Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

Title:

Document No: OIL APPLICATION PROCEDURE FOR Page No.

SOP/OS/013 Page 1 of 3
COMPRESSION TOOLS & MACHINE

Effective Date Revision Date

OIL APPLICATION PROCEDURE FOR COMPRESSION

TOOLS & 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: OIL APPLICATION PROCEDURE FOR Page No.

SOP/OS/013 Page 2 of 3
COMPRESSION TOOLS & MACHINE

Effective Date Revision Date

This procedure defines the requirements for oil application to tablet compression machines
and tooling which include dies and punches.

2. Scope
This procedure is applicable to tablet compression machine and tooling tablet line 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 operators to follow the procedure. Quality assurance
manager is responsible for SOP compliance.

5. Material and Equipment

Food grade oils

6. Procedure

6.1. COMPRESSION TOOLS (DIES and PUNCHES)

6.1.1. After cleaning the dies and punches, take 10 ml of thick oil can in to one tray.
6.1.2. Apply this smear on punch head, tip and body.
6.1.3. Insert the punches in to the respective holes Protecting tip portion.
6.2. COMPERATION MACHINE
6.2.1. After setting of the dies and punches, oil the upper cam track with about 10 drops
of oil.
6.2.2. On each upper pressure roller, put approximate 10 drops of oil.
6.2.3. With help of oil can, oil the lower punch heads and cams (apply about 20 ml oil).
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:

Document No: OIL APPLICATION PROCEDURE FOR Page No.

SOP/OS/013 Page 3 of 3
COMPRESSION TOOLS & MACHINE

Effective Date Revision Date

6.2.4. Before starting the machine, open the oil cups provided and adjust the oil flow to
4 drops per minute. Start the machine and after 15 minutes stop the oil flow.
Repeat after every 2 hours.
6.2.5. For all cooperation machines, use one stroke oil pump so as to lubricate pressure
roles and pins.

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

Version
Revision Description
No.

1 New