1.0 Purpose
1.1 To describe a cleaning procedure for proper cleaning of Filter Bag to prevent contamination from one product to another in compliance with quality.
2.0 Scope
2.1 This Sop is applicable for cleaning the
finger bag of Fluid bed Dryer 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 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 Poly bag
5.2 HDPE Drum
5.3 Portable / Tap water
5.4 Purified Water
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 during sweeping of chemicals / powder.
7.0 Procedure
7.1 Shake the finger Bag properly before removing from Hanger after completion of process.
7.2 Collect the finger Bag in a poly bag / container with “To Be Cleaned” label and send to washing area.
7.3 Take the potable water in HDPE / SS drum and dip the finger bag properly.
7.4 Flush the Bag 2 to 3 times by reversing the sleeves.
7.5 Drain the water from the drum and again filled with fresh potable water and add the cleaning agent / Detergent solution.
7.6 Flush the bag with fresh potable water till the entire residue washed off.
7.7 Finally rinse with purified water till the entire residue washed off.
7.8 Hang the bag in washing area at least 30 minutes for removal of water.
7.9 Take the finger bag in a poly bag / container and send to the respective area for drying.
7.10 Dry the bag in FBD and collect it in poly bag then tide it properly.
7.11 Machine operator / worker will request Production Officer and QA Officer for checking visual
inspection.
7.12 At first Production Officer will check the filter bag, then QA Officer will check the filter bag. If it found satisfactory result, then he / she will issue “Cleaned” label and to fix the label.
7.13 Store the bag in clean poly bay with proper labeling and filled.
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.