Professional Documents
Culture Documents
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
01 of 07
1.0
OBJECTIVE
To lay down a procedure for operation and cleaning of Blister Packing Machine.
2.0
SCOPE
This procedure shall be applicable to operation & cleaning of blister sealing machine,
installed packing area of Beta lactam block.
3.0
RESPONSIBILITY
Production Operators / Chemist / Officer
IPQA Chemist / Officer
4.0
ACCOUNTABILITY
Head - Production
5.0
5.1
5.1.1
5.1.1.1
5.1.1.2
5.1.1.3
PROCEDURE
Pre start up
When the same batch of the same product is to be continued.
Visually inspect the machine and room for cleanliness.
Ensure that previous run was of the same batch number of the same product.
Ensure that all the tablet containers lying in the room are of the same product and of the
5.1.1.4
5.1.2
5.1.2.1
5.1.2.2
Particulars
Sign.
Date
Name
Prepared By
Checked By
Approved By
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
02 of 07
5.1.2.3
Bring the PVC and printed aluminium foil from the packaging material entry air lock to the
5.1.2.4
5.1.2.5
5.1.2.6
batch details.
Load and adjust the PVC film and printed aluminium foil rolls on the specified position.
Adjust the alignment of PVC foil and printed aluminium foil.
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
5.2.8
5.2.9
batch details.
Load and adjust the PVC film and printed aluminium foil rolls on the specified position.
Adjust the alignment of PVC foil and printed aluminium foil.
Check the temperature and relative humidity of the Blister packing room. Record the
same in the BPR. If it is within the specification as per the BPR, continue the operation.
If conditions do not meet the specifications inform the Production Chemist / Officer. Do
5.2.10
5.3
5.3.1
Start up
Put the STATUS LABEL on the equipment.
Particulars
Sign.
Date
Name
Prepared By
Checked By
Approved By
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
03 of 07
5.3.2
Switch 'ON' the main electric supply of machine, open the compressed air valve, and
5.3.3
5.3.4
5.3.5
5.3.5.1
5.3.5.2
5.3.6
5.3.7
5.3.8
5.3.9
5.3.10
Pass the PVC and Blister foil from the specific position to get it sealed.
Keep the feeding switch (located near tablet feeding chute) at 'OFF'.
Switch 'ON' the vacuum pump.
Fill the hopper with tablets manually.
Wet the ink cartridge of printing unit with ink solution.
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
Operation
Keep 'INFEED' switch on manual mode.
Set rotary vibrator frequency.
Check and set the position of sensor to maintain the level of tablets in distributor plate.
Turn the 'INFEED' switch to 'Auto mode'.
Push the 'MACHINE ON' press button.
Slow down the machine speed.
Adjust the tension of foil to remove dismatching.
Set the pressure of ink cartridge and printing roller so that each and every impression of
5.4.9
5.4.10
5.4.11
5.4.12
5.4.13
5.4.14
5.4.15
Particulars
Sign.
Date
Name
Prepared By
Checked By
Approved By
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
04 of 07
5.4.16
5.4.17
5.4.18
5.5
5.5.1
5.5.2
Shutdown
Turn the knob of chiller to 'OFF'.
Push the Red colored press button (located on the control panel) to 'OFF' the main
5.5.3
5.5.4
electric supply.
Turn red regulator OFF.
Close the valves of compressed air.
5.6
5.6.1
Cleaning Procedure
Take out the tablets from the hopper and distributor plate and put them in HDPE
5.6.2
5.6.3
5.6.4
5.6.5
5.6.6
5.6.7
containers lined with double poly bag same batch and close the container properly.
Ensure that no tablets are left in feed track and feeding channels.
Put all the rejected packs into container and put status label on it.
Clean the machine parts using duster.
Clean the upper sealing plate using cleaning solution (thinner) and brush.
Clean the surrounding area of the machine.
Enter the cleaning time in equipment log sheet, sign it and get it counter signed by
Production Chemist/ Officer.
5.7
5.7.1
Cleaning Steps
Hopper, Vibrator plate, Distributor plate, Dust collecting chute, Feeding channels cleaned
5.7.2
5.7.3
5.7.4
Perforation unit, Indexing roller and Punching tool cleaned with compressed air.
Sealing plate using cleaning solution (thinner) and brass brush.
Machine body, Acrylic covers, Control panel machine base and other contact parts
5.7.5
Particulars
Sign.
Date
Name
Prepared By
Checked By
Approved By
Dedusting
brush,
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
05 of 07
5.7.6
5.7.7
5.7.8
5.7.9
Clean the upper sealing plate using cleaning solution (thinner) and brush.
Clean the hopper and distributor plate with duster.
Clean outer portion of the machine by using duster.
Enter cleaning time in the equipment log sheet, sign it and get it counter signed by the
5.7.10
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.8.4.1
5.8.4.2
5.8.4.3
5.8.4.4
5.8.4.5
5.8.4.6
5.8.4.7
5.8.4.8
5.8.5
5.8.6
5.8.7
5.8.8
5.8.9
5.8.10
duster.
Clean the return air filters.
Enter cleaning time in the Machine log.
Inform the IPQA Chemist / Officer to take rinse water sample of hopper, distribution plate
and channel.
Particulars
Sign.
Date
Name
Prepared By
Checked By
Approved By
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
06 of 07
5.8.11
Dry the hopper, distribution plate and channel under infra red air and take them to blister
packing room and assemble these on the blister packing machine after getting approval
5.8.12
5.9
5.9.1
5.9.2
5.9.3
5.9.4
Precaution
Ensure that no blisters with tablets Sealing station during the regular breaks.
Ensure that room is cleaned before the clean and dry parts are brought in.
Ensure that all parts and machine is dry before assembling.
Allow both potable water and purified water to run for one minute before using it for
cleaning.
6.0
REFERENCE (S)
In house
7.0
ANNEXURE (S)
Nil
8.0
Particulars
Sign.
Date
Name
ABBREVIATION (S)
SOP
No.
Number
SS
Stainless Steel
PP
Polypropylene
PVC
PLC
BPR
IPQA
QA
Quality Assurance
Prepared By
Checked By
Approved By
Authorized By
Indchemie
Thana, Baddi
Issue No.
Revision No.
Effective Date
Review Before
Page No.
01
03
05.06.2011
05.06.2013
07 of 07
kg/cm2 :
Date
Revision
No.
Issue
No.
01
25.05.2007
00
01
02
26.05.2009
01
01
- Scheduled Revision
- Need Based
03
23.05.2011
02
01
- Scheduled Revision
- Need Based
Particulars
Sign.
Date
Name
Prepared By
Details of revision
- Footer of SOP is revised
As per SOP No. IB/QA/05/001.
Checked By
Approved By
Authorized By