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 |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
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sop for Cleaning of Bins and Containers
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sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area