Objective of URS for Compression Machine:
The URS is provided to define the important components, variables and options necessary for the Supplier to provide a functional of compression machine that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for D Tooling compression machine including the design, Performance and manufacture of the equipment.
The compression machine will be interfaced to the output and will be located in a designated operating area should be compatible with) occupational Exposure Limits (OELS) and a cGMP operation.
Table of Content
| Sr. No. | Description |
| Title page | |
| Table of contents of URS for Compression Machine | |
| Approval of Documents | |
| Objective of URS for Compression Machine | |
| Scope | |
| Location of equipment | |
| System/equipment/instruments details | |
| Scope of supply | |
| Brief system description | |
| Technical specification | |
| Safety features/Alarms | |
| List of Abbreviations |
Approval of URS for Compression Machine Documents:
Prepared by:-
| Name | Designation/Department | Signature | Date |
| Executive/Quality Assurance |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
| Manager/Production | |||
| Manager/Engineering |
Approved by:-
| Name | Designation/Department | Signature | Date |
| Manager/Quality Assurance |
Scope:
The scope of this document is to define the requirements of the D Tooling compression machine.
Location of equipment:
The Supplier shall deliver the equipment to facilty.
Machine will be installed in the Compression area with Class D background.
System/equipment/Instruments details:
| Name of the equipment | Compression machine |
| Tooling | D |
| Technology | High speed double side rotary tablet compression |
| Tablet Size | 5 mm to 30 mm |
Scope of Supply:
| Type of Device | Tablet Compression machine |
| Machine Standard | The current state of the art GMP Compliance. European medicine agency (EMA) and WHO, USFDA Regulations compliance. |
| Machine design standard for safety | The European machinery Directive 2006/42/EC.The European low voltage Directive 2014/35/EU |
| Room Condition | Room Temperature: – 25OC Relative humidity: – NMT 65%Zoning: Class D GradePressure: NLT 15 Pa |
| Features | Design conforming to cGMP standardsContact part SS 316 and noncontact parts SS 304.Simple and Convenient operation, Changeover, Cleanliness, Operator protection and Ease to maintenance.All controls like tablet thickness and weight adjustment are outside the compression zone.Turret Drive from closed gearbox through internal helical gearing with continuous lubrication.Force feeder for power feeding with bottom side drive.Clutch drive for safety, Ease and maintains free operation.Fast changeover and easy cleaning designed with easy removal weight adjustment sector.Upper guard with hydraulic cylinder and lower guard from SS 304 fitted limit switch.Turret made from magnetic graded casting.Compression pressure to be balanced by fixed pressure with disc type compression spring.Automatic Weight Controlling system.Auto lubrication system of two typesContinuously for turret internal gearing & bearing. Intermittent for fulcrum pin.Dust suction nozzle for controlling dusting.Closed dust free front electric control panel easy removal type.AC Frequency drive for turret motor and feeder motor. |
| Document & Certificate | Manuals and Maintenance Instructions Operator manualInstallation and assembly instructions for all devices.User’s manuals for all components.Trouble shooting guide.Maintenance Manual.Safety instruction.Training documentation. Electrical and Control diagrams Single line drawing for electrical distribution.Circuit diagramsEquipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports.IQ protocol and reportOQ Protocol and reportVendor should organize for Execution of IQ/OQ and support for PQ |
Brief system description:
Tablet compression machine is designed in an effort to exceed the highest cGMP requirement and to ensure the most economical and efficient tablet production.
The basic construction of the machine consists of :
- Base frame with stainless steel covering drive zone.
- Tablet Compression zone.
- Electric Controls Zone.
The Drive:
The machine is equipped with frequency controlled drive. A large torque can be achieved even at low speed and because of its high regulating speed. The turret is centrally driven by an electric motor with electromagnetic clutch, through rigid reduction gear box. The electromagnetic clutch is installed to protect the electric motor and machine.
The Feeder Systems:
The Tablet press has wide variety of applications that the large number of materials to be pressed in tablet shape has different characteristics. Different types of feeder systems ranging from a simple gravity feeder to complex forced including the possibility of constant level feeders. The feeder motor is installed in separate machine drive zone with variable frequency controlled to ensure high exception of tablet weight consistency through feeding performance of powder in high speed of the machine. The design of the feeder has been easy to remove and repositioning with out any tools. It is fitted with butterfly valve for flow controls of powder and powder discharge chute to empty the feeder.
The Take off systems:
Moving parts before sintering when they are still fragile is a delicate task. Removing them from the press requires handling systems.
The Pressure Loading & Overload Releasing:
Compression pressure to be balanced by fixed pressure with disc type compression spring.There are not require to set balance pressure it will take up to maximum pressure 65 KN/6.5 tons.
Dust Extraction System:
In high speed tableting, dust extraction is essential. The dust suction nozzles are fitted at compression point with quick release design.
Technical Specification in URS of Compression Machine:
| Particulars | Specification |
| Tablet size | 5 mm to 25 mm |
| Machine type | High Speed Double rotary tablet press with two hopper and two side outlet |
| Type of Tooling | “D” tooling |
| Output | Maximum:2,70,000 tablet per hour Minimum:50,000 tablet per hour |
| Turret speed | 05 to 70 RPM by VFD |
| Pre Roller Force | 10KN |
| Main Roller Force | 100KN |
| Max. Tablet Diameter | Dia-25 mm “D” tooling |
| Max depth of fill | 25 mm depth of fill by lower cam track |
| Tablet Thickness | 2 mm to 25 mm |
| Upper Punch Penetration | 2 to 8 mm |
| Turret Drive | Turret die pot made from SG IronUpper & lower part of turret made from SG iron with ENPT coating.Internal drive turret with internal heliacal gear pair drive through reduction gear box with belt drive motor.Internal helical gear fit inner side of the turret.Eccentric centre for helical gear drive to take higher load.Turret mounted on central pillar with bearing.Closed reduction gear box with worm drive with oil merged mounting on bottom drive area.Electromagnetic clutch for engage and disengage drive.Motor to gear box drive with timing belt.Turret speed 5 to 70 RPM. |
| Feeder | Force feeder with variable speed drive with hopper and flow control valves.03 Nos. feeder assemblyCylindrical with bottom cone type hopper.Hopper capacity 15 to 20 liter.MOC SS 316 of Hopper.Feeder frame made from Gun Metal.2/3 nos. Paddle with counter.Paddle speed 10 to 60 RPM by VFD.Feeder drive with reduction gear motor to feeder unit with gear train.Feeder drive unit mount inside the technical area.Feeder drive shaft is connected with easy coupling shaft with feeder drive shaft.There should be powder re-circulation bend with scrapper on both side. There should be powder scrapper assembly with powder scrapper and spring. |
| Feeder Stand | Provide rigid feeder stand with height adjustable.Feeder assembly is mounting on feeder stand.Tablet take of plate assembly mount on feeder stand.There should be both side feeder stand. |
| Weight adjustment | There should be 2 nos dozer assembly for RH side & LH side weight setting.Dozer assembly is having removable bracket type to easily fit and remove lower punch & die on the machine.Through dozer and wedge assembly by manual from both side of the machine.Dozer assembly fitted with dozer, wedge, dozer housing, dozer shaft, locking gear & spring and bracket. |
| Main compression tablet thickness adjustment | To be set from outside of the machine and top of the machine manually.There are 2 nos assembly for RH side & LH side for setting tablet thickness. |
| Upper punch penetration for main compression station | To be set from outside of the machine and top of machine manually.There should be closed gear box link with universal joint with sprocket & chain driven shaft with seiko dial for accurate setting from outside.There are 2 nos assembly for RH side & LH side for setting for penetration of upper punch. During setting the upper rolls and lower roll assembly move up and down together by gear drive assembly to set upper punch penetration. So this function is not destruct tablet thickness. |
| Compression Pressure balance | Compression Pressure to be balanced by fixed pressure with disc type compression spring. |
| Discharge Chute | There should be 02 nos. discharge chute.Three path discharge chute of MOC SS 316 |
| Upper cam Guide | The Upper cam track has small degree for smooth moving.Upper cam track are fitted in the upper cam plate for easy fix and rigid and perfect position fixing of cam.There are upper lifting cam, High position cam and lowering cam.There provide two side cam inserter for fix and remove punches with key. |
| Lower cam & Ejection cam | The Lower cam and ejection cam are fitted on special stand for easy setting and remove.The lower cams have large degree for easy move of lower punch.Ejection cam track have large degree to easy eject tablet with less load.Lower cam track and ejection cam track are easily fit and remove from the main machine base from top side.Lower cam track and ejection cam track area cover with easily remover cover with knob. |
| Upper guard | Manual hinged of acrylic.Upper guard hinging in top roof cover assembly.All upper guard should be fit with interlock limit switch.Upper guards are fitted with gas cylinder for easy up and down. |
| Lower Guard | The technical area covers with lower guard.Enclosure of drive unit and made from SS 304.All lower guard fit with interlock limit switch. |
| Lubrication System | Automatic lubrication system provide with lubrication pump and manifold and piping to connect internal teeth ring & centre pillar.Lubrication system provide with timer to set lubrication ON- OFF time.Lubrication pump is drive with shaft for main reduction gear box so when machine is start it is automatic start.The return line with tank.The tank is having level sensor for minimum level. |
| Machine Mounting | It should be 04 nos Anti vibration pad with 100 mm/ 150 mm distance piece. |
| Electric panel | Electrical panel with push button and digital indicator.ON-OFF turret motor.Clutch engages & disengage.Inching function.Set turret speed increased and decreased.Turret speed set -actualFeeder motor ON- OFFFeeder speed set -ActualEmergency stop switch.Electric panel with MCB, contactor, overload relay, controls relay, VFD, SMPS. |
Safety Features/Alarms:
- Emergency stops switches for four side of the machine.
- Motors overload Alarm and machine will stop.
- AC VFD Overload Alarm and machine will stop.
- Servo motors Movement Notification Alarm.
- Servo Motors safety Alarm and machine will stop..
- Fill cam identification notification.
- Rejection control Alarm and machine will stop.
- High Rejection notification Alarm and machine will stop..
- Guards Interlock Alarm and machine will stop..
- Lubrication oil level identification.
- Low Powder level in hopper Alarm and machine will stop.
- Encoder position disturb Alarm and machine will stop.
- Individual compaction force high Alarm and machine will stop..
- Safety limit switch on doors of enclosures to avoid any accidents. Machine should not start if any of the door is open.
- All moving parts (compression area) should be enclosed with toughen glass.
Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| QA | Quality Assurance |
| cGMP | Current Good manufacturing |
| mm | Milli Meter |
| Ltr | Litre |
| Hr | Hour |
| MOC | Material of Construction |
| HMI | Human Machine Interface |
FAQ’s (Frequently Asked Questions) for URS of Compression Machine
Q-1 What is a User Requirement Specification for a Compression Machine?
Answer: A URS for a compression machine outlines the functional, technical, and regulatory requirements that the machine must meet to perform its intended purpose, typically in industries such as pharmaceuticals, food, or manufacturing.
Q-2 Why is a URS important for a Compression Machine?
Answer: A URS is crucial because it ensures that all stakeholders (e.g., engineers, manufacturers, quality assurance teams) are aligned on the machine’s requirements. It serves as a guide for procurement, installation, and performance validation, ensuring the machine meets operational, safety, and regulatory standards.
Q-3 What should be included in the URS?
Answer: The URS should cover:
Technical Specifications: Machine capacity, power requirements, material compatibility, etc.
Functional Requirements: Automation level, speed, precision, etc.
Safety Requirements: Noise, vibration limits, safety features, etc.
Q-4 What are the key technical requirements to define in the URS?
Answer: Key technical aspects include:
Compression Force: Required range and tolerance.
Output Capacity: Production rate (e.g., tablets per hour).
Tooling: Dies, punches, and their interchangeability.
Automation and Control: PLC/automation system specifications, HMI interface, and monitoring features.
Q-5 What safety features should be included in the URS?
Answer: Key safety features to include:
Emergency stop buttons.
Interlocks to prevent operation during maintenance.
Guarding around moving parts to prevent accidents.
Overload protection for motors and mechanical components.
Operator safety training requirements