Tamplate for User Requirement Specification
TECHNICAL Specifications
S. No. | Parameters | Required Specifications |
1.
1.1 1.2 1.3 1.4 1.5 |
General
Equipment No. Description Use Field Identification Glossary |
|
2.
2.1
2.2 2.3 2.4 |
Salient Features
General
Material of Construction Finish Electrical Construction |
Smooth Finish/matt finish/mirror finish Non flameproof / flameproof
|
3.
3.1 3.2 3.3 3.4 3.4.1 3.4.2
3.4.3
3.4.4 3.4.5 3.5 3.6 3.7
3.8
3.9 |
Operational requirements
Capacity Control Parameter Desired Accuracy Control Data & Security User interface with supervisors and operators for the control platform Interface with other equipments and system Security level Data collection Component Reference details Functional Requirements Alarm System
Power failure / recovery
Emergency stop |
Preferably the sound alarms / beep shall be provided along with light indication In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention to re-start. The emergency stop mechanism(s) shall be provided. |
4. | Utilities
|
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 the following maintenance instructions,
i.Operation and Maintenance manuals along with as built drawings ii. Lubrication instructions iii. Daily checks on machine Cleaning procedures |
6. | Inspection and Testing | |
7.
7.1 |
Commissioning and Documentation
Development |
· IQ/OQ/PQ to be completed by the supplier along with representatives.
· The Supplier to demonstrate the Performance of the machine at User site as per agreed terms. The Supplier shall provide a Project Manager for the project to provide a single communication point with the User. |
8.
8.1 8.2 |
Training
Start up support Post start up support |
Supplier to train the respective technical associates of 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 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 : |
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