SOP on Control and Cleaning of S.S. items used in Production
Objective: To lay down a procedure for Control and Cleaning of S.S. items used in Production.
Scope: This standard operating procedure is applicable for Control and Cleaning of S.S. items used in Production, at formulation plant of pharmaceutical company name with location.
Responsibility
Trained Worker / Operator shall be responsible for control and cleaning of S.S. items.
Production Supervisor / Officer shall be responsible for implementation of this SOP.
Head-Production / designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
S.S.- Stainless Steel
IPC – In-Process containers
SOP- Standard operating procedure
QA – Quality Assurance
Procedure
S.S items
Identification number of small S.S. items shall be according to the area in which they are used. For numbering of S.S. items, the S.S. items are divided set wise with respect to the area in which they are used.
The cleaning of S.S. items shall be done by scrubbing with nylon brush using sufficient quantity of potable water. Use 0.5 % w/w Sodium Lauryl Sulphate solution in potable water as a cleansing agent if required.
Wash the S.S. items with sufficient quantity of potable water till complete removal of cleansing agent.
Finally rinse the S.S. items with sufficient quantity of Purified Water.
Collect washed small S.S. items in a S.S. trolley and request IPQA to collect wash water sample.
Wipe each S.S. item with clean dry non-shredded cloth.
Affix a ‘UNDER CleanING’ label duly filled and signed on the S.S. trolley.
After receiving wash water analysis report for compliance remove the previous status label and affix ‘CLEANED’ status label duly filled and signed on the machine
Frequency:-The cleaning shall be done according to the respective area cleaning.
NOTE: – S.S. Containers having capacity more than 30 kg / Liter shall not be include in S.S. Items set.
Forms and Records
Not Applicable
Distribution
Master Copy -Documentation Cell (QA)
Controlled Copies -Production, Quality Assurance and Quality Control
8.0 History
Date |
Revision Number | Reason for revision |
| – | 00 | New SOP |
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