1.0 Purpose
1.1 To define a standard operating and cleaning procedure of semi automatic rotary washing machine.
2.0 Scope
2.1 This procedure is applicable for semi automatic rotary bottle washing machine in liquid production area 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 Not Appreciable
5.0 Materials and Equipment
5.1 Nylon Scrubber
5.2 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 Don’t press electric switch with wet hand.
6.2 Ensure that the Operator wears Uniform, face mask and hand gloves.
6.3 Ensure that before starting the machine: the bottleneck should not be touching the jet nozzles.
6.4 Check the pump pressure should be around 2 Kg/cm2.
7.0 Procedure
7.1 Preparation for operation
7.1.1 Connect purified water to the purified inlet valve.
7.1.2 Connect air pipe to the air connector.
7.1.3 Check the turn table’s rotating direction.
7.1.4 Adjust the height of the bottles and the distance between the push guide and the bottom of the bottles to about 3-
5 mm. Finally, tighten the nut.
7.1.5 Adjust the speed of the turn table. Turn clockwise to slow down speed & anti clockwise to speed up.
7.1.6 Open water and air source valve.
7.2 Operation of bottle washing machine
7.2.1 Switch “ON” the main power supply.
7.2.2 Press turn table “ON” button.
7.2.3 Use speed adjust switch to control the table rotating speed.
7.2.4 Push the purified water “ON” button.
7.2.4 Start washing operation after checking the machine by production Officer and QA Officer.
7.3 Regular cleaning of bottle washing machine after each operation
7.3.1 After washing operation, write the status label “To Be Cleaned” and fix it of the machine.
7.3.2 Remove residue of previous bottle and broken glass particle inside and around the machine.
7.3.3 Take 100 liter purified water in storage tank-2 and heats purified water up to 75⁰ C; then transfer hot purified water
to storage tank-1.
7.3.4 Circulate the hot purified water at least 10 minutes to rinse the whole machine.
7.3.5 Clean the whole machine and both storage tanks with wet cloth.
7.3.6 Clean the whole machine and both storage tanks with dry lint free cloth.
7.3.7 Finally clean the machine and both storage tanks with 70% IPA.
7.3.8 Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.
7.3.9 At first Production Officer will check the machine and its surroundings, then QA Officer will check the machine and its
surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.
7.3.10 Record in Bottle washing Machine logbook and attach the label of “Cleaned” in the machine.
7.3.11 After cleaning the bottle washing machine if it remains without operation for next 72 hour, will undergo Re-cleaning
operation.
7.3.12 Cleaning has to be performed at every product change over.
7.3.13 Before machine operation, it is mandatory to run machine with hot purified water (75⁰ C) at least 10 minutes.
7.4 Machine Sanitation
7.4.1 Storage tanks cleaning:
7.4.1.1 Clean the both storage tanks properly with purified water.
7.4.1.2 Scrap the both storage tanks with 0.4 % w/v sodium lauryl sulphate solution.
7.4.1.3 Clean the both storage tanks with purified water.
7.4.1.4 Clean the both storage tanks with hot purified water (75⁰c).
7.4.1.5 Clean the both storage tanks with dry lint free cloth.
7.4.1.6 Finally wipe the both storage tanks with (70%) Isopropyl Alcohol.
7.4.2 Machine Cleaning:
7.4.2.1 Remove residue of previous glass from the surrounding area of the machine.
7.4.2.2 Apply compressed air to completely remove the broken glass particle from the machine.
7.4.2.3 Open the SS cover, bottle holder, SS platform and other removable parts
7.4.2.4 Clean the all removable parts with 0.4 % w/v sodium lauryl sulphate solution and then cleaned with purified
water.
7.4.2.5 Clean the outer and inner side of the machine with 0.4 % w/v sodium lauryl sulphate solution and then cleaned
with purified water.
7.4.2.6 Set the full machine properly.
7.4.2.7 Take 100 liter purified water in storage tank-2 and heats purified water up to 75⁰ C; then transfer this hot purified
water to storage tank-1. (2 times)
7.4.2.8 Circulate the hot purified water at least 20 minutes to rinse the whole machine.
7.4.2.9 Clean the whole machine and both storage tanks with wet cloth.
7.4.2.10 Clean the whole machine and both storage tanks with dry lint free cloth.
7.4.2.11 Finally clean the machine and both storage tanks with 70% IPA.
7.4.3 Frequency: Machine sanitation has to be performed every 15 days interval.
8.0 Reference Document
8.1 In House;
9.0 Annexure
9.1 Annexure- I : Format of Machine Log Book
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head of Production or his nominee give the training of technician, production operator and worker.
