STANDARD OPERATING PROCEDURE

TITLE :

HANDLING PROCEDURE FOR CAPSULE FILLING MACHINE

1.0 OBJECTIVE

To lay out the operating procedure for Capsule Filling Machine

2.0 SCOPE

This SOP shall be applicable for to the operating procedure of capsule filler machine.

3.0 RESPONSBILITY

Production Staffs

4.0 ACCOUNTABILITY

Head of Department – Production

5.0 PROCEDURE
5.1 The cleanliness of the area and the equipment should be verified and
“CLEANED” label is patch to the equipment.
5.2 Fill in the details of “Equipment Usage Log”.
5.3 The “CLEANED” label can be remove and replace with the “UNDER
PROCESS” label.
5.4 The Clearance Certificate is retrieved from the In Process Quality Assurance
5.5 Precautions
5.5.1 There should not be any additions, deletion, conversions or
modification be done to the machine.
5.5.2 Never attempt to repair ,clean , or adjust while the machine is in
operation.
5.6 Operation
5.6.1 The handle is fix to the tamping tool using the screws provided and put
to one side.
5.6.2 The body plate is then be placed and fix the feet tightly and squarely to
the under side. Put to one side.
5.6.3 The cap sheet is then be placed on a clean, dry surface.
5.6.4 The encapsulation sheet be placed on top using the stainless steel pegs
to fix it correctly into place.
5.6.5 Then, cover the gap in the wall of the encapsulation sheet with one
hand to avoid spillage.
5.6.6 Pour the capsule tops in. By using a circular motion, gently shake the
tops into the holes.
5.6.7 The excess tops are pour out when the holes are filled.
5.6.8 The encapsulation sheet be removed and put it safely to one side.
5.6.9 If caps are sitting in holes upside down, use another to cap between
two fingers to pluck them out. Put the filled cap sheet to one side.
5.6.10 The bottom sheet is then be taken out. The encapsulation sheet will be
fixed to the bottom sheet, using the stainless steel pegs to fix it
correctly into place.
5.6.11 The capsule bodies is then pour in and shake as before to fill the holes.
Pour off excess capsule bodies.
5.6.12 Remove the filled encapsulation sheet and put it carefully to one side.
5.6.13 If bodies are sitting in the holes upside down, press one side of the
bottom sheet with one hand and use two fingers of the other hand to
turn them over.
5.6.14 Powder guard must be fix to the bottom sheet to prevent spillages.
5.6.15 Pour filling powder on and use the spreader to fill the bottoms.
5.6.16 If the bottoms are not full, remove the powder guard and use the
tamping tool to compress the fillings. Repeat the previous procedure.
5.6.17 The filled cap sheet be taken and place at the middle sheet on top using
the stainless steel pegs to fit it correctly in place.
5.6.18 Turn the cap sheet or middle sheet over and fix to the bottom sheet.
5.6.19 Now, from a standing position, very gently, jiggle the cap sheet or
middle sheet backwards and forwards to connect the capsules.
5.6.20 Exert even pressure downwards.
5.6.21 Turn the whole set over and place both hands on top. Push downwards
to lock the capsules.
5.6.22 Pour out the finished capsules and ready for next procedure for testing
and then packaging procedure.
 5.6.23 Affix “TO BE CLEANED” label on the machine.
5.6.24 The Capsule filling machine be clean as per defined Standard
Operating Procedure.
5.6.25 Records the operation in the log book for documentation.

Prepared By: Date:_____________

William Ching, Consultant

Reviewed By: Date: _____________

Quality Control Laboratory Manager

Reviewed By: Date: _____________

Production Supervisor

Approved By: Date:_____________

Regulatory Affairs/Operations Manager
STANDARD OPERATING PROCEDURE

TITLE :

CLEANING PROCEDURE FOR CAPSULE FILLING MACHINE

1.0 OBJECTIVE

To establish a cleaning procedure for the Capsule Filling Machine

2.0 SCOPE

This SOP shall be applicable for cleaning equipment of capsule filling machine in the
production area. The personnel who are responsible for cleaning capsule filler shall be used
this SOP. Documentation of this activity will be in appropriate batch records or log books.
Removable parts will be cleaned in the Wash Room.

3.0 RESPONSIBILITY

Production Staffs

4.0 ACCOUNTABILITY

Head of Department – Production

5.0 PROCEDURE
5.1 Materials
 Wash sink
 Deionized water
 Shop vacuum
 Scrub brushes
 Approved detergent
 Lint free wipes
 70% IPA
 Batch records

5.2 Safety precautions

 Prior to cleaning, switch off the electric power supply to the machine and
disconnect the electrical cord from the electrical main power supply.
 The compressed air supply to the machine is closed as well as the vacuum
system by disconnecting the pipes for the pneumatic system
5.3 Post fill cleaning
 By using the clean nylon brush and vacuum cleaner, dedust external
surfaces
 The different assemblies and components is dismantled as per procedure
indicated in SOP
5.4 Parts list of dismantled components

Name of Name of Sub-Component

System
Capsule 1. Magazine
Handling Parts: 2. Teflon Guides
3. Pusher Plate
4. Rectifier Race – way block
5. Clamping Plates
6. Empty Capsule Hopper
Powder 1. Tamping Pins
Handling Parts: 2. Bushes
3. Powder Tub with Dosing Disc
4. Blend Feed Pipe
5. Blend Hopper
6. Stirrer, Wiper Block
7. Wiper Plate
8. Guide for Tamping Assembly
9. Tamping Pin Holder
10. Stationary Disc
Other Movable 1. Unopened Assembly
Parts: 2. Collection Box
3. Slug Collection Box
4. Bush Cleaning Unit

5.5 Cleaning of dismantled parts:

 The dismantled parts is transported to the wash room
 Detergent solution dispense into a plugged sink tub
 The component is rinsed with DI water of sufficient quantity to remove
visible dust
 The component is rinsed using warm potable water and the brush is
scrubbed to remove difficult dust
 The component is soaked in detergent solution
 The component is rinsed in DI water to remove detergent
 Each component is wiped with line free wipes soaked in 70% IPA
 The process is repeated for each component

5.6 Cleaning of machine body

 Initially clean with lint free wipes soaked in DI water to remove visible
dust
 Scrub with approved detergent solution by using brush
 Wiped with lint free wipes soaked in DI water to remove detergent
 Wiped with lint free wipes soaked in 70% IPA
 5.7 Drying
 By using dry lint free, the parts is dry and place on clean surface for next
use

6.0 ABBREVIATION

6.1 SOP : Standard Operating Procedure

6.2 IPA : Isopropyl Alcohol
6.3 DI water: Deionized water

Prepared By: Date:_____________

Nur Shairah, Consultant

Reviewed By: Date: _____________

Quality Control Laboratory Manager

Reviewed By: Date: _____________

Production Supervisor

Approved By: Date:_____________

Regulatory Affairs/Operations Manager