1.0 Purpose
1.1 To describe a cleaning procedure for proper cleaning of Manufacturing Room to prevent contamination from one product to another in compliance with quality.
2.0 Scope
2.1 This Sop is applicable for Manufacturing Room of “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1
Cleaners and Operators are
responsible for normal operation. He/ She inform the supervisor about any
deviation from normal operation. He also maintains logbook.
3.2
Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 Contamination: Contamination is the presence of any foreign substance in our products. It may be: Physical : hair, foreign objects, dirt, dust, pollens.
Chemical : cleaning agents, lubricants, other products.
Microbiological : bacteria, molds, spores, yeasts.
5.0 Materials and Equipment
5.1 Dry Mop
5.2 Waste Bin
5.3 Round mop with bucket
5.4 Clean lint free cloth
5.5 Vacuum cleaner
5.6 Detergent Solution: 0.4% (w/v) Sodium Lauryl Sulphate solution ; 4 gm Sodium lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare detergent solution.
5.7 Disinfectant Solution: Solution used to make free from microorganism.
5.8 Savlon Solution (5% v/v):50 ml is mixed with 1.0 liter of tap / portable water to prepare disinfectant solution. or
5.9 Dettol Solution (2.5% v/v): 25 ml is mixed with 1.0 liter of tap / portable water to prepare disinfectant solution.
6.0 Precaution / Health and Safety Considerations
6.1 Use respiratory mask during sweeping of chemicals / powder.
7.0 Procedure
7.1 Cleaning for Change Over of Different Product (Product to Product Change Over)
7.1.1 Clean all machineries of manufacturing area according to cleaning procedures of the specified machine.
7.1.2 Remove the dust from wall and ceiling by using the dry cloth /duster.
7.1.3 Clean the wall and ceiling by proper mop / wet cloth to eliminate powder.
7.1.4 Sweep floor with dry mop and collect waste powder and store it into waste bin.
7.1.5 Take the detergent solution in bucket of round mop and mop the floor with rubber mop and clean the floor.
7.1.6 Take disinfecting solution in bucket of round mop and wipe the floor with round mop.
7.1.7 Allow the room for natural drying.
7.2 Cleaning for Change Over of Same Product (Batch to Batch Change Over)
7.2.1 Clean all machineries of manufacturing area by Clean dry cloth / vacuum cleaner.
7.2.2 Sweep floor with dry mop and collect waste powder and store it into waste bin.
7.3 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.4 At first Production Officer will check the area and its surroundings, then QA Officer will check the area and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label and give initial in respective room log.
8.0 Reference Document
8.1 In-house
9.0
Annexure
9.1 Not Appreciable
10.0
Revision
History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0
Training
11.1 Head of Production or his nominee give
the training of cleaner, production operator and worker.
