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.
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.