FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

same batch which is to be continued.

Put the Status label on the machine.

5.1.2
5.1.2.1

When new batch of the same product is to be taken on the machine.

Visually inspect the machine and the room for cleanliness. Ensure that there are no
remnants of previous batch. Inform Production Executive / Officer to inspect the machine
and room for cleanliness. Inform QA Chemist / Officer to approve and certify the

5.1.2.2

equipment & room for cleanliness.

Check the tablets (which are to be packed) in the tablet store for batch identity and
Approved Quality Control sticker on each container and bring them into the blister
packing room.

Particulars
Sign.
Date
Name

Prepared By

Checked By

Approved By

Authorized By

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

Blister packing room.

Check that the printing unit is ready along with the stereos of the particular product and

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

When a different product is to be taken on the machine.

Visually inspect the machine and the room for cleanliness. Ensure that there are no
remnants of previous batch. Inform Production Executive/ Officer to inspect the machine
& room for cleanliness. Inform QA Chemist / Officer to approve & certify on the

5.2.2
5.2.3
5.2.4

CLEANED equipment label.

Put the STATUS LABEL on the machine.
Check that the machine is ready for the blister packing of particular product and pack.
Check the tablets (which are to be packed) in the tablet store for batch identity on each

5.2.5

container and bring them into the blister packing room.

Bring the PVC and printed aluminium foil from the packaging material entry air lock to the

5.2.6

Blister packing room.

Check that the printing unit is ready along with the stereos of the particular product and

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

not proceed further till required conditions are obtained.

Check the cleanliness of packing line and its surroundings.

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

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

switch on the chiller.

Select Sealing and Forming heater at ON position in PLC
Check air pressure in main pressure gauge. It should not be less than 6.0 kg/cm2.
Switch 'ON' the top platen heater, bottom platen heater, sealing roller and set the

5.3.5.1
5.3.5.2

temperature and air pressure as mentioned below.

HEATERS
TEMPERATURE
Sealing Heater
180C
Forming Heater
150C

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

stereo should be clear.

Push the 'MACHINE OFF' press button.
Take a piece of printed blister foil having at least 5x2 = 10 prints on it and get it approved

5.4.11
5.4.12
5.4.13

by Production Chemist / Officer and IPQA Chemist / Officer.

Push the 'Machine On' press button.
Push the 'Machine Off' press button after 20 strokes approx.
Pass the sealed web through perforation guide roller, indexing roller and punching tool

5.4.14
5.4.15

and observe for satisfactory cutting and adjust if necessary.

Push the Machine On press button.
Check the sealing, cutting and printing of blisters coming out.

Particulars
Sign.
Date
Name

Prepared By

Checked By

Approved By

Authorized By

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

Switch 'ON' the feeding.

Check the blisters for various quality parameters as specified in the packaging inspection
record.
Perform the leak test.

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

with compressed air and duster.

Film splicing table, Heating plates, Forming plates, Guide plate,

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

cleaned with compressed air and duster.

Clean the machine parts with duster.

Particulars
Sign.
Date
Name

Prepared By

Checked By

Approved By

Dedusting

brush,

Authorized By

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

Production Chemist / Officer.

Put CLEANED label on the machine approved by Production Chemist/ Officer and
IPQA Chemist/ Officer.

5.8

Cleaning during changeover of product with different actives, colour, descending

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

potency Type 'B'.

Switch 'OFF' the machine.
Clean the machine parts using duster.
Remove all the remnants of the previous batch from surrounding area and machine.
Dismantle the following parts of the machine:
Hopper
Vibrator plate
Distributor plate
Dust collecting chute
Feeding channels
Feeding shoe assembly
Dedusting brush
Sealing plates
Clean the sealing plate using cleaning solution (thinner).
Take out the hopper, distribution plate, channel, carry it to the washing area and clean it

5.8.7

by using potable water. Finally rinse with purified water.

Clean the body of the machine using duster dipped in purified water and wipes it with dry

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

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

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

by IPQA Chemist / Officer.

Put 'Cleaned' label and take clearance from QA Dept.

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

Standard Operating Procedure

No.

Number

SS

Stainless Steel

PP

Polypropylene

PVC

Poly Vinyl Chloride

PLC

Programmable Logical Control

BPR

Batch Production Record

IPQA

In Process Quality Assurance

QA

Quality Assurance

Prepared By

Checked By

Approved By

Authorized By

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Blister Packing Machine

Department : Production (General)

SOP No. : IB/BG/05/044

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

07 of 07

kg/cm2 :

Kilogram Per Centimeter square

9.0 REVISION CARD :

Sr.
No.

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

Reason for revision

- Need Based

Authorized By