SOPs

OPERATION OF 27 STATION DOUBLE ROTARY TABLET COMPRESSION MACHINE

ABHA

1) OBJECTIVE

To define procedure and steps to be carried out for the operation of 27 stations double rotary tablet compression machine
2) SCOPE
This SOP is applicable for the operation  of 27 stations double rotary tablet compression machine
3) RESPONSIBILITY
Operator:  To operate the equipment as per the given procedure.
4) ACCOUNTABILITY
 Production Officer: To check and monitor the operating activity and record the same.
5) REFERENCES
In- House
6) ATTACHMENTS
Annexure – I ( Machine Log Book )
7) COMMENTS
7.1    SOP reviewed at the end of the Review Period.

7.2    SOP revised due to change in the Review period of SOP from 2 years to 3 years.

8) PROCEDURE
8.1Ensure that the Equipment and the Area are released by the Quality Assurance Department for production.
8.2Ensure that the power mains are switched ‘OFF’.
8.3Open the left side SS cover to expose the lower punch loading position.
8.4Rotate the machine flywheel ( by hand ) to bring one of the stations in the turret directly above the punch loading position.
8.5Clean the holes & insert dies in each of them. Press the same with the help of die rod ( in case of DS shape tooling the upper punches are to be set before fixing the dies aligning with the upper punches ).
8.6The dies are tightened with Teflon plugs and align cylindrical bolts. The lower punches are from the bottom.
8.7Held the lower punch tightly with anti–turning strips and Teflon plumps.
8.8Adjust the lower punch height such that on the ejection at the height point the punch surface flushes with the turret die surface. This will eject the tablet freely.
8.9On completion of lower punches fixing, fix the feed frame on both left & right.
8.10Fix both the hoppers on the left & right to the spindles provided.
8.11Fill the hopper with product granules ( to be compressed ) and rotate the flywheel slowly. This will enable the granules to flow down the hopper and into the die holes, 2nd & 3rd ports of the feed frame.
8.12Adjust the hopper in such a way that the granules flow freely down.
8.13Adjust the tablet weight ( which is related to the die fill volume ) by adjusting the stop screw with the handle, which in turn alters the travel of the dozer on whose surface the lower punch’s heads travel. In the process, the scraper blade fixed to the feed frame scrapes off the excess granules.
8.14Adjust the tablet hardness by pressing the adjusting handwheel, which raises or lowers the lower pressure rolls to increase or decrease the distance between the upper and lower punch faces. Reduction of distance will increase the pressure and vice – versa.
8.15After setting and obtaining the desired weight and hardness continue the compression.
8.16On completion of the operation, label the equipment suitably for further use/cleaning. Clean the machine as per cleaning SOP.
9)ABBREVIATIONS:
SOP: Standard operating procedure
QA: Quality Assurance
QC: Quality Control
PD: Production Department

MACHINE LOG BOOK

MACHINE:MACHINE NO.:
LOCATION:MAKE:
CLEANING SOP NO.:OPERATION SOP NO.:
DateProductB.No.ActivityTimeDone

By

Breakdown hrsNature of      Break downChecked

By

Remarks
FromToFromTo

 

 

 

 

 

 

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube