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Cleaning of general item

Cleaning of general item

OBJECTIVETo lay down a procedure to describe the steps to be followed for cleaning general items.

SCOPE: Applicable for cleaning all HDPE / SS containers, utensils, scoops, sampling tools and different cleaning aids

RESPONSIBILITY: Housekeeping workers, Production Supervisors, Operators, IPQA personnel shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITY: Production Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.

ATTACHMENTSNot applicable

PROCEDURE:

Cleaning of sampling tools

Sampling Thieves

Spoons

Scoops

After every single use transfer the above mentioned items to washing area for cleaning.

Clean the items with process water along with scrubbing with the help of a clean nylon brush. Continue this operation till all the adhered materials are removed.

Connect hose to the purified water outlet. Open the valve and allow purified water to drain for 1 minute.

Finally flush the sampling tools with the purified water. Ensure proper cleaning.

Place the items in a clean SS container and transfer under ‘Cleaned’ Infra-red dryer.

Operate the Infra-Red Dryer as per the SOP to dry the items.

Collect the dried items. Affix ‘Cleaned’ status label mentioning all the details and store in ‘Clean vessel room’

Cleaning of HDPE / SS Drums, Utensils and Buckets (after every single use).

After every single use affix ‘To be cleaned’ label and transfer the above mentioned containers to washing area for cleaning.

Wash the above items with process water.

Scrub the inner and outer walls of the containers with a clean nylon brush. Continue this operation till all the adhered material is removed.

Finally rinse the items using purified water.

Transfer the containers under the ‘Cleaned’ Infra-Red Dryer and operate the Infra-Red Dryer as per SOP to dry the containers.

After the completion of drying transfer the clean dried containers in ‘Clean Vessel Room’, store them on pallets/racks and affix ‘Cleaned’ status label with all details.

Note: Apply the stretch films around the mouth of the containers.

Cleaning of cleaning Aids (after every single use).

Nylon Brush

Scrubber

Scrappers

After every single use transfer the above mentioned cleaning aids to washing area for cleaning.

Dip the cleaning aids in a container holding process water for 30 minutes.

Scrub them with the help of a clean nylon brush. Continue this operation till all the adhered material is removed.

Finally rinse the cleaning aids with purified water. Ensure proper cleaning.

Transfer the cleaned items in a SS container under ‘Cleaned’ Infra-Red Dryer.

Operate the Infra-Red Dryer as per SOP to dry the items.

Collect the dried items. Affix ‘Cleaned’ status label mentioning all the details and stored in ‘clean vessel room’.

REFERENCES :

In-house

ABBREVIATIONS :

SOP    : Standard Operating Procedure

QA      : Quality Assurance Department

HDPE : High Density Polyethylene

SS       : Stainless Steel

DISTRIBUTION LIST:

QA Department

Production Department

Quality Control Department

HISTORY OF REVISION:

Version Number Effective Date Reason for Revision
00 New SOP

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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

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