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SOP on Operating Procedure for 35-Station Double Rotary Compression Machine

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A compression Machine is used in pharmaceuticals to compress granules to form a desired shape unit dosage form. So while operating this the proper procedure is to be followed to get high-quality products as per good manufacturing practice.

Double Rotary Compression Machine

1.0 Objective: To establish a procedure for the operation of the 35-station double rotary compression machine.

2.0 Scope: This procedure applies to the operation of the 35-station double rotary compression machine within the production department.

3.0 Responsibility: Officers and Executives in the Production Department are responsible for this procedure.
The Production Department Manager is responsible for overall compliance with this SOP.

4.0 Definitions: NA

5.0 Procedure:
5.1 Machine Preparation:

  • Ensure the equipment and area are clean and affix an ‘UNDER PROCESS’ label on the machine.
  • Record observations in the equipment usage log sheet.

5.2 Punch Set Collection:

  • Obtain the punch set based on specifications from the compression spire room.
  • Record the issuance in the Die Punches Utilization Record as per SOP No. PRD/042.

5.3 Cleaning of Die Punches:

  • Clean the die punch set with a mixture of 70% IPA and 30% water (70 ml IPA + 30 ml water) before installing them on the compression machine.

5.4 Setting Round Die Punches:

  • Fix the dies in die cavities using a Tommy.
  • Ensure the die is at the same level as the turret.
  • Place the lower punch in lower punch bores resting on the cam, and tighten the anti-turning Teflon plugs.
  • Place the upper punch in the upper punch bores.
  • Turn the flywheel and set all die punches using steps 1 to 4.
  • Ensure the punch moves freely within the punch bore and die while fixing upper and lower punches.

5.5 Setting Non-Round Die Punches:

  • Fix the die in the die cavity.
  • Place the upper punch in the upper punch bore and gently tap to position the die in the cavity.
  • Confirm the upper punch moves freely in the respective die.
  • Remove the upper punch, fix the dies using a Tommy, and ensure they’re at the same level as the turret.
  • Tighten the die-locking screws and cover them with the provided SS cover.
  • Confirm the upper punch moves freely in the respective die.
  • Place the upper punch on the cam track, then turn the flywheel and set all dies and punches similarly.
  • Remove the upper punch near the take-off piece slot, fix the take-off piece, and place the upper punch back in the upper punch bore. Tighten the punch locking screw.
  • Place lower punches in lower punch bores.
  • Fix the anti-turning Teflon plugs by tightening the spring plates.

5.6 Setting Feed Frame and Hopper:

  • Mount the recircular band on the turret.
  • Mount the feed frame on the feeder support platform, securing it with nuts and locking knobs.
  • Attach the hopper by screwing the bolt at the top.

5.7 Setting Cam and Doser:

  • Initially, keep the cam loose and fix it after setting two or three die punches.
  • Ensure the cam doesn’t touch any part of the machine, then fix the doser.

5.8 Operation:

  • Place a vertical deduster next to the compression machine’s outlet chute and a metal detector next to the deduster’s outlet chute.
  • Set up an SS container lined with a double polybag next to the metal detector’s outlet chute.
  • Load granules into the RHS and LHS hoppers, covering both.
  • Turn on the main switch.
  • Insert the key into the reset lock and turn it to the reset position. The screen will show zero product count.
  • Turn the flywheel to check for any loose parts.
  • Press the ‘START’ button on the control panel. Engage the machine by turning the engage/disengage lever to the engaged position.
  • To run the machine in inch mode, press the start and stop buttons alternately.
  • Check the weight, thickness, and hardness of individual tablets.
  • Ensure the tablet weight, thickness, and hardness are within specified limits in the respective BMR. If not,
  • Adjust weight by turning the weight adjustment lever clockwise to increase and counterclockwise to decrease.
  • Adjust thickness by turning the tablet thickness lever clockwise to increase and counterclockwise to decrease.
  • After setting weight and thickness, check the friability and DT of tablets as per the BMR for both LHS and RHS stations.
  • Record all observations in the respective BMR.
  • Reject tablets compressed during machine setting.
  • Operate the metal detector and vertical deduster as per SOP on “Operation of metal detector and Certicle deduster”.
  • To change the turret RPM, turn the rotary RPM knob clockwise to increase and counterclockwise to decrease.
  • Press the ‘STOP’ button to halt the machine.

5.9 After Operation:

  • Affix a ‘TO BE CLEANED’ label on the machine. Record all observations in the equipment usage log sheet.

6.0 Abbreviations:
SOP: Standard Operating Procedure
IPA: Isopropyl Alcohol
ml: Milliliter
BMR: Batch Manufacturing Record
RPM: Rotations per Minute
DT: Disintegration Test
SS: Stainless Steel
RHS: Right Hand Side
LHS: Left Hand Side

7.0 References:
SOP: Making entries in equipment usage and cleaning log sheet.
SOP: Issuance, use, and retrieval of punches and dies.
SOP: Operation of metal detector and vertical deduster.

8.0 Annexures:
None available.

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