sop for cleaning issuance and retrieval of accessories and change parts

sop for cleaning issuance and retrieval of accessories and change parts

1.0 OBJECTIVE
1.1 To describe the cleaning, issuance and retrieval of accessories and change parts.
2.0 SCOPE
2.1 This procedure is applicable for accessories and change parts present in the production department.
3.0 RESPONSIBILITY
3.1 Operator – To perform the procedure.
3.2 Executive production- To ensure that the operation is being performed in compliance with the
SOP.




3.3 IPQA person – To ensure in-process checks, and counter check that the
Compliance is in line with SOP.

4.0 ACCOUNTABILITY
4.1 Department Head




5.0 PROCEDURE
5.1 Cleaning: Type A procedure (Batch To Batch Cleaning)
5.1.1 Ensure all the material is removed from the equipment.
5.1.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.1.3 Type A cleaning applicable for batch to batch cleaning of same strength, color, and flavor and continuous seven batches.
5.1.4 Type A cleaning applicable for shift end cleaning.
5.1.5 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.1.6 Remove all left over of previous materials with help of nylon brush, lint free cloth bottom of the equipment.
5.1.7 Clean the Outer surface/ Inner surface area by dry moping of the equipment using lint free cloth.
5.1.8 Remove the sticky material with the help of nylon scrubber.
5.1.9 Note: Accessory means S.S. Spatulas, S.S. Scoops, S.S Containers, tanks, S.S. Trays, liquid transfer pump with SS pipe line with clamp, hose pipe, PVC pipe all the change part of machine, strip machine, & all other utensil.
5.2 Cleaning: Type B procedure
5.2.1 Ensure all the material is removed from the equipment.
5.2.2 Remove the product status label and affix ‘To be cleaned’ status label as per over the equipment.
5.2.3 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.2.4 Prepare required quantity of 0.5% w/v of SLS solution for cleaning.
5.2.5 After continue five batches, Type B cleaning should be performed.
5.2.6 Take accessories and change parts of the equipment & shift them to washing area, by using S.S trolley.
5.2.7 Dip all small size accessories and change parts in potable water in S.S container for 10 minutes.
5.2.8 Clean the accessories and change parts by moping using lint free cloth with SLS solution, scrub using scrubbing.




5.2.9 Using nylon brush/scrapper, SLS solution dipped lint free cloth removes the product traces from the outer surface and bottom of the accessories and change parts.
5.2.10 Spray potable water on the outer surface of the accessories and change parts to remove adhere material using nylon scrapper.
5.2.11 Rinse the equipment surfaces using portable water & Ensure the cleanliness of the accessories and change parts.
5.2.12 Finally rinse the accessories and change parts surfaces & dismantled parts using required quantity of purified water.
5.2.13 Inform IPQA to collect the rinse/swab sample as per sop.
5.2.14 Allow them to dry & cover all the dismantled parts using poly bag/stretch wrap and affix ‘Cleaned’ status label as per sop
5.2.15 Transfer all the cleaned accessories and change parts to cleaned equipment area.
5.2.16 Check and ensure that all accessories and change parts are properly assembled as per respective BMR/BPR.
5.2.17 Type B Cleaning Valid For 72 Hours.
5.2.18 Type B cleaning should be performing after maintenance of any contact parts.
5.3 ISSUANCE AND RETRIEVAL OF CHANGE PARTS
5.3.1 When required of change parts intimate the officer production.
5.3.2 Officer production issue the change parts to operator and maintain the record of
Issuance.
5.3.3 After used of change parts return to Officer production by operator.
5.3.4 Officer production maintains the record of used and retrieval.
5.3.5 Frequency of PVC pipe, gasket, and hose pipe one-year replacement or whenever required.

6.0 TRAINING
6.1 Trainer: Department Head.
6.2 Trainee: Production, Quality Assurance and Operator person.
6.3 Period: one hour or as per required.
7.0 DISTRIBUTION
7.1 One set of Master copy and one set of Controlled copy submit the QA department.
8.0 ENCLOSURES




8.1 Cleaning Log Book.
9.0 ABBREVIATIONS
9.1 IPQA : In-process Quality assurances
9.2 BMR : Batch manufacturing record.
9.3 BPR : Batch Packing record.
9.4 SOP : Standard operating Procedure.
9.5 QC : Quality Control
9.6 w/v : Weight/volume
9.7 % : percentage
9.8 SLS : Sodium laurel sulphate
9.9 SS : Stainless steel
10.0 DOCUMENT CHANGE HISTORY

Revision Reason for revision Effective Date

 

00 NEW SOP      

 

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sop for cleaning issuance and retrieval of accessories and change parts

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sop for Fogging in Aseptic and Non Aseptic Area

 

 

 

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