Objective of URS for Bio Safety Cabinet
- This document is generating under the authority of the for the purpose of specifying the user requirement for URS for Bio Safety Cabinet. The User Requirements Specification (URS) is provided to define the important components, variables and options necessary for the Supplier to provide a functional of Biosafety Cabinet that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for Biosafety Cabinet including the design, Performance and manufacture of the equipment.
- This URS is an integral part of the procurement agreement with the Supplier.
- The Biosafety Cabinet will be interfaced to the output and will be located in a designated operating area & will comply as per GMP operations
TABLE OF CONTENT
| Description | Page No. |
| Title page | |
| Table of contents | |
| Approval of Documents | |
| Objective | |
| Scope | |
| Location of equipment | |
| Communication | |
| Applicable codes and standard | |
| System/equipment/instruments details | |
| Scope of supply | |
| Brief system description | |
| Technical specification | |
| Safety features | |
| List of Abbreviations |
Approval of Documents:
Prepared by:-
| Name | Designation/Department | Signature | Date |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
Approved by:-
| Name | Designation/Department | Signature | Date |
Scope:
- The scope of this document is to define the requirements of the Biosafety Cabinet in M/s Accent Pharmaceuticals & Diagnostics Vill-Bhalon (Seri), Forest Road, Solan, Himachal Pradesh (INDIA).
References
- The supplier shall use the following references in all communications: –
Applicable Codes and Standards: –
- The entire Supplier’s work shall comply with all relevant Indian and International Standards and Codes of Practice.
- The Supplier shall confirm all the Standards which have been used for the design and manufacture of the equipment.
System/equipment/Instruments details of URS for Bio Safety Cabinet:
| Name of the equipment | Biosafety Cabinet |
| Technical Specification | Compatible to 21 CFR compliance |
| Model/Type | As per GMP model |
Scope of Supply:
| Type of Device | Biosafety Cabinet |
| Machine Standard | The current state of the art GMP Compliance. |
| Machine design standard for safety | EN 12469 – Performance Criteria for Microbiological Safety Cabinets GMP / GLP Guidelines – Pharmaceutical & Laboratory Compliance CE / UL Certification – Electrical & Mechanical Safety (where applicable) |
| Room Condition | Room Temperature: – : NMT 25°C .Relative humidity-:NMT 55% RH (Non-Condensing) |
| Features | Design conforming to cGMP standards. |
| Document & Certificate | Manuals and Maintenance Instructions Operator manual Installation and assembly instructions for all devices. Vendor Technical Specification User’s manuals for all components. Trouble shooting guide. Calibration Certificates Maintenance Manual. Safety instruction. Electrical and P&ID Drawings Training documentation. Equipment Layout / GA Drawing |
| Qualification Protocols | IQ Protocol and reportOQ Protocol and reportPQ Protocol and reportVendor should organize for Execution of IQ, OQ and support for PQ |
| Training | Vendor should impart necessary Operational training to user department and maintenance training to maintenance department. |
| Test, Calibration, Certification | All test certificate for brought items will be provides Documents Standard Followed: NSF-49 / ISO 14644 / EU GMP (as applicable) Reference Instruments Used Anemometer (Air Velocity Meter)Particle Counter Lux Meter Sound Level Meter DOP / PAO Aerosol Generator |
Brief system description of URS for Bio Safety Cabinet:
The Biosafety Cabinet (Class II Type A2) is a ventilated laboratory enclosure designed to provide personnel, product, and environmental protection during microbiological and aseptic operations. The cabinet operates on the principle of vertical laminar airflow combined with high-efficiency HEPA filtration to maintain a sterile and contamination-free working zone.
- Function:
The Biosafety Cabinet (BSC) is designed to provide personnel protection, product protection, and environmental protection during handling of microbiological agents, sterile materials, and bio-hazardous samples. Its primary function is to create a HEPA-filtered sterile working zone with controlled airflow to prevent contamination and exposure
- Chiller/Cooling system:
The Biosafety Cabinet generally does not require an independent chiller; however, provision shall be made to ensure that internal temperature and airflow stability are maintained during continuous operation.
Blower and electrical components shall be designed for low heat generation.
Adequate ventilation slots / heat dissipation design shall be provided.
- Sound enclosure:
The Biosafety Cabinet shall be designed with inbuilt acoustic insulation to ensure comfortable laboratory working conditions and minimal noise disturbance.
The sound enclosure shall ensure reduced noise pollution, operator comfort, and compliance with workplace safety norms while maintaining full functional efficiency of the autoclave.
- Industries:
Biosafety Cabinet are used in diverse industries like pharmaceuticals, Laboratories etc.
Technical Specification of URS for Bio Safety Cabinet:
| Particulars | Specification |
| Class & Type | Class II Type 2A |
| Application | Aseptic and microbiological operations |
| Control System | Microprocessor / Digital ControllerLCD / LED Display PanelAirflow Velocity IndicatorFilter Life IndicatorHour Meter for Blower & UV LampPassword Protected Settings (Optional) |
| Performance Parameter | Noise Level: ≤ 65 dBVibration Level: MinimalIllumination: ≥ 800 Lux at Work SurfaceContinuous Operation Capability: 8–12 Hours |
| Filtration | Supply HEPA Filter Efficiency: 99.97% at 0.3 MicronExhaust HEPA Filter Efficiency: 99.97% at 0.3 MicronFilter Type: Mini-Pleat / Deep-Pleat ReplaceableFilter Integrity Test Port: Provided |
| Power Supply | 230 V ±10%, 50 Hz, Single PhaseInternal Electrical Sockets: 2 Nos. (Minimum)Lighting: LED / Fluorescent Light ≥ 800 LuxUV Lamp: 15–30 W with Time |
| Airflow System | Airflow Type: Vertical Laminar Down flowInflow Velocity: ~0.45 m/s ±20%Down flow Velocity: ~0.30 m/s ±20%Air Recirculation: Approx. 70% Recirculated / 30% Exhaust (Type A2 Standard)Blower Type: Dynamically Balanced, Low Noise Motor |
| Dimensions | Working Width: 3 ft / 4 ft / 6 ft (as per requirement)Internal Height: Approx. 600–700 mmOverall Height: Approx. 2000–2200 mm |
| Construction | Work Area Material: SS 304 / SS 316, seamless finishOuter Body: Epoxy Powder Coated GI / Stainless SteelFront Sash: Toughened UV-Protected Glass, Manual / Motorized Sliding Work Surface: Removable Perforated SS Tray with Spill Collection Facility |
| Identification | Details of Make, Name, Serial.No., Capacity, Model and Year of manufacture should be available. |
Safety Features:
| Critical Variables | Acceptance Criteria | Reference |
| Metal Parts | All the metal parts should be properly grounded without any sharp Edges. | Safety Requirement |
| Leveling and Balancing | Equipment should be properly balanced & leveled. | Safety Requirement |
| Installation | All the Installation must be in accordance with the GMP. | Safety Requirement |
| Electrical Wiring And Earthing | Electrical wiring should be as per approved drawings. Double external Earthing to control machine (panel and motors) and operator should be provided. | Safety Requirement |
| Noise Level | ≤ 65 dB. | Safety Requirement |
| Emergency/Safety Switch | The Biosafety Cabinet shall be designed with adequate safety provisions to protect the operator, product, and environment during routine and abnormal operating conditions. All safety systems shall function automatically and comply with GMP/GLP and applicable international standards. Emergency Shut-Off (if provided): Accessible switch to immediately stop blower and electrical supply during emergency. Electrical Safety: Proper earthing, overload protection, and short-circuit protection. | Safety Requirement |
| Alarm & Warning | Audio-Visual Alarm System: For unsafe conditions such as airflow failure, sash misalignment, or system malfunction.HEPA Filter Choke Alarm: Visual and audible alert when filter pressure drop exceeds acceptable limits. | Safety Requirement |
List of Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| MOC | Management of change |
| FAT | Factory Acceptance Test |
| SAT | Site Acceptance Test |
| QA | Quality Assurance |
| cGMP | Current Good manufacturing |
| Ltr | Litre |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |