1.0 OBJECTIVE:
1.1 The objective of this SOP is to describe, in a clear and comprehensive manner, the step-by-step operation of the Compression Machine (SUMA PRESS MAX – 37D / 45DB) to ensure safe, consistent, and reproducible compression of tablets as per approved process parameters and manufacturer’s instruction manual.
2.0 SCOPE:
2.1 This SOP applies to all compression activities carried out on the SUMA PRESS MAX Double Rotary Tablet Press installed in the tablet compression area of the manufacturing facility.
3.0 RESPONSIBILITIES:
3.1 Production Operators:
3.1.1 Responsible for operating the Compression Machine strictly as per this SOP.
3.1.2 To report any abnormal observations immediately.
3.2 Designee Production:
3.2.1 Responsible for ensuring that operators are trained and that the procedure is followed during every batch.
3.3 Designee Quality Assurance (QA):
3.3.1 shall ensure line clearance.
3.3.2 To verify compliance.
3.3.3 To review batch-related documentation.
3.4 Engineering Dept:
3.4.1 shall ensure equipment readiness.
3.4.2 To attend breakdowns.
3.4.3 To maintain the equipment and PLC/HMI system.
4.0 DEFINATIONS:
4.1 Pre-compression: Initial compression applied to remove air from granules.
4.2 Main Compression: Final compression applied to achieve desired tablet hardness.
5.0 PROCEDURE:
5.1 Safety Precautions:
5.1.1 Ensure that all safety guards, polycarbonate covers, and interlocks are properly in place before starting the machine.
5.1.2 Ensure Emergency Stop switch shall be functional and released.
5.1.3 Safety guards shall not be opened while the machine is in operation.
5.1.4 Compression pressure shall not be adjusted when the machine is in OFF condition.
5.1.5 Lock-out / Tag-out procedure shall be followed during maintenance or troubleshooting.
5.2 Prestart Check and operation:
5.2.1 The area shall be free from previous product, documents, or materials.
5.2.2 Line clearance shall be performed by Machine Operator followed by Designee Production and then Designee QA.
5.2.3 Inspect the Compression Machine to ensure that cleaning has been performed and documented as per the cleaning SOP.
5.2.4 Confirm availability of required utilities.
5.2.5 Ensure correct punches and dies are available, clean, and approved for use.
5.2.6 Ensure lubrication system oil level is adequate and auto-lubrication pump is in ON condition.
5.3 Machine Start-Up:
5.3.1 Switch ON the main power supply of the Compression Machine and open the electric panel and ensure all MCBs are switched ON.
5.3.2 Jog / Inch the machine manually using flywheel to ensure free movement of turret.
5.3.3 Run the machine in jog / inch mode for few rotations without punches and dies to confirm correct direction of rotation.
5.4 Fitting of Dies and Punches:
5.4.1 Open the front-side cover and expose the punch loading position.
5.4.2 Clean die holes, punch guides, and turret thoroughly.
5.4.3 Fit dies into the die plate using die pressing rod ensuring they are flush with the turret surface.
5.4.4 Tighten die lock screws carefully without over tightening.
5.4.5 Insert lower punches and ensure free upward and downward movement.
5.4.6 Insert upper punches and ensure proper alignment.
5.4.7 After installation, rotate the turret manually to confirm smooth movement.
5.5 Installation of Hopper and Feed Frame:
5.5.1 Install the hopper on the SS hood and secure with SS knobs.
5.5.2 Install the feed frame assembly and interconnect circular blades properly.
5.5.3 Ensure feed frame does not touch the turret surface.
5.5.4 Connect dust nozzle, dust extractor pipe, and outlet channels properly.
5.6 Operation and Parameter Setting:
5.6.1 Set tablet weight (dose) using calibrated weight adjustment wheels.
5.6.2 Set tablet thickness (compression force) using calibrated pressure adjustment wheels.
5.6.3 Adjust powder flow using hopper gate valve and force feeder speed.
5.6.4 Synchronize turret speed and feeder speed to avoid powder spillage.
5.7 Compression Operation:
5.7.1 Start the machine at slow speed and gradually increase to required RPM.
5.7.2 Observe tablet appearance, weight, thickness, and hardness.
5.7.3 Make fine adjustments to weight and pressure as required during operation.
5.7.4 Monitor lubrication points and ensure oil dripping is visible.
5.7.5 Collect tablets through outlet channels and transfer to approved containers.
5.8 In-Process Checks:
5.8.1 Check tablet weight, thickness, hardness, and appearance at defined intervals as per BMR.
5.8.2 Record all observations in batch manufacturing records.
5.8.3 Immediately stop the machine in case of abnormal noise, vibration, or tablet defects.
5.9 Shutdown Procedure:
5.9.1 Stop powder feeding and allow machine to run empty.
5.9.2 Reduce turret speed to zero and stop the machine.
5.9.3 Switch OFF main power supply.
6.0 REFERENCE:
6.1 Instruction Manual – SUMA PRESS MAX Double Rotary Tablet Press.
6.2 Equipment Cleaning SOP.
6.3 Batch Manufacturing Record (BMR).
7.0 RECORDS:
Sr No. Title Document No.
NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01