COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION)
Table of Contents of compression machine URS
- General
- Salient Features
- Operational Requirements
- Utilities
- Maintenance
- Inspection and Testing
- Commissioning and Documentation
- Training
- Packaging
- Deviations
- Delivery
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.
Use:
The equipment will be used for compression of different product tablets (max. dimension 25 mm), Monolayer and bi-layer tablets.
Field Identification:
To be installed in the Compression Area of the Production Block
- Room Temperature 300C and RH less than 60%
- Non-flame-proof area
Salient Features
Material of Construction:
All the contact parts should be of SS 316 and non-contact parts preferably of SS 304.
Electrical Construction:
Non-flameproof, the panels, and other parts shall be of SS 304.
Operational requirements
Capacity:
- Output 200000 tablets per hour for Monolayer
- Output 44000 tablets per hour for Bilayer
Control:
Through PLC
- 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
Security level:
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.).
Data collection:
The following shall be recorded:
- Time duration
- Recipe based data
- Air pressure
Functional Requirements
Operation:
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
Process requirement:
- 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
- Security
Another requirement:
- 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.
Alarm System:
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)
Emergency stop:
The emergency stop mechanism(s) shall be provided.
Utilities:
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.
Maintenance:
The supplier should provide (at minimum) the following maintenance instructions,
- Maintenance and operation manuals along with as-built drawings
- Lubrication instructions
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.
PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION
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.
Development:
The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Training :
Start-up support:
Supplier to train the respective technical associates of the pharma company on operation, maintenance, and cleaning of the equipment wherever applicable
Post-start-up support:
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
Packaging:
Supplier to specify packaging of machine for safe transportation and delivery at the site
Deviations:
Any deviation from URS shall be highlighted.
Delivery:
As per the purchase order. To be delivered to Company Address
Annexure-1
GLOSSARY
URS:User requirement specifications
DQ : Design Qualification
IQ :Installation Qualification
OQ : Operational Qualification
PQ: Performance Qualification
dB: Decibels
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
