URS OF COMPRESSION MACHINE 37 STATION DOUBLE ROTARY
|S. No.||Table of Contents|
|6||Inspection and Testing|
|7||Commissioning and Documentation|
|S. No.||Parameters||Required Specifications|
To be embossed / imprinted conspicuously on the equipment
|1.2||Description||37-station double rotary compression machine, D tooling PLC controlled compaction force measurement and it’s monitoring.|
|1.3||Use||The equipment will be used for compression of different product tablets (max. dimension 25 mm), Monolayer and bi layer tablets.|
|To be installed in Compression Area of Production Block
(i) Room Temperature 300C and RH less than 60%
(ii) Non flame proof area
|1.5||Glossary||As per Annexure-1|
|2.2||Material of Construction||All the contact part should be of SS 316 and non-contact parts preferrably of SS 304.|
|2.3||Electrical Construction||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:
i. Recipe management
ii.Initial ON/OFF starter with emergency stop of inching facility
iii.Hour meter for the accumulated running hours.
iv.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:
·Time duration for each stage.
· Alarms and Warnings
· System status ( Ready, Running etc.)
|Interface with other equipments 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
|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.).|
|3.2.5||Data collection||The following shall be recorded:
·Recipe based data
|3.3||Component Reference details||Mentioned here with make|
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.
Ø Batch data report.
Ø Recipe report
Ø Force data report
Ø Alarm history report.
Ø On time alarm
|3.4.4||Alarm System||Preferably the sound alarms / beep shall be provided alongwith light indication.|
|3.4.5||Power failure / recovery||In the event of a power failure, the system shall protect product against damage.
Depending upon the options chose in the overview section, the system will:
i. Manually restart based on operator inputs (operator initiates power recovery sequence)
|3.4.6||Emergency stop||The emergency stop mechanism(s) shall be provided.|
|To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.|
|5.||Maintenance||Supplier should provide (at minimum) the following maintenance instructions,
i. Maintenance and operation manuals alongwith as built drawings
ii. Lubrication instructions
iii. Daily checks on machine
iv. Cleaning procedures
|6.||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 from 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 to 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 to demonstrate the Performance of the machine at site as per agreed terms.
·The Supplier 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 manufacturers end for Motors / Gear Box / Fan and other critical bought out items with Serial nos.
|7.1||Development||The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.|
Start up support
Supplier to train the respective technical associates of pharma company on operation, maintenance and cleaning of the equipment wherever applicable
|8.2||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 user of any improvements
|9.||Packaging||Supplier to specify packaging of machine for safe transportation and delivery at the site|
|10.||Deviations||Any deviation from URS shall be highlighted.|
|11.||Delivery|| As per purchase order. To be delivered at
|URS||User requirement specifications|
|OFC||Over Fill Capacity|
|MCB||Miniature Circuit Beaker|
|PLC||Programmable Logic Control|
|CFM||Cubic Feet per minute|
|NPL||National Physical Laboratory|
|NIST||National Institute of Standards & Technology|
|P & ID||Process and Instrumentation Diagrams|
|SFU||Switch Fuse Unit|
|SPP||Single Phase Preventor|
|MPCB||Motor Protection Circuit Breaker|
|RTD||Resistance Temperature Detector|
|TEFC||Totally Enclosed Fan Cooled|
|SCADA||Supervisory Control and Data Acquisition|
|AISI||American Iron and Steel Institute|
|L & T||Larson & Toubro|
|BCH||Bhartia Cuttler Hammer|
|MOC||Material of Construction|
|MMI||Man Machine Interface|
|RCC||Reinforced Cement Concrete|
|RMG||Rapid Mixer Granulator|
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube