FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

1 of 6

1.0

OBJECTIVE
To lay down a procedure for operation and cleaning of Strip Packing Machine.

2.0

SCOPE
This procedure shall be applicable to operation & cleaning of strip 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

PROCEDURE
Pre start up
For same batch of the same product.
The Production Chemist / Officer shall visually inspect the machine and room for

5.1.1.2
5.1.1.3
5.1.1.4

cleanliness.
Ensure that previous run was of the same batch number of the same product.
Ensure that the material lying in the room is of the same batch which is to be continued.
Check the temperature and relative humidity of the area and record it in the
environmental control record. If it is within the specification as per the BPR, continue the
operation. If not, do not start the operation and inform the Production Executive / Officer

5.1.2
5.1.2.1

or Maintenance Executive / Officer.

For new batch of the same product.
The Production Chemist / Officer shall visually inspect the machine and the room for

5.1.2.2

cleanliness. Ensure that there are no remnants of previous batch.

Inform the IPQA Chemist / Officer to approve and certify the clean equipment and clean

5.1.2.3
5.1.2.4

room.
Affix the "CLEANED" on equipment & put the "STATUS LABEL".
Check the released material (which is to be taken on the machine) for batch identity and
bring them in the strip packing room from the tablet store.

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 Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

2 of 6

5.1.2.5

Check the temperature and relative humidity of the area and record it in the
environmental control record. If it is within the specification as per the BPR, continue the
operation. If not, do not start the operation and inform the Production Executive / Officer
or Maintenance Executive / Officer.

5.1.3
5.1.3.1
5.1.3.2

For different product is to be taken on the machine.

Check the Rinse Water Sample Analysis Report.
The Production Chemist / Officer shall visually inspect the machine and the room for
cleanliness. Ensure that there are no remnants of previous product. Ensure approval of

5.1.3.3
5.1.3.4

IPQA Chemist / Officer on the clean equipment and clean room.

Affix the "CLEANED" on equipment & put the "STATUS LABEL".
Check the released material (which is to be taken on the machine) for batch identity and

5.1.3.5

bring them in the strip packing room from the tablet store.
Check the temperature and relative humidity of the area and record it in the
environmental control record. If it is within the specification as per the BPR, continue the
operation. If not, do not start the operation and inform the Production Executive / Officer
or Maintenance Executive / Officer.

5.2
5.2.1

Start up
Check that the machine is set with the specified change parts for the strip packing

5.2.2

machine of a particular product and pack size.

Load and clamp the printed and plain aluminium foil on the specified position and adjust

5.2.3
5.2.4

its alignment.
Check that the printing unit is ready along with stereos of that particular batch details.
Take out the print of the stereos on the foil and check it against the batch details as per
BPR. Get it signed from Production Chemist / Officer and IPQA Chemist / Officer and
attach it in the BPR.

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 Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

3 of 6

5.2.5

Check the temperature and relative humidity of the area and record it in the
environmental control record. If it is within the specification as per the BPR, continue the
operation. If not, do not start the operation and inform the Production Executive / Officer

5.2.6
5.2.7

or Maintenance Executive / Officer.

Switch 'ON' the main electric supply.
Switch 'ON' the heaters and adjust the thermostat as per the requirement.

5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7

Operation
Fix the channel on the strip packing machine.
Load the tablets into hopper of strip packing machine.
Check that the rollers have attained the desired temperature on digital display.
Switch 'ON' the machine and start feeding the tablets through channel.
Check the packing and printing of strips from the machine.
Check the Leak Test at regular intervals.
Continue strip packing operation till the end of the shift / completion of the batch.

5.4
5.4.1
5.4.2
5.4.3

Shutdown
Switch 'OFF' the machine.
Switch 'OFF' the main electric supply.
Take out the tablets left in the hopper, bowl and channel and keep them in HDPE
containers.

5.5
5.5.1

Cleaning Procedure
Cleaning at the end of the shift / batch changeover of same product / strength,

5.5.1.1
5.5.1.2
5.5.1.3
5.5.1.4

change in ascending order (provided colour is same) - Type 'A'.

Switch off the machine.
Remove the stereos from the roller and destroy in case of batch changeover.
Affix 'TO BE CLEANED' label on the equipment.
Remove all the remnants of the previous batch / product from the surrounding area and

5.5.1.5
5.5.1.6
5.5.1.7
5.5.1.8

machine in case of changeover.

Clean the hopper with duster / vacuum cleaner.
Clean the bowl with dry & clean duster or lint free cloth.
Clean the channel using compressed air in equipment wash.
Clean the sealing roller with brass brushes.

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 Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

4 of 6

5.5.1.9
5.5.1.10
5.5.1.11

Clean the rest of the equipment body using duster / vacuum cleaner.
Clean and mop the floor.
Put "STATUS LABEL" on the equipment and record the cleaning details in Equipment
Log Book.

5.5.2

Cleaning during changeover of product with different actives colour, descending

5.5.2.1
5.5.2.2
5.5.2.3
5.5.2.4
5.5.2.5

potency - Type 'B'.

Switch off the machine.
Affix 'TO BE CLEANED' label on the equipment.
Remove the stereos from the roller and destroy.
Dry clean the equipment using vacuum cleaner and dry & clean duster or lint free cloth.
Take out hopper, bowl, and channel and take these to the equipment wash area and

5.5.2.6
5.5.2.7
5.5.2.8
5.5.2.9
5.5.2.10
5.5.2.11
5.5.2.12
5.5.2.13

wash with potable water. Finally rinse with Purified Water.

Request IPQA Chemist / Officer to collect rinse water sample and dry them using duster.
Arrange for the cleaning of strip packing room.
Arrange for cleaning of the filters of return riser.
Take all the parts to the strip packing machine and assemble these on the machine.
Assemble return air filters in the room.
Clean the sealing rollers with brass brushes.
Clean and mop the floor.
Put "STATUS LABEL" on the equipment and record the cleaning details in Equipment
Log Book.

5.6
5.6.1
5.6.2
5.6.3

Precaution
Ensure that no tablets remain in between sealing rollers during the regular breaks.
Remove the channel assembly during the breaks.
Do not start the operation till the specified temperature and relative humidity specified in

5.6.4

the BPR are obtained.

Do not start the machine without safety guard of roller and cutters.

6.0

REFERENCE (S)
In house

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 Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

5 of 6

ANNEXURE (S)

7.0

Nil
ABBREVIATION (S)

8.0

SOP :

Standard Operating Procedure

No.

Number

BPR :

Batch Production Record

IPQA :

In Process Quality Assurance

9.0 REVISION CARD :

Sr.
No.

Date

Revision
No.

Issue
No.

01

25.05.2007

00

01

02

26.05.2009

01

01

Particulars
Sign.
Date
Name

Prepared By

Details of revision
- Footer of SOP is revised
As per SOP No. IB/QA/05/001.
- Scheduled Revision

Checked By

Approved By

Reason for revision

- Need Based
- Need Based

Authorized By

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for Operation & Cleaning of Strip Sealing Machine

Department : Production (General)

SOP No. : IB/BG/05/043

Issue No.

Revision No.

Effective Date

Review Before

Page No.

01

03

05.06.2011

05.06.2013

6 of 6

03

25.05.2011

Particulars
Sign.
Date
Name

02

Prepared By

01

- Scheduled Revision

Checked By

Approved By

- Need Based

Authorized By