SOP on Control and Cleaning of S.S. items used in Production

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

For More Pharma Updates Visit –https://pharmaguidances.com

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

PROCESS VALIDATION PROTOCOL OF TACROLIMUS CAPSULES

PROCESS VALIDATION PROTOCOL  TACROLIMUS CAPSULES Tacrolimus is administered in conjunction with other medications to inhibit …