URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR HPHV STEAM STERILIZER
This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier.
List of Content
- Front Page
- Index
- Approval
- List of general components
- Glossary
- Technical
- General
- Salient features
- Operational requirements
- Utilities
- Maintenance
- Inspection and testing
- Commissioning and documentation
- Training
- Packaging
- Deviations
- Delivery
Note: If any deviation in URS, Vendor/Supplier shall inform before acceptance of URS.
LIST OF GENERAL COMPONENTS:
- Chamber
- Jacket
- Condenser
- Steam Generator
- Vacuum Pump
- Magnehelic Gauges
- Door Open button
- Door Close button
- Auto Sensor
- Power Supply Plug
- Printer
- ON/OFF Switch
- Log data Printer
- Emergency Stop Button
- Switch Socket
TECHNICAL: General Description: HPHV Steam Sterilizer with vertical sliding doors.
Field Identification: Sterilization of Media, Glassware, Garments and other accessories used in the microbiological analysis shall be install at Microbiology Lab.
Salient Features:
General Unit to be compact with ease of operation.
A closed system with consistent performance.
Ease of maintenance
Easily cleanable with minimum recesses and crevices.
All welded joints to be grinded where product may be in contact to smooth finish and lead free.
All gaskets provided to avoid leakages should be amendable for easy removal and re-fixing,
All electrical/pneumatic parts should be pre wired.
Convenient lubrication design
Complete safety interlock design
All bolts, nuts on the exterior part of equipment to be preferably with cap head or cap nut.
Parts, which are required for cleaning, should be provided with quick fixing arrangement.
Material of Construction: SS304/SS 316 L
Finish – Visually good
Electrical Construction – non-flameproof / flameproof.
Operational requirements: Operating requirement-based capacity mentioned below:
(W) 600mm X (D) 900mm X (H) 600mm.
Control Parameter
Inbuilt electrical control panel and power panel (material SS 304)
Working Pressure: Upto 2.2 kg/cm2 (g).
Working Temperature: Upto 134 degree Celsius.
Control: Manual & Automatic
Data & Security: Yes, with Password
User interface with supervisors and operators for the control platform Interface with other Equipment and system – 3 Level Password Protection
Security level – The operator interface (MMI) on to the paneling on the loading side.
Data collection: The Printer on to the paneling on the loading side.
The strip chart recorder on to the paneling on the loading side.
Functional Requirements:
AUTO MODE: The following process can be performed automatically through PLC:
- Vacuum Leak Test.
- Bowie and Dick Test.
- Standard Process (Gravity Displacement Program).
- HPHV Process (Pre Vacuum Program with Vacuum Drying).
MANUAL MODE: The above-mentioned processes can be performed manually with rocker switch,
Temperature indicator cum controller and Compound gauges.
Alarm System:
Preferably the sound alarms / beep shall be provided along with light indication. The alarm should be on if
(a) If chamber vacuum leak test is failed.
(b) If the chamber temperature overshoots.
(c) If chamber temperature falls below specified level & the timer stops counting.
(d) If chamber temperature falls further below specified level & the timer resets previously counted time.
(e) If chamber pressure is greater than the set value.
(f) Too long time for heat up.
(g) Too long time for pre vacuum
(h) Too long time for post vacuum.
(i) If vacuum pump trips.
(j) Door pre-condition fails.
Power failure / recovery: 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.
Emergency stop: The emergency stop mechanism(s) shall be provided.
Utilities: Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.
Maintenance: Supplier should provide the following maintenance instructions, Operation and Maintenance manuals along with as built drawings Daily checks on machine cleaning procedures.
Commissioning and Documentation: 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.
Development: The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Training – Supplier to train the respective technical associates on operation, maintenance and cleaning of the equipment wherever applicable.
Training – Supplier to train the respective technical associates on operation, maintenance and cleaning of the equipment wherever applicable.
Start up support: Telephone / Fax / E-mail ID / Address
Post start up support – Replacement parts availability list (normal lead times shall be listed) System improvements (supplier shall notify user of any improvements)
Packaging – Supplier to specify packaging of machine for safe transportation and delivery.
Deviations – Any deviation from URS shall be highlighted.
Delivery: As per purchase order.