1.0 Purpose
1.1 To define a standard operating and cleaning of Automatic Cap Sealing Machine.
2.0 Scope
2.1 This procedure is applicable for Automatic Cap Sealing 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.
3.3 Production In-Charge is responsible for proper execution of the SOP.
4.0 Abbreviations and Definitions
4.1 None
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 Main electric power must be off during assembling
6.2 Never clean or work in a running machine
6.3 Collect the breakage glass of the bottle carefully
7.0 Procedure
7.1 Preparation for operation
7.1.1 Check all greasing points.
7.1.2 Make sure the start wheel matches well with
the bottles.
7.1.3 Make sure the cap are smoothly fed,
well-sealed and in good appearance.
7.1.4 Check all screw, nuts are properly tightened.
7.1.5 Make sure that no tools or other foreign
objects are left over inside the machine compartment or on machine table.
7.1.6 Finally, make sure all related parts are
well assembled.
7.2
Operation
7.2.1 Supply power and compressed air to the
system; maintain air pressure at min. 4 Kg/cm2.
7.2.2 Press main power and main motor “ON”, change
switch at low speed.
7.2.3 Check the bottle size matches well with star
wheel pockets.
7.2.4 Check the bottles/star wheel in alignment
with cap sealing head.
7.2.5 Check the sealing head height is matching
with bottles height.
7.2.6 Check the feeding and placing height is
matching with that of bottles.
7.2.7 Place caps in vibrator bowl, fill up to half
of the bowl volume.
7.2.8 Switch vibrator “ON” and adjust intensity to
obtain a suitable feeding speed.
7.2.9 Check
the caps are placed smoothly over the bottles.
7.2.10 Push conveyer “ON” to transport
bottles
7.2.11 Set selector switch at “CONTINUE”
7.2.12 Push main drive “ON”
7.2.13 Start
sealing operation after checking the machine by production Officer and QA
Officer.
7.3 Cleaning
7.3.1 Switch “OFF” the main power supply
connection.
7.3.2 Remove good P.P. caps from hopper, store in
container lined with polythene bag. Clean hopper
with wet clean lint free cloth and then wipe with dry clean lint free cloth.
7.3.3 Remove rejected caps and broken pieces of
glass bottles from the machine.
7.3.4 Remove dust by sparing compressed air.
7.3.5 Open all the change parts of the machine and
clean with wet cloth.
7.3.6 Wash
all the SS parts with Sodium Lauryl Sulfate then wash with purified water.
7.3.7 Water removes with air pressure.
7.3.7 Clean outer surface of machine with wet
clean lint free cloth.
7.3.9 Wipe machine and parts dry with clean
lint free cloth.
7.3.10 Machine operator / worker will request
Production Officer and QA Officer for checking visual
inspection.
7.3.11 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.
7.3.12 Record in Cap Sealing Machine logbook and attach the label of “Cleaned” in the machine.
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.
