sop for operation and cleaning of double rotary compression machine

1.0 Purpose
1.1 To lay down a procedure for Operation and Cleaning of Double Rotary Compression Machine.
2.0 Scope
2.1 This SOP is applicable for Operation and Cleaning of Double Rotary Compression Machine in A B C Pvt. Ltd.
3.0 Responsibility
3.1

Machine Operator	To execute the procedure.
Production & QA officer	Follow the procedure as per SOP
Head Production	Training and Implementation of SOP

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Pre-Startup
5.1.1 Check the line clearance of the area.
5.1.2 Check the material lying in the compression room is of the same batch to be proceeding.
5.1.3 Update the status board.
5.2 Operation
5.1.1 Precautions
5.1.1.1 Ensure that the operators are trained.
5.1.1.2 Check that the punches are free in upper punch guides and drop under their own weight.
5.1.1.3 Check that all oil reservoirs and lubricators are filled up to correct level.
5.1.1.4 Check that required dust extractor & Dedusting units are connected and are in working condition.
5.1.1.5 Check that Upper Punches are freely moving in the Guide Hole by raising and lowering.
5.1.2 Machine operation
5.1.2.1 Switch ON the main electrical supply
5.1.2.2 Load the granules to be compressed into the hopper.
5.1.2.3 Ensure that the alignment of dies and punches, feed frame, hopper is done

properly; .if found satisfactory run the machine by inching for 2-3 rotation
5.1.2.4 Set the required physical parameters of the compressed tablet as per the batch manufacturing instruction
5.1.2.5 Adjustment for tablet making should be carried out to maximum safe pressure, adjust

to correct thickness without over loading and also to obtain correct weight.
5.1.2.6 Fill hoper with material to be compressed, adjustment of material flow in to the feed

frame is achieved by varying the height of hopper spout above the die table.
5.1.2.7 Adjust weight of tablets by weight control spindle. Rotate in an anti clockwise direction

for decreasing and clockwise direction for increasing the weight of tablets on both sides.
5.1.2.8 Provide sufficient pressure by rotating pressure wheel in clockwise direction for decreasing

and in an anti clockwise direction for increasing the pressure.
5.1.2.9 Set & check all control parameters as per Batch Manufacturing Record. Run

the machine in auto mode and check average weight, weight variation, thickness, hardness

and adjust properly to bring results as per specification. Discard initially compressed tablets.
5.1.2.10 Place double polyethylene lined clean HDPE containers at the outlet of Dedusting

machine to collect the tablet.
5.1.2.11 Perform checks for physical parameters for both sides tablets as per

Batch Manufacturing Record and record it in BMR.
5.1.2.12 Run the compression machine in auto mode.
5.1.2.13 De-dusting machine is to be started before running the compression machine
5.1.2.14 Increase the machine RPM as per output require. When the RPM of machine

increases or decreases check and adjust parameter as per specification again.
5.1.2.15 Weigh the individual container containing compressed tablets and record

the same in the Batch Manufacturing Record.
5.1.2.16 Tie the compressed tablets poly bags with cable tie & transfer all the drums to the tablet quarantine.
5.1.2.17 After completion of compression, remove left over & affix the status label “To be cleaned”.
5.1.2.18 Record the activity in Equipment Log and respective BMR.
NOTE: Do not run the compression machine without powder in the feed frame.
5.3 Cleaning
5.3.1 Type A: for product-to-product change over
5.3.1.1 Update the status board as “UNDER CLEANING” and switch “OFF” the main supply and release the pressure.
5.3.1.2 Detach the dust extraction & Deduster machine accessories attached to the machine.
5.3.1.3 Collect powder if any from hoppers, discharge chute and force feeder and transfer

it to the dedicated container Labeled as “non-Recoverable.
5.3.1.4 Remove hopper, feeder, discharge chute and other accessories.
5.3.1.5 Clean the surplus powder on the turret and powder settled on other parts of machine by vacuum cleaner.
5.3.1.6 Transfer above dismantled parts to wash room in virgin poly bag with duly filled “To Be Clean” Status Label.
5.3.1.7 Collect powder from top of machine, compression rollers, lower cam track, upper

cam plate area, die hole and turret with help of vacuum cleaner.
5.3.1.8 Remove front flight control plate and removes upper punch manually one by one

by rotating the hand wheel and collects them in die-punch trolley.
5.3.1.9 Unscrew anti-turning device to detach bend strip and plastic plug. Carefully remove lower

punches one after another manually by rotating the machine manually. Collect the lower

punches in die-punch trolley and arrange them similar to upper punches.
5.3.1.10 Remove Die-Locking Screw.
5.3.1.11 Remove all Dies one by one and collect it in die-punch trolley.
5.3.1.12 Clean and Store the Dies and Punches.
5.3.1.13 In Stainless Steel Container takes Isopropyl Alcohol and dips all die locking screws,

anti-turning plugs, anti-turning plates & screws clean them and then wipe them with dry lint free duster.
5.3.1.14 Clean the surface of machine with lint free duster soaked in Isopropyl Alcohol.
5.3.1.15 Wipe turret, die hole and bore of punch with lint free duster soaked in Isopropyl alcohol followed by dry lint free duster.
5.3.1.16 Thoroughly clean all dismantle parts by using Raw water and then wash with Purified water.
5.3.1.17 Clean mechanical panel internally and externally with the help of nylon brush and lint free cloth.
5.3.1.18 Record the activity in Equipment Log book.
5.3.2 Type B: for batch to batch change over (same product)
5.3.2.1 Switch “OFF” the electric supply to the compression machine.
5.3.2.2 Collect powder if any from Turret, Hoppers, Discharge Chute, and Feeder by vacuum cleaner or lint.
5.3.2.3 Wipe out total body of machine with dry clean lint free cloth.
5.4 Training shall be provided to the concerned person.

6.0 References:
In-house

7.0 Attachment
Nil

8.0 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.

9.0 Abbreviations:
SOP : Standard Operating Procedure
Pvt. : Private
Ltd. : Limited
QA. : Quality Assurance
QC : Quality Control
BMR : Batch Manufacturing Record
RPM : Round per minute
HDPE : High density Polyethylene

10.0 Revision History