1.0 Purpose
1.1 To define a standard operating and cleaning procedure of Automatic Liquid Filling Machine.
2.0 Scope
2.1 This procedure is applicable for Automatic Liquid Filling 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 None
5.0 Materials and Equipment
5.1 Nylon scrubber
5.2 Hard nylon brush
5.3 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 Take all precautions during dismantling and assembling piston so that no parts get damaged.
7.0 Procedure
7.1 Preparation for operation
7.1.1 Set the guide rails as per the bottle so
that the neck of the bottle moves below the nozzles freely and minimum clearance.
7.1.2 Set the position of the front stopper such
that four bottles are set centrally. Set the rear stopper away by four bottles from the front stopper.
7.1.3 Set the nozzles at the center of the
respective bottles.
7.1.4 Set the diving stroke and position such that
the top position is about 20 to 40 mm above bottle neck and lower position on the frothing characteristics of the
liquid.
7.2 Operation
Procedure
7.2.1 Check all the part of Machine is clean and
dry.
7.2.2 Make sure all related parts are correctly
assembled.
7.2.3 Make sure that no tools or other foreign
objects have been left over on the machine surface or compartment.
7.2.4 Check conveyer guide rods and well-
adjusted.
7.2.5 Switch “ON” the main power supply
connection.
7.2.6 Arrange the bottle on the turn-table and start
it.
7.2.7 Adjust the nozzles and bottle by starting
conveyer belt for smooth filling operation of the liquid.
7.2.8 Connect the pipe line to liquid storage
vessel.
7.2.9 Adjust the filled volume of liquid.
7.2.10 Check the machine by Production Officer first
and then by QA Officer.
7.3 Cleaning Procedure
7.3.1 Affix the “To Be Cleaned” label.
7.3.2 Remove hose pipes between storage tank and piston and hose pipes between piston and nozzles.
7.3.3 Remove all pistons from machine and filling nozzles from bracket and keep them in SS container / SS bucket.
7.3.4 Rinse the hose
pipes first with potable water, then with purified water. Finally clean all hose
pipes thoroughly with hot purified
water (75 ⁰ C).
7.3.5 Dismantle all
parts of piston. Clean all parts of piston and nozzle first with potable water, then with sufficient qty. of detergent
solution (0.4 % w/v, sodium lauryl sulphate) thoroughly
using hard nylon brush and again clean with purified water
to remove all the traces of detergent
solution.
7.3.6 Clean all parts of
piston and nozzles thoroughly with purified water check physically for the absence of traces of detergent solution
in final rinse water.
7.3.8 Open outlet of
liquid storage tank. Rinse tank with potable water, then clean with sufficient quantity of Detergent
Solution (0.4 % w/v sodium lauryl sulphate) using nylon scrubber and again with potable water. Finally clean tank
thoroughly with purified water.
7.3.9 Clean outer
surface of machine twice with clean wet cloth and then wipe with dry clean lint
free cloth.
7.3.10 Wash the S.S.
conveyer belt first with potable water then with Detergent solution (0.4 % w/v, sodium
lauryl sulphate) using nylon scrubber and again with potable water, finally
rinse thoroughly with purified
water and wipe dry with lint free cloth.
7.3.11 Remove the water
from the surface of the parts with dry lint free cloth.
7.3.12 Before machine operation, it is mandatory to run machine with hot purified water (75⁰ C) at least 10 minutes.
7.4 Machine operator / worker will request
Production Officer and QA Officer for checking visual
inspection.
7.5 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. 6 Record in Liquid Filling Machine logbook
and attach the label of “Cleaned” in the machine.
7.7 After
cleaning the Liquid Filling Machine 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.
