1.0 Purpose
1.1 To describe a cleaning procedure for proper cleaning of Mesh to prevent contamination from one product to another in compliance with quality.
2.0
Scope
2.1 This Sop is applicable for cleaning of
different size of Mesh of tablet manufacturing area at "NAME" Pharmaceuticals
Ltd.
3.0
Responsibility
3.1
Only concern operator is
responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation.
3.2
Sr. Officer-
Production/Officer- Production is responsible for monitoring day to day
activity.
3.3
Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 Definition of Mesh: The number of openings per linear inch of a screen.
4.2 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 Portable / Tap water
5.2 Purified Water
5.3 Hand brush
5.4 Clean lint free cloth
5.5 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..
6.0 Precaution / Health and Safety Considerations
6.1 Use mask, Hand gloves during operation.
7.0 Procedure
7.1 Remove residual powder from the respective mesh by clean cloth / vacuum cleaner after operation.
7.2 Wet rest of the powder adhered with the mesh with a lint free cloth soaked in portable water.
7.3 Keep the mesh in a poly bag and take it in washing room.
7.4 Pass compressed air through mesh to remove blockade of granules and powder.
7.5 Wash the mesh with potable water thoroughly.
7.6 Rub the surface of the mesh with nylon brush soaked in 0.4 % Sodium Lauryl Sulphate solution.
7.7 Wash the mesh with potable water that no residue of Sodium Lauryl Sulphate solution remains.
7.8 Finally rinse with purified water.
7.9 Wipe the surface of the mesh with dry clean lint free duster to remove the water and then 70% IPA (Isopropyl Alcohol) solution to remove surface water.
7.10 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.11 At first Production Officer will check the mesh, then QA Officer will check the mesh. If it found satisfactory result, then he / she will issue “Cleaned” label and to fix the label.
7.12 Keep the mesh in a poly bag and take this in clean equipment room with a “CLEANED” Tag mentioning Previous Product Name, Batch Number, and Cleaned by and checked by.
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 production operator and worker.
