Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

Title:
Document No:
SOP/OS/003
CLEANING AND ASSEMBLY OF COMPRESSION Page No.
Page 1 of 5
MACHINE
Effective Date Revision Date

CLEANING AND ASSEMBLY OF COMPRESSION

MACHINE

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/OS/003
CLEANING AND ASSEMBLY OF COMPRESSION Page No.
Page 2 of 5
MACHINE
Effective Date Revision Date

This procedure defines the cleaning procedure for tablet compression machine. For the
smooth and efficient working of the compression machine, it is necessary that the machine is
cleaned and assembled with utmost care by the trained personnel. Periodically, various parts
of the machine need critical inspection for wear and tear. A written producer for cleaning and
assembly of the compression machine helps substantially to keep a check on the quality of
various parts as well as ensures trouble free working of the machine.

2. Scope

This procedure is applicable to all tablet compression machines in Humanwell

Pharmaceutical Ethiopia PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the compression operators and supervisors to follow the
procedure. Quality assurance manager is responsible for SOP compliance.

5. Material and Equipment

Nylon brush and special denatured spirit

6. Procedure
6.1. Disassembling
As soon as the compression of particular batch is over, clean the entire exterior of the
machine as well as the room. Following procedure will be adhered to:
i. Disconnect the electric supply.
ii. Dismantle carefully the following parts.
 feed hoppers
 Acrylic guards
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/OS/003
CLEANING AND ASSEMBLY OF COMPRESSION Page No.
Page 3 of 5
MACHINE
Effective Date Revision Date

 Feed-frames
 Turret guards
 Cover plat of the worn shaft
 Nylon break plugs along with, the spring steel strips
 Die screws
 Tablets collecting chutes
 Dust collecting hood assembling
6.2. Cleaning
6.2.1. Clean all the above mentioned parts along with relevant bolts thoroughly with hot tap
water and keep them aside.
6.2.2. Remove carefully all the lower punches by removing the plug and keep these punches in
a specially designed wooden tray, serially arranged. Similarly remove all the upper
punches and keep them separate wooden tray serially arranged. Remove all the dies with
the help of a SS rod and keep them serially arranged in one of the above trays.
6.2.3. Clean all the interior area of the machine like base plat on which the turret is fitted, came
trucks, die seats, upper and lower punch holes, and turret surface. First with a dry nylon
brush and then with special denatured spirit. Care should be taken while cleaning the
punch hole and die seats so that they are free from any participate matter.
6.2.4. Wipe clean the exterior of the machine with a lint free duster soaked in special denatured
spirit.
6.2.5. Get the entire area cleaned by the janitor.
6.2.6. Cleaning the fitting of punches and dies.
Teak about 2 liter of hot tap water, 10% teepol (nontoxic detergent solution) mixture and
clean all the punches by dipping each in hot water teepol mixture and then cleaning
thoroughly with hot tap water. After cleaning, all the punches and dies should be put
serially in the clean wooden trays meant for storing them.
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/OS/003
CLEANING AND ASSEMBLY OF COMPRESSION Page No.
Page 4 of 5
MACHINE
Effective Date Revision Date

Use 15 liters of distilled water to give couple of washes to the cleaned parts and the
dismantled punches and dies. Inspect the final rinse water for absence of my suspended
matter. If required, use additional distilled water to get the ‘’clear’’ rinse water.
6.2.7. Wipe all the cleaned Parts from step f ‘with a clean dry lint free cloth.
6.3. Assembling
6.3.1 FITTING OF DIES

Before the dies are fitted, ensure all the die seats are free from any matter. Place the die face
downwards on the die hole. Apply light pressure with fingers on the top phase of the die to
locate centrally over the die hole. After locating the die correctly, Drive the die in to its
position with the help of SS rod introduced through the upper punch guide holes. Once the
die is fitted, the top portion of the die should flush with the turret surface. Now introduce all
the die screw and tighten again. Check whether the die surface flush with the turret surface.

6.3.2. FITTING OF LOWER PUNCHES

Teak a lower punch, wipes it dry, smear with liquid paraffin and introduce it through the
lower punch die hole taking care that each numbered punch goes into its corresponding
cooperation station. All the lower punches thus introduced should move up and down. put the
plug back in to its position. Fix all the cleaned and dried nylon plugs with spring steel strips.

6.3.3. FITTING OF UPPER PUNCHES

The cleaned and dried upper punches should be smeared with liquid paraffin and introduced
into their corresponding holes.

6.3.4. Put back all the turret guards after wiping them dry. Fit the cleaned and dried feed frame
at their respective position. Installed the cleaned and dried acrylic guards and hoppers in
their relevant positions.
6.3.5. Assembling the cleaned dust collecting hood assemblies
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/OS/003
CLEANING AND ASSEMBLY OF COMPRESSION Page No.
Page 5 of 5
MACHINE
Effective Date Revision Date

6.3.6. Cover the cleaned machine with a clean cloth cover. Affix a cleaning ticket indicating the
following:
- Equipment/Machine
-Last product Lot no. -
-Cleaned and ready for product- Lot no. –
- Cleaned by
- Date
-supervisor’s signature

7. Abbreviations:
SOP Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History

Version
Revision Description
No.

1 New