cleaned filter for five minutes and fix into the line.
5.6.5 Fix the cleaned filter in housing and connect into the line.
5.6.6 Frequency of cleaning is as per Annex-I.
5.6.7 Cleaning record is to be filled and maintained by water system operator in Annex-II (to be prepared month-wise).
5.6.8 Affix the label on each filter having information about filter ID No., utility to be filtered, cleaning frequency, installed/replaced by/date, replacement due date.

Integrity of Filters
5.7 Integrity of PP, Pall filters used for Storage Tank:
5.7.1 Perform the integrity (Pre BPT) as per SOP No.
5.7.2 Perform the integrity (Post BPT) as per SOP No.
5.7.3 Frequency of integrity is as per Annex-I
5.7.4 Integrity record is to be filled and maintained by water system operator in Annex- III.

Replacement Frequency of Filters
5.8 Replacement of PP filters used for air utility:
5.8.1 Frequency of Replacement is as per Annex-I
5.8.2 Replacement record is to be filled and maintain by water system operator as per Annex- III (to be prepared month-wise).

5.9 Replacement of PP filters used for Soft Water :
5.9.1 Frequency of Replacement is as per Annex-I
5.9.2 Replacement record is to be filled and maintain by water system operator as per Annex- III (to be prepared month-wise).
5.10 Replacement of SS sintered filters used for Pure Steam utility.
5.11.1 Frequency of Replacement is as per Annex-I.

5.12 Disposal of Filters:
5.12.1 All the replaced filters (used/integrity failed) are to be packed in polythene bag with label as
‘Rejected’ and hand over to personnel department along with inter-office memo for scrap purpose.

6.0 ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.	SOP	Standard Operating Procedure
2.	HOD	Head of Department
3.	PP	Poly Propylene
4.	SS	Stainless Steel
5.	PTFE	Polytetrafluoro Ethylene
6.	IPA	Isopropyl Alcohol
7.	L.	Liter

7.0 ATTACHMENTS (ANNEXES):

Annex-I : List of Filters in water system
Annex-II : Utility filters Cleaning Schedule & Record for water system area for year.
Annex- III : Cleaning, integrity, Sterilization and Replacement of Filter.

8.0. REFERENCE:

In House

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area