COMPRESSION MACHINE (MULTIPUNCHING MACHINE)

Page : 02-06

Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009

Prepared by: Asstt. Production Chemist

Checked By: Production Manager

Approved By

Q.A. Manager Director Sign.……….… Sign.………. Sign.………...…... Sign.…….……….

5.1.11 Get the approval from In-Process Quality Assurance Manager to start the operation.

5.1.12 Ensure that balance to be used for weighing is calibrated, by checking the balance calibration record.

5.1.13 Ensure the batch identity, status and weight of the bulk, which is to be compressed as per the “INPROCESS STAGE” label affixed on the Intermediate Product Container.

5.1.14 Check the signature of Inprocess Quality Assurance Manager in the approved by column of “INPROCESS STAGE” label of Intermediate Product Container.

5.1.15 Load the bulk to be compressed in the hopper of machine.

5.1.16 Bring the polythene lined high-density polyethylene container in the compression room for the storage of tablets.

5.2 OPERATION:

5.2.1 Switch “ON” the main electric supply of the machine. 5.2.2 Set the desired hydraulic pressure of machine.

5.2.3 Take a polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.

SARTHAK BIOTECH Pvt. Ltd.

STANDARD OPERATING PROCEDURE

5.2.4 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.

5.2.5 Place the duly labeled polythene bag lined high-density polyethylene container below the discharge chute of compression machine, for collection of the compressed tablets.

5.2.6 Operate the machine in “INCH” mode to check the smooth running of machine.

5.2.7 Start the feeder switch to fill the powder in the feeder. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET

COMPRESSION MACHINE (MULTIPUNCHING MACHINE)

Page : 03-06

Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009

Prepared by: Asstt. Production Chemist

Checked By: Production Manager

Approved By

Q.A. Manager Director Sign.……….… Sign.………. Sign.………...…... Sign.…….……….

5.2.8 Switch “ON” the machine by pressing green push button. 5.2.9 Run the machine for two minute.

5.2.10 Check the tablets for weight variation, thickness, hardness, friability, disintegration time and other parameters as specified in Batch Manufacturing Record.

5.2.11 Adjust the parameters to the desired specifications as specified in Batch Manufacturing Record.

5.2.12 After achieving desired parameters, stop the machine.

5.2.13 Inform In-process quality assurance officer to collect the sample for dissolution test, if required or as specified in Batch Manufacturing Record. 5.2.14 Remove the high-density polyethylene container in which the tablets are

collected and keep it aside on the container trolley.

5.2.15 Replace the “CONTAINER STATUS” label of high-density polyethylene container with “RECOVERABLES” label.

5.2.16 Tear off the “CONTAINER STATUS” label after confirming the details on it and put it in the waste bin.

5.2.17 Place the “Tablet De-duster” exactly below the discharge chute of compression machine.

SARTHAK BIOTECH Pvt. Ltd.

STANDARD OPERATING PROCEDURE

5.2.18 Take a fresh polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.

5.2.19 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.

5.2.20 After getting approval from Quality Assurance Manager, start the operation.

5.2.21 Record the operation start time in equipment usage and cleaning log and in Batch Manufacturing Record.

TITLE: SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE (MULTIPUNCHING MACHINE)

Page : 04-06

Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009

Prepared by: Asstt. Production Chemist

Checked By: Production Manager

Approved By

Q.A. Manager Director Sign.……….… Sign.………. Sign.………...…... Sign.…….……….

5.2.22 Inform the In Process Quality Assurance Officer to check the parameters. 5.2.23 Check the compressed tablets for In-process test parameters at regular

intervals as specified in Batch Manufacturing Record and record the details in In process Control Chart.

5.2.24 After the high-density polyethylene container is filled, replace it with another polythene lined high-density polyethylene container.

5.2.25 Take the gross weight of filled container and record the details on “CONTAINER STATUS” label, tie the polythene bag with tie band and keep the container on container trolley.

5.3 SHUT DOWN:

5.3.1 After completion of operation switch “OFF” the machine by pushing the red button.

5.3.2 Release the pressure in hydraulic system.

5.3.3 Switch “OFF” the main electric supply of machine.

5.3.4 Transfer the filled tablet containers and recoverables container to the respective place.

5.3.5 In case of day end compression (compression operation of batch not completed), transfer the bulk, remaining for compression, to the Intermediate Product Container and transfer to respective place.

SARTHAK BIOTECH Pvt. Ltd.

STANDARD OPERATING PROCEDURE

5.3.6 Remove the status label from the equipment, tear it off, and put in the dustbin.

5.3.7 Affix duly filled “TO BE CLEANED” label on the equipment.

TITLE: SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE (MULTIPUNCHING MACHINE)

Page : 05-06

Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009

Prepared by:

Asstt. Production Chemist Production ManagerChecked By: Q.A. ManagerApproved ByDirector Sign.……….… Sign.………. Sign.………...…... Sign.…….……….

5.4 CLEANING:

5.4.1 AT THE TIME OF DAY END AND BATCH CHANGE OVER: 5.4.1.1 Remove the “TO BE CLEANED” Label from the

equipment. Tear the label after checking the details on it. 5.4.1.2 Record the cleaning start time in the equipment usage and

cleaning log.

5.4.1.3 Clean the punches and dies by vacuum cleaner. 5.4.1.4 Clean the machine by dry lint free cloth.

5.4.1.5 Clean thoroughly, compression machine after every three batches as mentioned in 5.4.2.

5.4.2 AT THE TIME OF PRODUCT CHANGE OVER:

5.4.2.1 Remove the dies, punches from machine, and dipped in 70% v/v Isopropyl Alcohol for cleaning.

5.4.2.2 Dry the dies and punches with lint free cloth.

5.4.2.3 Lubricate the dies and punches with food grade oil and transfer to the respective place.

5.4.2.4 Remove the change parts of the machine and send to the equipment washing area.

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STANDARD OPERATING PROCEDURE

5.4.2.5 Clean the parts with raw water and ensure that the parts are visually clean.

5.4.2.6 Clean the parts with 0.1 % w/v of Teepol solution & flush with plenty of raw water to remove traces of Teepol solution.

5.4.2.7 Finally clean the parts with purified water.

TITLE: SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE (MULTIPUNCHING MACHINE)

Page : 06-06

Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009

Prepared by: Asstt. Production Chemist

Checked By: Production Manager

Approved By

Q.A. Manager Director Sign.……….… Sign.………. Sign.………...…... Sign.…….……….

5.4.2.8 Clean the machine body using lint free cloth dipped in potable water followed by dry lint free cloth.

5.4.2.9 Send the rinse water-sampling request to the Quality Assurance department to collect the rinse water sample for analysis of traces as per respective standard operating procedure.

5.4.2.10 Dry the parts using dryer.

5.4.2.11 Record the cleaning details in equipment usage and cleaning log and in area cleaning log.

SARTHAK BIOTECH Pvt. Ltd.

STANDARD OPERATING PROCEDURE

TITLE: SOP FOR OPERATION OF TUBE FILLING, SEALING,