Standard Operating Procedure Confidential and Proprietary

SOP No.
Revision No.

Page No.
New

DEPARTMENT:
SECTION:
SUBJECT:

Supersedes

Page 1 of 3
N/A

Date Issued
Date Effective

Production
Research and Development, Production
Operation of the Semi-Automatic Capsule Filling Machine (Model JTJ-C)

1.

Purpose:

To list the manually manipulated parts and describe proper operating procedure
for routine operation and troubleshooting of the Semi-Automatic Capsule Filling
Machine (Model JTJ-C)

2.

Copies To:

Production Department

3.

Abbreviations:

None

4.

Responsibility:

Production Department Head, Production Personnel, In-Process Quality

Control Personnel

5.

Materials/Equipment:

None

6.

Reason/s for Revision/s:

None

7.

Parts:
7.1
7.2
7.3
7.4
7.5
7.6
7.7

8.

Water inlet, water outlet, air outlet

Capsule hopper
Pair of mould
Capsule conveying body
Thimble disk
Pedal air valve
Control panel

Process Descriptions:
8.1 Starting Operation
Refer to the installation document of this equipment.
8.2 Routine Operation
8.2.1
Reminders
8.2.1.1
8.2.2
Identify and secure appropriate capsule shells as product specification.
8.2.3
Take note the products lot number and expiry date for coding.
8.2.4
Ensure that the moving parts of the machine are sufficiently oiled before cleaning.

Prepared by:
Checked by:
ALBERT ERADIO
Production Head
Date:
Date:
March 16, 2014
Review date on or before 12 months from the date of authorization

Authorized by:
Date:

Standard Operating Procedure Confidential and Proprietary

SOP No.
Revision No.
DEPARTMENT:
SECTION:
SUBJECT:
8.2.5
8.2.6
8.2.7
8.2.8
8.2.9
8.2.10
8.2.11
8.2.12
8.2.13
8.2.14
8.2.15
8.2.16
8.2.17
8.2.18
8.2.19
8.2.20
8.2.21
8.2.22
8.2.23
8.2.24
8.2.25
8.2.26
8.2.27

Page No.
New

Supersedes

Page 2 of 3
N/A

Date Issued
Date Effective

Production
Research and Development, Production
Operation of the Semi-Automatic Capsule Filling Machine (Model JTJ-C)
Clean the Encapsulating area, the machine and corresponding moulds. Refer to document PDCEncap for the cleaning procedure.
After cleaning, install the moulds in their proper places in the machine as illustrated in Figure#.
Accomplish the Cleaning Checklists.
Secure line clearance from the In-Process Quality Control personnel: filled and posted CLEAN
tag.
Record the areas relative humidity at the earliest of the following times: 9am, 11am, and 4pm.
Record areas working room temperature.
Turn on the cooling waters main switch.
Note: The valves of the water inlet and outlet should remain closed until the operation is about to
start.
Ensure availability of compressed air supply.
With the clutch in the ON position, check the correctness of the capsule-sowing mechanism
setting manually. Perform necessary adjustments.
Fill the hopper with capsule shells. Use the stainless scoop to approximate quantity.
Run the machine manually to check if the capsules enter the ring correctly. Perform the necessary
adjustments.
Switch the power breaker on and press the machines power button.
Ensure that the vacuum pressure is not less than 600mmHg.
Start the machine and move the clutch lever to the right to bring the capsule sowing mechanism in
action. If the loading of capsules is already satisfactory, complete the loading of the whole disc.
The machine should stop automatically after each loading is complete. Rotate the discs together
manually in counterclockwise direction for 2-3 times to provide the capsules additional exposure
to vacuum for effective separation of the bodies from the caps.
Lift the top half disc to chest level to check for effective separation.
8.2.20.1 Correct unseparated capsules manually.
8.2.20.2 Increase the vacuum pressure if too many capsules are found unseparated.
Once the loading and separation of capsules are satisfactory, repeat the process with another ring
assembly while filling mechanism is accomplished (discussed in succeeding steps).
Place the top half disc on standby in the locking station while waiting for the filled capsule bodies.
Place the bottom half of the disc on the turn-table of the filling station.
Refer to the Encapsulating Area Operation Logbook to set the filling speeds of the turn table and
the auger suitable for the product specification.
Fill the drug hopper with the powder up to the stirring arm.
Turn the filling mechanism on to start the filling mechanism.
Once the filling of the whole disc is completed, the machine should automatically stop.

Prepared by:
Checked by:
ALBERT ERADIO
Production Head
Date:
Date:
March 16, 2014
Review date on or before 12 months from the date of authorization

Authorized by:
Date:

Standard Operating Procedure Confidential and Proprietary

SOP No.
Revision No.
DEPARTMENT:
SECTION:
SUBJECT:
8.2.28
8.2.29
8.2.30
8.2.31
8.2.32
8.2.33
8.2.34
8.2.35
8.2.36
8.2.37

Page No.
New

Supersedes

Page 3 of 3
N/A

Date Issued
Date Effective

Production
Research and Development, Production
Operation of the Semi-Automatic Capsule Filling Machine (Model JTJ-C)
Scrape off excess powder from the top of the disc with a clean scraper.
Remove the half disc containing the filled capsule bodies carefully from the filling turn-table.
Enjoin it with the disc previously installed in the locking station.
Prior to locking of the capsules, it is recommended to recheck if the compressed air supply is
sufficient. Adjust if necessary.
Using one foot, lock the two discs together by pushing the pedal air valve on the lower part of the
machine, parallel to the locking station.
Once the characteristic click, indicating locked capsules, is already heard, push the discs against
the thimble disc to eject locked capsules.
Sample these filled capsules to check for the weight compliance as per product specification.
Perform necessary adjustments on the filling mechanism speeds to correct for weight.
Once satisfactory filled capsule weight is achieved, repeat the whole process from capsule sowing
to locking until the batch size is completed.
Weigh the total resulting filled capsules for the batch.
Collect all excess powder in the designated plastic for bulk weighing.

9. Reference/s: Semi-Automatic Capsule Filling Machine Operation Manual

10. History:
None
11. Attachments: None
12. End of document

Prepared by:
Checked by:
ALBERT ERADIO
Production Head
Date:
Date:
March 16, 2014
Review date on or before 12 months from the date of authorization

Authorized by:
Date: