Company Name:: VERSION No.

Humanwell Pharmaceutical Ethiopia PLC 1

Title:
Document No: Page No.
SOP/LQ/010 SOP for Operation of bottle labeling machine Page 1 of 4

Effective Date Revision Date

SOP for Operation of bottle labeling

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
 Company Name:: VERSION No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/LQ/010 SOP for Operation of bottle labeling machine Page 2 of 4

Effective Date Revision Date

1. Purpose
This procedure defines the producer for cleaning of filter press

2. Scope

This procedure is applicable to oral liquid filling 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 shift leaders & supervisors to follow the procedure. Quality
assurance manager is responsible for SOP compliance.

5. Material and Equipment

Detergent solution & filter aid

6. Procedure
6.1. Prepare gum by taking gum acacia (suitable quantity required) in a small pot and
add water to it slowly to form a thick paste.
6.2. The amount of water to be added is best decided by operator’s judgment.
6.3. Place the excess gum receptacle on the mount provided for fixing the gum holder.
6.4. Mount the gum receptacle on the rod provided and tighten it with the screw
spring arrangement provided
6.5. Place the rubber roller on the mount provided near the pickup drum taking care
the screw is inserted in the slot provided on the drum.
6.6. Load bottles manually.
6.7. Remove label bundle and check for the QC approval tag : remove few labels and
check them for proper printing of product name etc and correct over printing of Batch
 Company Name:: VERSION No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/LQ/010 SOP for Operation of bottle labeling machine Page 3 of 4

Effective Date Revision Date

No ., Mfg . Date, Exp Date, M.R.P and see that the label conforms to given
specifications.
6.8. Lock the bottles on the conveyor by turning the lock anti- clockwise
6.9. Turn the main switch to the ON position. The red pilot lamp at the push button
station box lights up to indicate machine is ready for operation.
6.10. Start the vacuum by turning the actuator in clock wise directions.
6.11. Press the inching button and adjust the amount of gum required on the roller
by the lock nut screw arrangement provided on gum holder.
6.12. Release the lock on the conveyor and continue to inch to confirm whether the
machine setting is correct.
6.13. Now finally press the push button at the push button station for continues
operation.
6.14. For stopping the machine, press the red switch provided on push button station
box. Turn the vacuum off by Turing the actuator in the anti- clockwise direction
6.15. Turn the main switch to OFF position
6.16. Remove gum roller and gum holder.
6.17. Remove the labels from label box
6.18. Clean the machine thoroughly as per the standard cleaning procedure for labeling
machine

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

Version
Revision Description
No.

1 New
 Company Name:: VERSION No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No: Page No.
SOP/LQ/010 SOP for Operation of bottle labeling machine Page 4 of 4

Effective Date Revision Date