To lay down a procedure of cleaning dispensing area.
This procedure is applicable for cleaning of dispensing area of pharmaceutical formulation Plant.
Officer/above- Warehouse is responsible for implementation of this SOP.
Head – Warehouse shall be accountable for implementation and compliance of this SOP.
5.0 Abbreviations and Definitions :
- SOP : Standard Operating Procedure
- WH : Warehouse
- SS : Stainless Steel
- v/v : Volume by Volume
- IPA : Isopropyl Alcohol
- HEPA: High Efficiency particular Air
- No: Number
- Ref: Reference
- No: Serial Number
6.1 Procedure for cleaning of dispensing area:
6.1.1 Check the electric supply of RLAF (reverse laminar air flow) is switched-off.
6.1.2 Clean the ground surface of dispensing area & the corners with vacuum cleaner. Vacuum cleaner to be cleaned as per respective SOP before taken in use.
6.1.3 Precaution: Electric panel shall be cleaned with dry lint free cloth, switch off all balances before cleaning.
6.1.4 Wipe from top to bottom S. S. grills, metal surfaces, shields and balances with a cleaned lint free cloth wetted with IPA (70% v/v).
6.1.5 Wipe the above mentioned part with dry lint free cloth and inspect the same for any stains or unclean area.
6.1.6 Mop the entire ground surface area with a cleaned floor duster wetted with a disinfectant solution weekly on rotational basis with Domex 2.5%, Lyzol 2.5% & Savlon 2.5% with contact period of 10-15 minutes. Finally wipe the floor by dry floor duster.
6.2 Record the observation in Annexure-III.
6.3 Affix the ‘CLEANED’ label Ref: Annexure No.-I.
6.3 Procedure for cleaning of dispensing booth:
6.3.1 After completion of previous product dispensing affix status label “To Be Cleaned” Annexure No.-II.
6.3.2 Check and record the differential pressure across pre-filter, fine filter and HEPA filter before the start of cleaning in Annexure-IV.
6.3.3 Remove the powder deposition from the pre-filter grills, walls, top, corners, and riser filter grills of the dispensing booth by using vacuum cleaner.
6.3.4 Clean the pre-filters and fine filters grills, walls corners return air riser grills, of the dispensing booth with moist lint free duster dipper in purified water followed by a lint free duster.
6.3.5 Clean the pre-filters and fine filters in the end of shift, cleaning done by engineering personnel Ref: Annexure No.-III.
6.3.6 Check and record the differential pressure across the pre filter, Fine filter and HEPA filter in format no. WHSG008/F04 after the completion of cleaning activity of the dispensing booth
6.3.7 Record the observation in Annexure-III.
6.3.8 Affix the ‘CLEANED’ label Ref: Annexure No.-I.
6.3.9 Before dispensing of another product, all the dispensing aid should be in a different poly bag with ‘clean’ labeled with duly filled and signed.
7.0 List of Annexure / Formats
Cleaned Label : Annexure-I
To be Cleaned Label : Annexure-II
Cleaning Record for Dispensing Area : Annexure-III
Filters and return air Riser cleaning log : Annexure-IV
SOP on SOPs.
9.1 Master Copy : Documentation Cell (Quality Assurance)
9.2 Controlled Copies : Quality Assurance, Warehouse.
|Date||Revision Number||Reason for Revision|
EQUIPMENT NAME /ID No. :
PREVIOUS PRODUCT :
CLEANED TIME :
CLEANED BY : CHECKED BY:
SIGN/DATE SIGN /DATE
To be Cleaned Label
TO BE CLEANED
EQUIPMENT NAME /IDNo. :
PRODUCT NAME :
BATCH NO. :
CLEANING RECORD FOR DISPENSING AREA
LOCATION: ID No.:
|Sr. No.||Date||Area||Cleaning/ Sanitization||status||Cleaned
Filters and return air Riser cleaning log