sop for Cleaning procedure of equipment

sop for Cleaning procedure of equipment

 
1.0 OBJECTIVE
1.1 To describe the cleaning procedure of equipment.
2.0 SCOPE
2.1 This procedure is applicable for equipment cleaning 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 Manager Production
5.0 PROCEDURE

5.1 Cleani


ng: Type A procedure ( Batch To Batch Cleaning)
5.1.1 Ensure all the material is removed from the equipment.
5.1.2 Remove the equipment status label as per and affix ‘To be cleaned’ status label as per over the equipment.
5.1.3 Switch off the equipment, Switch off the main power supply.
5.1.4 Isolate the electrical supply.
5.1.5 Type A cleaning applicable for batch to batch cleaning of same strength, color, and flavor and continuous five batches.
5.1.6 Type A cleaning applicable for shift end cleaning.
5.1.7 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.1.8 Remove all left over of previous materials with help of nylon brush, lint free cloth bottom of the equipment.
5.1.9 Clean the Outer surface/ Inner surface area by dry moping of the equipment using lint free cloth.
5.1.10 Remove the sticky material with the help of nylon scrubber.
5.1.11 Switch on the main power supply & Switch on the equipment.
5.2 Cleaning: Type B procedure ( Product To Product Cleaning)
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 sop over the equipment.
5.2.3 Switch off the equipment, Switch off the main power supply.
5.2.4 Isolate the electrical supply.
5.2.5 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.2.6 Prepare required quantity of 0.5% w/v of SLS solution for cleaning.
5.2.7 After continue five batches, Type B cleaning should be perform. And for compression machine after continue three batches; type B cleaning should be performed.
5.2.8 Dismantle all the critical removable parts as per respective sop.
5.2.9 Cover all the dismantled parts using poly bag/stretch wrap and affix ‘To be cleaned’ status label as per sop
5.2.10 Take movable parts of the equipment & shift them to washing area, by using SS trolley.
5.2.11 Dip all small size dismantles parts in potable water in SS container for 10 minutes.
5.2.12 Clean the dismantle parts by moping using lint free cloth with SLS solution, scrub using scrubbing.
5.2.13 Using nylon brush/scrapper, SLS solution dipped lint free cloth removes the product traces from the outer surface and bottom of the equipment.
5.2.14 Spray potable water on the outer surface of the equipment to remove adhere material using nylon scrapper.
5.2.15 Rinse the equipment surfaces using portable water & Ensure the cleanliness of the equipment.
5.2.16 Finally rinse the equipment surfaces & dismantled parts using required quantity of purified water.
5.2.17 Inform IPQA to collect the rinse/swab sample.
5.2.18 Allow them to dry & cover all the dismantled parts using poly bag/stretch wrap and affix ‘Cleaned’ status label as per sop
5.2.19 Transfer all the cleaned dismantled parts to cleaned equipment area.
5.2.20 Check and ensure that all dismantle parts are properly assembled as per respective BPR.
5.2.21 Type B Cleaning Valid For 72 Hours.
5.2.22 Type B cleaning should be performing after maintenance of any contact parts.
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 NIL
9.0 ABBREVIATIONS
9.1 IPQA : In-process Quality assurances
9.2 BMR : Batch manufacturing record.
9.3 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