Compression Machine
The major components of the equipment are identified as:-
- Powder Feeding unit.
- Powder transfer unit
- Compression unit
- Hydraulic power pack assembly
- Discharge unit
The Compression machine 26 station D tooling, a single rotary high-speed tablet press, is a machine incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor, and rejection/sampling port.
The powder feeding unit has an S.S. 316 Hopper of capacity 20 Liter that rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which controls the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhances the powder flow. A barrel–type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.
The powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter-rotating paddles of S.S. 316, driven by a reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high–speed tablet press. The function of the tail-over die is to keep the filled die covered until the last moment before the upper punch enters the die.
The drive unit has a main motor of 5HP that drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft.
The turret is a three-piece structure having the center die tablet of S.S. 316 and upper and lower pieces of cast iron of SG 400/15. The upper piece holds the upper punches, which rest on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.
The compression unit comprises an upper main pressure roll assembly having a roll center, pressure roll, and pressure roll pin. The roll center holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible for deciding the tablet thickness.
Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight-adjusting head through a dozer-adjusting screw with the help of a dial.
The hydraulic power pack assembly system controls the safety overload mechanism, which governs the maximum pressure, and level, at which particular tablets are being made. The oil reservoir for this system is located in the front LH corner of the lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.
The tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die to avoid tablet-chipping problems. As soon as the tablet is ejected it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. The tablet discharge chute is made S.S. 316 with an acrylic cover. Tablets slide out through this chute to the container.
Auto lubrication system is provided for the lubrication of all critical pinpoints like roll pins, it comprises of a lubrication tank, a motorized pump, a distribution manifold, and pipelines. This pump operates on a timer set in the PLC. It should be noted that the ON time should be less than the OFF time, to prevent oil flooding. The dozing of oil’s respective critical points can be throttled through the distribution manifold.
A lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition, the tablet gets a clean, smooth surface on the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. To avoid lubricant, the scraper mechanism is built in. The stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray, the oil is transported downward through a funnel and a hose line and returned to the tank.
The working principle of compaction force control is whenever the powder is compressed from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the transducer and the PLC. The data control screen displays the individual force of all 26 punches.
OQ (Operational Qualification)
TABLE OF CONTENTS
- Approval
- Objective
- Responsibility
- System Description
- Pre-requisite of Operational Qualification
- Operational Qualification Procedure -Training of concerned personnel, Critical Instrument Calibration, Key Functionality Test, Test Data Report Sheet, Safety key Features Test, SOP Verification
- Deviation Details(If Required)
- Change Control (If Required)
- Revalidation Criteria
- Acceptance Criteria
- Summary Report
- Conclusion
- Reference Documents
OBJECTIVE OF COMPRESSION MACHINE OQ: –
The purpose of the operational Qualification protocol is: –
To qualify the equipment for its operational attributes of equipment.
To ensure that the major critical instruments identified in the Installation Qualification protocol are calibrated.
To establish that the Equipment operates within its desired operating ranges.
To assure that the Equipment serves the intended purpose.
To establish the draft SOP prepared for the operation, cleaning, and preventive maintenance of Equipment.
RESPONSIBILITY: –
The validation team comprising a representative from each of the following concern departments shall be responsible for the overall compliance with this Qualification protocol:
Engineering Department
Production Department
Quality Assurance Department
The Production and Engineering shall be responsible for checking the operation and recording operational data as per the procedures outlined in this protocol.
The Manager of Engineering shall be responsible for verifying the data recorded in the Operational Qualification Protocol.
The Quality Assurance Department shall be responsible for the final review of the qualification documents and their compliance to meet the acceptance criteria of the Operational Qualification protocol.
PRE REQUISITE OF COMPRESSION MACHINE OQ (OPERATIONAL QUALIFICATION): –
Ensure the cleanliness of the area where equipment is to be installed.
Equipment should be installed properly as defined in the Installation Qualification protocol of the equipment.
All the utilities are connected properly and verified for operation.
All the Electrical connections are connected properly and verified for Operational.
The training has been imparted to all concerned personnel including the validation team team for conducting Operational Qualification.
COMPRESSION MACHINE OQ (OPERATIONAL QUALIFICATION) PROCEDURE: –
A draft SOP shall be prepared on the basis of supplier guide for operation, cleaning and preventive maintenance before the qualification testing.
Prior to the operational qualification test, the concern personnel shall be trained by the engineer from the supplier on the operational features of the equipment / system this training shall be recorded.
Calibrate the critical instruments located on the equipment (as identified during installation qualification) as per in house SOP of the instrument calibration or the manufacturer’s instruction. Record the date of calibration & due date.
The trained personnel shall carry out the Operational Qualification and record the observations of qualification test.
Operate the equipment as per the draft SOP’s, record the change if any and confirm the SOP’s.
Report the deviations if any observed.
TRAINING DETAILS: – The concerned personnel and validation team should be qualified for Operation of the equipment by supplier’s representative / qualified person.
Title: Operation, function and trouble shooting procedure of equipment.
Name of the Trainer:
PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION
INSTRUMENT CALIBRATION: –Calibrate the critical instrument as identified below before the operation of the equipment.
| Name of the Instrument | Location |
| Pressure Gauges. | Near incoming air |
| Pressure Gauges. | Near discharge chute. |
| Pressure Gauges. | For Tonnage |
KEY FUNCTIONALITY DURING COMPRESSION MACHINE OQ: –
Purpose:
The purpose of this procedure is to demonstrate that the control panel and other manual operations of the Tablet Compression Machine function as specified by the manufacturer.
Testing:
Check all the displays on the panel are identified.
Turn on the power from the electrical panel.
Set the control on the panel.
Verify functionality of each component on the control panel against its Specified functions.
Red switch for main electric supply ON / OFF
Mushroom head red emergency stop button
Observe and record the responses in the Testing Data Sheet
TESTING DATA SHEET FOR COMPRESSION MACHINE OQ: –
| Test Particulars | Specified Function |
| Turn the isolator knob to the “ON” position. | PLC should display a “welcome” screen. |
| Press the “Main Menu” touch button. | PLC should display the “Main Menu” Screen. |
| Press the “Operator Screen” touch button. | PLC should display “Operator Screen”. |
| Press the “Product Name” touch button. | PLC should display the numeric and alphabet touch buttons. |
| Enter the product name “CEFF 500” (up to eight characters) using alphabets and numeric touch buttons. | PLC should accept Product names of up to eight characters.
PLC should display “CEFF 500” against the Product Name. |
| Again press the “Product Name” touch button. | PLC should display the operator screen again. |
| Press the “Batch Size” touch button. | PLC should display numeric touch buttons. |
| Enter Batch size 200,000 (up to 6 characters) using numeric touch buttons. | PLC should accept Batch sizes up to 6 characters.
PLC should display 200,000 against Batch Size. |
| Press the “Batch Size” touch button again to go back to the operator screen. | PLC should display “Operator Screen”. |
| Press the “Batch Number” touch button. | PLC should display numeric and alphabetic touch buttons. |
| Enter “Batch Number” A 2001 (up to 8 characteristics) using alphabetic and numeric keys. | PLC should accept Batch Numbers up to 8 characters.
PLC should display 2001 against the Batch Number. |
| Again press the “Batch Number” touch button. | PLC should display “Operator Screen”. |
| Press the “Batch Reset” touch button. | PLC should display 000000 against the Tablet produced. |
| Decrease the pressure load using the pressure release knob manually up to 30 KN. | The digital force indicator provided on the right-hand side of the machine should display 30 KN. |
| Further, decrease the pressure load using the pressure release knob manually up to 20 KN. | The digital force indicator provided on the right-hand side of the machine should display 20 KN. |
| Press the “Manual Operation” touch button, on the ‘Main Menu’ Screen. | PLC should display the “Manual Operation” screen. |
| Press the engage touch button of the clutch control and then press the “jog” touch button of the Main motor.
Check the direction of rotation of the Turret. |
The main motor should start rotating.
The turret should rotate smoothly in an anti-clockwise direction |
| Leave the “jog” touch button on the Main motor. | The main motor and Turret should stop rotating. |
| Press the “Start” touch button on the main motor. | The main motor and Turret should start rotating. |
| Press the “Stop” touch button on the main motor. | The main motor and Turret should stop rotating. |
| Press the Jog touch button of the feeder motor.
Check the direction of rotation of the feeder. |
The feeder motor should start rotating.
The feeder should rotate smoothly in a clockwise direction. |
| Leave the “jog” touch button on the feeder motor. | The feeder motor and feeder should stop rotating. |
| Press the “Start” touch button on the feeder motor. | The feeder motor and feeder should start rotating. |
| Press the “Stop” touch button on the Feeder motor. | The feeder motor and feeder should stop rotating. |
| Press the “Manual” touch button to go to “Auto” mode. | PLC should display “Auto” in place of “Manual”. |
| Press the “Start” touch button on the main motor and feeder motor. | The main motor and feeder motor should not run in “Auto” mode. |
| Press the “Main” touch button. | PLC should display the “Main” menu screen. |
| Press the “Operator Screen” touch button. | PLC should display “Operator Screen”. |
| Check ‘Operator Screen’ for ‘Product Name’, ‘Batch Size’, ‘Batch Number’, and ‘Set Turret RPM’. | The PLC should display the Product Name Batch Size 200,000 Batch Number and Set Turret RPM 20. |
| Press the “Batch Start” touch button and Check for the sequence of operations. | The main motor should start rotating, followed by the Turret, feeder motor, and feeder. |
| Check for any abnormal sounds during the operation. | No abnormal sound should be heard. |
| Check the “Turret” RPM | The Turret should rotate at a RPM of 14 ± 10%. |
| Increase the Turret RPM by pressing the ‘+’ touch of the “Set Turret RPM”, to 30. | The Turret should rotate at a RPM of 30 ± 10% |
| Further increase the Turret RPM by pressing the ‘+’ touch of the “Set Turret RPM”, to 50. | The Turret should rotate at a RPM of 50 ± 10%. |
| Press the “Batch halt” touch button. | The machine should stop running. |
| Press the “Main” touch button. | PLC should display “Main Menu Screen”. |
| Switch off the main supply by turning the isolator knob to the ‘Off’ position. | PLC should be switched Off. |
SAFETY FEATURES TEST FOR COMPRESSION MACHINE OQ (If applicable)
| Safety Feature Description | Specified Function | Observations |
| Password locking. | The machine will not run in auto/manual mode without the correct password login in the required stage. | |
| Low compressed air. | Machine status will indicate low air pressure in red. | |
| Safety Guard | The machine will not run in auto mode while the gate is open. | |
| Reason entry | The machine will not re-start without entering the proper stopping reason. | |
| Batch counting | The machine will automatically stop after compression of one batch in Nos. | |
| Stop during continuous rejection. | The machine will stop while rejection will continue. |
SOP VERIFICATION DURING COMPRESSION MACHINE OQ:
Operating, Cleaning & Preventive Maintenance
DEVIATION DETAILS (If Applicable)
CHANGE CONTROL (If Applicable)
RE-VALIDATION CRITERIA :
Operation Qualification to be re-qualified on
Replacement of a major component of the equipment with a new component.
Any major modification in the existing equipment
Shifting of the equipment from one location to another
During monitoring if equipment is found to be malfunctioning
ACCEPTANCE CRITERIA FOR COMPRESSION MACHINE OQ:
Operational Qualification shall be considered acceptable when all the conditions specified in various have been met.
SUMMARY FOR COMPRESSION MACHINE OQ:
The acceptance criteria of the protocol and Specific checkpoints are checked and verified as per the abovementioned operational checklist and found that all the parameters met the specification.