1.0 Purpose
1.1 To define the procedure to describe the cleaning of accessories for liquid products manufacturing line.
2.0 Scope
2.1 This procedure is applicable to the cleaning accessories for liquid products manufacturing line 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 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.
4.2 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. or
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 / Scrubber
5.1.3 Potable Water
5.1.4 Purified Water
5.1.5 Detergent Solution, 0.4% (w/v) Sodium
lauryl Sulphate
5.1.6 Disinfectant solution : Savlon
Solution (5% v/v) or Dettol Solution (2.5% v/v)
5.1.7 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 Transfer pipes and filling pipes:
7.1.1. Set the supply line of potable water at one end of the pipe and
let the water passes through the
Pipe to remove dust.
7.1.2. Set the one end of the pipe with transfer pump and SS vessel contains hot purified water (75⁰ C) and circulates the hot purified water through the pipe to remove dust. “or”
Sink the pipes for 15 minutes in SS vessel containing hot purified water and let the dust inside the pipe be soaked properly with hot purified water.
7.1.3. Hold both ends of the pipe with two hands and shake well to remove dust. Repeat the procedure for 4 times.
7.1.4. Finally wash outside and inside of the pipe with purified water.
7.1.5. Wipe adhered water of the outer side of the pipe with clean dry Lint
Free Cloth, hang the pipe upside down until complete removal of inside water and
allow them to dry.
7.2 Plastic Container (Beaker, Measuring Cylinder etc.):
7.2.1 Remove dust with clean, dry cloth.
7.2.2 Wash with potable water.
7.2.3 Finally wash with purified water.
7.2.4 Wipe adhered water with clean dry cloth
and allows them to dry.
7.2.5 After
completion of cleaning, fix “CLEANED”
label.
7.3 SS Container (Bucket, mug etc.):
7.3.1 Remove dust with clean, dry cloth.
7.3.2 Wash with potable water.
7.3.3 Wash with hot purified water.
7.3.4 Wash with purified water.
7.3.5 Wipe adhered water with clean, dry cloth.
7.3.6 Finally wipe with 70% Isopropyl alcohol-soaked
cloth and allow them to dry.
7.3.7 After
completion of cleaning, fix “CLEANED”
label.
7.4 SS
utensils:
7.4.1 Take all the utensils in a SS container /
plastic drum / polythene bag and fix “TO
BE CLEAN” label.
7.4.2 Remove dust with a clean, dry cloth.
7.4.3 Wash with potable water.
7.4.4 Wash with hot purified water.
7.4.5 Wash with purified water.
7.4.6 Wipe adhered water with clean, dry cloth.
7.4.7 Finally wipe with 70 % Isopropyl alcohol-soaked
cloth and allow them to dry.
7.4.8 Take all the
cleaned utensils in a polythene bag. Fix “CLEANED”
label in place of “TO BE CLEAN” label
at the polythene bag that contains clean equipment.
7.5 For Room / Area:
7.5.1 Clean all machineries of Liquid Manufacturing area according to cleaning procedures of the specified machine.
7.5.2 Clean the wall and ceiling by proper mop / wet cloth.
7.5.3 Sweep floor with plastic broom / dry mop and collect waste and store it into waste bin.
7.5.4 Clean the floor with water hose.
7.5.5 Scrub the floor with rubber scrubber and discharge scrub water into discharge hole.
7.5.6 Wipe the wall and ceiling with dry cotton cloth.
7.5.7 Wipe the floor with cotton mop.
7.5.8 Mop with Savlon Solution (5% v/v) or Dettol Solution (2.5% v/v) on rotate weekly or as per cleaning schedule.
7.5.9 Allow the room for natural drying.
7.5.10 Waste bin
7.5.10.1 Remove waste and transfer to dedicated area for proper waste management.
7.5.10.2 Rinse the waste bin with potable water to remove dust completely.
7.5.10.3 Let it be dry.
7.6 Electric board, switch control panel should be cleaned with dry lint free cloth.
7.7 After completion of cleaning remove “TO BE CLEAN” label and fix “CLEANED” label on the equipment and record the cleaning
action in equipment and room cleaning logbook.
8.0 Reference Document
8.1 In-House;
9.0 Annexure
9.1 None
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.
