1.0 Purpose
1.1 To describe the cleaning and changeover procedure of Liquid Manufacturing Vessels.
2.0 Scope
2.1 This procedure is applicable to the cleaning and changeover of Liquid Manufacturing Vessels of “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only trained operator is responsible for normal operation. He/ She inform the supervisor about any deviation from
normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.
4.0 Abbreviations and Definitions
4.1 Type-A Cleaning: This type of cleaning is defined as cleaning procedure followed during product-to-product change
over. If the unit or equipment is used for same product, it has to be cleaned after 72 hours.
4.2 Type-B Cleaning: This type of cleaning is defined as cleaning procedure for batch to batch of same product.
4.3 Detergent Solution, 0.4% (w/v) Sodium Lauryl Sulphate: 4 gm Sodium lauryl Sulphate is dissolved in 1.0 liter of
portable / tap water to prepare detergent solution.
4.4 Disinfectant Solution: Solution used to make free from microorganism.
Savlon Solution (5% v/v) :50 ml is mixed with 1.0 liter of tap / portable water to prepare disinfectant solution.
Dettol Solution (2.5% v/v): 25 ml is
mixed with 1.0 liter of tap / portable water to prepare disinfectant solution.
5.0 Materials and Equipment
5.1 Ensure following Cleaning Equipment/ Tools/ Agent are used in order to clean.
5.1.1 Lint Free Cloth
5.1.2 Wiper / nylon scrubber
5.1.3 Potable Water
5.1.4 Purified Water
5.1.5 SS Ladder
5.1.6 Gumboots
5.1.7 Detergent Solution, 0.4% (w/v) Sodium lauryl Sulphate
5.1.8 Disinfectant solution: Savlon Solution (5% v/v) or Dettol Solution (2.5% v/v)
5.1.9 Isopropyl Alcohol Solution (70%)
6.0 Precaution / Health and Safety Considerations
6.1 Ensure that the Operator wears Uniform, face mask.
7.0 Procedure
7.1 Product to Product Cleaning (Type-A Cleaning)
7.1.1 Initially removes all the residual material from the vessel.
7.1.2 Scrub the inner surface and wash with Detergent Solution, [0.4% (w/v) Sodium Lauryl Sulphate] and potable
water.
7.1.3 Wash with hot purified water. (by transfer pump.)
7.1.4 Rinse with purified water.
7.1.5 Wipe adhered water with clean, dry lint free cloth.
7.1.6 Finally wipe with 70% Isopropyl alcohol-soaked cloth and allow them to dry.
7.2 Batch to Batch Cleaning (Type-B Cleaning)
7.2.1 Initially removes all the residual material from the vessel.
7.2.2 Wash with hot purified water.
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 vessels and its surroundings, and then QA Officer will check the
vessels and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.
7.5 Record in liquid manufacturing vessels logbook and attach the label of “Cleaned” in vessel.
7.6 After cleaning the liquid manufacturing vessels
if it remains without operation for next 72 hour, will undergo Re-cleaning operation.
.
8.0 Reference Document
8.1 In-House
9.0 Annexure
9.1 Annexure- I : Format of Machine Logbook
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.
