FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for operation and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

01 of 06

1.0

OBJECTIVE
To lay down a procedure for operation and cleaning of paam automatic capsule filling
machine (AF90T).

2.0

SCOPE
This procedure shall be applicable to operation and cleaning of paam automatic capsule
filling machine (AF90T).

3.0

RESPONSIBILITY
Production Operator/ Chemist/Officer
IPQA chemist/Officer

4.0

ACCOUNTABILITY
Head - Production

5.0

PROCEDURE

5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.1.7
5.1.8
5.1.9

PRESTART UP
Wear clean nose mask and hand gloves.
Check the availability of compressed air.
Check the previous status label.
Check the area & machine for cleanliness.
Ensure the temperature (NMT 25C) & RH (NMT 55%) and record the same in BPR.
Ensure the line clearance from Q.A.
Ensure the machine for proper setting.
Ensure the label of blend to be filled.
Ensure the status label of upcoming product.

5.2
5.2.1

OPERATION
Turn the machine 2-3 cycles manually after setting the hand wheel for correct position to

5.2.2

make sure all moving parts work properly before turning it on by power.
Turn the valve in ON of main compressed air supply.

5.2.3

Turn the main switch ON.

Particulars
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Date
Name

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FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for operation and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

02 of 06

5.2.4

Turn the machine 12-20 cycles without capsules and powder for the initial start up.

5.2.5

5.2.7

Fill the powder hopper with the blend material by turn the main switch ON of Powder
loader.
Fill the dosing chamber with the blend material by depressing the button for manual
feeding.
Fill the capsules into the hopper & reservoir by capsule loader switch ON

5.2.8

On PLC, keep it on Auto mode & press for ON position.

5.2.9

Keep0 at counting mode before starting the machine.

5.2.10

Ensure when all parameters like powder supply, capsule supply ,vacuum supply, capsule

5.2.11

shutter, dust collector and buzzer sound are on, its shows green color
Set the Polishing machine & Mini filled capsule sorter at the end of discharge unit.

5.2.12

Set the proper level of the powder bed height by powder sensor.Check the capsule fill

5.2.6

weight and adjust the fill weight, if needed, by decreasing or Increasing the penetration of
5.2.13

the tamping pin.

Check the required locking length as per BPR by using vernier calliper .

5.2.14

Collect the good capsule in cleaned container at the discharge of sorter.

5.2.15

Record the operational details in Equipment Log Book.

CAUTION
Ensure that air handling units and dust extraction units are always ON during the entire
operation of capsule filling activity. In case the air handling units and dust extraction units
stops functioning, stop the machine immediately and inform the engineering department
for corrective actions.

5.3

CLEANING

5.3.1

For the same product

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 and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

03 of 06

5.3.1.1

Clean the empty capsule hopper, powder hopper, screw feeder, tamping pins, scraper
plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass plate,
discharge unit, locking unit, faulty capsule ejection unit, segment cleaning assembly ,

5.3.1.2

vacuum bush,by using vacuum cleaner followed by dry and clean duster.
Clean all the viable surfaces with help of Vacuum cleaner.

5.3.1.3

Ensure complete removal of powder & capsules from the platform of the machine.

5.3.1.4

Wipe & clean with a dry and clean duster or lint free cloth.

5.3.1.5

Affix CLEANED label on the machine.

5.3.1.6

Record the cleaning details in Equipment Log Book.

5.3.2

For the different product

Note : While washing, remove sensors from peripheral

parts of minimum and

5.3.2.1

maximum powder level

Ensure complete removal of powder & capsules from the platform of the machine.

5.3.2.2

Dismantle the empty capsule hopper, Powder hopper, screw feeder, tamping pins,
scraper plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass
plate, discharge unit, locking unit, Faulty capsule ejection unit, segment cleaning
assembly , vacuum bush and wash it approx 50-60 liter of portable water. Rinse all

5.3.2.3

washed parts with by approx 40 liters of Purified water and dry by using jet of air.
Vacuum clean all the viable surfaces.

5.3.2.4

Wipe the tower portion with cloth damped with Purified water.

5.3.2.5

Blow with oil, moisture & dirt free compressed air.

5.3.2.6

Clean the lower portion similarly with cloth damp with Purified water and dry by blowing
with oil, moisture & dirt free compressed air.

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 and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

04 of 06

5.3.2.7

Assemble the empty capsule hopper, Powder hopper, screw feeder, tamping pins,
scraper plate, dosing disc, upper and lower segment magazine, rectifier blocks, brass
plate, discharge unit, locking unit, faulty capsule ejection unit, segment cleaning

5.3.2.8

assembly, vacuum bush and check the machine for correct setting by empty run.
Send Swab / rinse sample for analysis to QC.

5.3.2.9

Affix CLEANED tag on the machine.

5.3.2.10

Record the cleaning details in Equipment Log Book.

6.0

REFERENCE (S)
In house

7.0

ANNEXURE (S)
Nil

8.0

ABBREVIATION (S)
SOP :

Standard Operating Procedure

No.

Number

BPR :

Particulars
Sign.
Date
Name

Batch Production Record

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 and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

05 of 06

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

26.05.2011

02

01

- Scheduled Revision

- Need Based

Particulars
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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

FOR RESTRICTED CIRCULATION ONLY

Indchemie

Health Specialities Pvt. Ltd.

Thana, Baddi

STANDARD OPERATING PROCEDURE

Title:

Procedure for operation and cleaning of paam automatic capsule filling machine
(AF 90T)

Department : Production (Capsule)

SOP No. : IB/BC/05/002

Revision No.

Effective Date

Review Before

Page No.

04

05.06.2013

05.06.2016

06 of 06

04

27.05.2013

Particulars
Sign.
Date
Name

03

Prepared By

--

- Remove issue no. & addition

of water quantity for cleaning

Checked By

Approved By

Need Based

Authorized By