COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION)
Tablet Compression Machine or rotary tablet compression machine is designed to compress tablets from granulated powders. Machine equipped with cGMP compliance for making tablets in pharmaceutical, herbal, food, confectionary, and chemical to name a few. The machine is also called a GMP model tablet compression machine. Tablet compression machines consist of single rotary tablet compression machines as well double rotary tablet compression machines.
A machine having heavy-duty construction with a turret made from casting materials. Dies and punches are made from high-quality materials to avoid rusting and contamination. Controls are provided outside of the door for easy operation and the operator’s convenience.
Working and Principles of tablet compression machine
Tablet Compression Machine uses granulated powder to produce medicines (tablets and pills). There are punches and a die that together form a cavity. The powder is entered into this cavity and when punches are pressed with a particular force, the material gets fused. The rotary tablet press machine consists of multiple stations and they rotate to compress the powder and form tablets.
The tablet compression machine basically works on hydraulic pressure. This pressure performs a key role in any type of Tablet Machine. It is transmitted unreduced through the static fluid. Any externally applied pressure is transmitted through the static fluid to all directions in the same proposition. which results make it suitable to increase pressure.
To form a tablet, the granulated powder material must be metered into a cavity formed by two punches and a die, and then the punches must be pressed together with great force to fuse the material together. There are two types of tablet presses called Single Station Tablet Press and Multi Station Tablet Press. The working of these machines differs in terms of production output and feature requirements.
Key Features of tablet compression machine
- cGMP Model.
- Pre Compression and Main Compression Force.
- The turret is driven by a centrally fitted oil-emerged gearbox.
- Maximum Speed of Turret.
- Tooling combination of D, B & BB.
- Pressure adjustment controls from outside area.
- Pressure loading and overloading pressure release mechanism through Hydro-Pneumatic Power Pack System.
- Main motor and force feeder motor driven through VFD.
- Auto lubrication arrangements hence less maintenance.
- Upper Punch Penetration.
- Anti-Vibration Mounts.
- Electronic Digital Tablet Counter cum RPM indicator.
- Interlock Switches to all upper guards.
- Pneumatic powder loading system.
- PLC system with Graphical User Interface
USER REQUIREMENT SPECIFICATION (URS)
The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification or User Acceptance Testing. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.
The URS is generally a planning document, created when a business is planning on acquiring a system and is trying to determine specific needs. When a system has already been created or acquired, or for less complex systems, the user requirement specification can be combined with the functional requirements document.
Table of Contents of compression machine URS
- Salient Features
- Operational Requirements
- Inspection and Testing
- Commissioning and Documentation
TECHNICAL REQUIREMENT OF COMPRESSION MACHINE URS
Equipment No. : To be embossed/imprinted conspicuously on the equipment
Description: 37-station double rotary compression machine, D tooling PLC controlled compaction force measurement, and its monitoring.
The equipment will be used for compression of different product tablets (max. dimension 25 mm), Monolayer and bi-layer tablets.
To be installed in the Compression Area of the Production Block
- Room Temperature 300C and RH less than 60%
- Non-flame-proof area
Material of Construction:
All the contact parts should be of SS 316 and non-contact parts preferably of SS 304.
Non-flameproof, the panels, and other parts shall be of SS 304.
- Output 200000 tablets per hour for Monolayer
- Output 44000 tablets per hour for Bilayer
- PLC based with minimum following features:
- Recipe management
- Initial ON/OFF starter with the emergency stop of the inching facility
- Hour meter for the accumulated running hours.
- Initial machine start-up and stop rejection device.
Data & Security:
- Data controls should address the following issues (preferably)
- Operator interface access levels
- Frequency of data point collection
- Hardcopy/electronic data collection requirements
- Data retention time on the system
- Data storage media
- Language requirement: Information shall be in ‘English’
- ·Access to all Input/output values and system status bits shall be provided through a data-communication link. Security for data and operator access is provided by User ID/Password.
User interface with supervisors and operators for the control platform:
This panel shall provide the necessary switches, indicators, and devices to operate. The following shall be displayed:
- Air pressure.
- Time duration for each stage.
- Alarms and Warnings
- System status ( Ready, Running, etc.)
Interface with other equipment and systems:
The port shall be capable of being configured to communicate the following data to a supervisory control and data acquisition (SCADA) node. Available shall be:
- All process variables
- Alarms and Warnings
- ·System status
List the total number of different access levels that will be required (minimum three levels). Provide a general description of the access rights for each level (screen navigation, operational control, control loop variable manipulation, alarm set point manipulation, etc.).
The following shall be recorded:
- Time duration
- Recipe based data
- Air pressure
The system shall operate with a minimum of operator involvement. Operation shall be safe form an operator and environmental standpoint.
The system shall be operated locally at the equipment itself.
- Manual and automatic
- Type D tooling.
- Max. tablet diameter 25 mm
- Max. depth of fill 20 mm
- Main compaction force data.
- Auto weight control.
- Auto tablet rejection.
- Tablet sampling device.
- Tight punch monitoring device (Upper Punch)
- Powder level alarm message.
- Menu screens to convenient machine setup.
- Batch documentation/printing option
- Ø Batch data report.
- Ø Recipe report
- Ø Force data report
- Ø Alarm history report.
- Ø On-time alarm
- Computer-integrated and/or PLC control with touchscreen operation
- First-aid spare parts shall be supplied along with the machine.
- Lower punch scrapper seals are to be fitted.
- Overload pressure release is to be incorporated as a safety feature, it should be adjusted to relieve the pressure with minimum effort.
- variable speed drive.
- Maximum operating pressure for compression station to be 10 tons.
- A gravity feed frame is also to be incorporated in addition to the forcing feeding device.
- Initial machine start-up and stop tablet rejection device.
Preferably the sound alarms/beep shall be provided along with light indication.
Power failure / Recovery:
In the event of a power failure, the system shall protect the product against damage.
Depending upon the options chosen in the overview section, the system will:
- Manually restart based on operator inputs (operator initiates power recovery sequence)
The emergency stop mechanism(s) shall be provided.
To provide utilities at ONE POINT is the user’s responsibility. Supplier to give details and drawings for the exact size, location, type, capacity, etc. of the utilities required.
The supplier should provide (at minimum) the following maintenance instructions,
- Maintenance and operation manuals along with as-built drawings
- Lubrication instructions
iii. Daily checks on the machine
- Cleaning procedures
Inspection and Testing:
Equipment shall be inspected and tested by the user at the supplier’s factory w.r.t DQ prepared by Supplier and approved by the pharma company before execution.
In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures. The Supplier shall notify the User two weeks in advance of the start of this test.
The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution. A minimum of two weeks shall be allowed for the User to review and comment and/or approve the Factory Acceptance Test Specification.
Commissioning and Documentation:
- IQ/OQ/PQ to be completed by the supplier along with M/s Company representatives.
- The Supplier is to demonstrate the Performance of the machine at the site as per agreed terms.
- The Supplier is to submit the following certificates:
- Exact use in the equipment designed
- Calibration certificates of all the instruments used having traceability to NPL / NIST
- Performance certificates of Tests conducted
- At the manufacturer’s end for Motors / Gear Box / Fan and other critical bought-out items with Serial nos.
The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Supplier to train the respective technical associates of the pharma company on operation, maintenance, and cleaning of the equipment wherever applicable
Telephone / Fax / E-mail ID / Address
Replacement parts availability list (normal lead times shall be listed)
System improvements (supplier shall notify the user of any improvements
Supplier to specify packaging of machine for safe transportation and delivery at the site
Any deviation from URS shall be highlighted.
As per the purchase order. To be delivered to Company Address
URS:User requirement specifications
DQ : Design Qualification
IQ :Installation Qualification
OQ : Operational Qualification
PQ: Performance Qualification
0C : Degree Celsius
OFC:Over Fill Capacity
MCB : Miniature Circuit Beaker
PLC : Programmable Logic Control
CFM : Cubic Feet per minute
RH : Relative Humidity
Pa : Pascals
NPL : National Physical Laboratory
NIST:National Institute of Standards & Technology
P & ID : Process and Instrumentation Diagrams
MS : Microsoft
O/L : OverLoad
SFU:Switch Fuse Unit
SPP : Single Phase Preventor
MPCB:Motor Protection Circuit Breaker
RTD : Resistance Temperature Detector
KWH : Kilowatt-hour
TEFC : Totally Enclosed Fan Cooled
SCADA:Supervisory Control and Data Acquisition
AISI : American Iron and Steel Institute
CI : Cast Iron
L & T :Larson & Toubro
BCH : Bhartia Cuttler Hammer
MOC: Material of Construction
SS : Stainless Steel
MS : Mild Steel
MMI: Man-Machine Interface
RCC: Reinforced Cement Concrete
RMG :Rapid Mixer Granulator