User Requirement Specifications for HVAC System

User Approval

Name	Signature	Date
Prepared By: Production Manager
Checked By: Plant Manager
Checked By: Engineering Manager
Approved By: QA Manager
Authorized By: General Manager

Basic Requirement	PharmaGuide Ltd. Is looking for an HVAC system for solid and liquid facilities at the general production facility.
Capacity	These specifications will cover the details of design, supply, installation, testing, and commissioning. This design must meet all cGMP guidelines and legislation.
Power Supply	415 ± 10 valts, 50 HZ, 3 Phase
Room Condition	Relative Humidity of equipment room: 45 ± 5% Temperature of room: 22 ± 2°C Grade of equipment room: Grade D
Material of Construction	The product contact part of the machine will be made of SS AISI 316L, and other Parts will be SS AISI 304 The surface finish will be at product contact side Ra ≤ 0.3 µm and for non-contact side Ra ≤ 0.8 µm
Process Requirements	This HVAC system should be applicable for general Production facilities - solid and liquid products of PharmaGuide Ltd. Facility comprises air handling systems that provide heating, ventilation,   and air conditioning. This is achieved by controlling the pressure, temperature, humidity, flow rate, flow pattern, and cleanliness of the various areas. Monitoring and controlling systems are employed to ensure optimum conditions are maintained. The air conditioning system has been designed and installed to provide air-conditioned particulate-controlled air to all rooms within the facility. Air conditioning systems should be located on the roof of the building and the position of AHU will be 8 ft above the room ceiling above the production area.
Process Control	Air exhaust systems including dust extraction systems should be incorporated. Removal of waste water should have an adequate drainage facility. Lighting should be sufficient. During operation, if the spray nozzle gets clogged the machine should have a cleaning system of nozzle in place. There should be an automatic alarm system if there is any malfunctioning, and a reset button shall be provided.
Emergency Stop	The E-Stop mechanism shall be located in easily accessible areas around the equipment as required by national and local safety standards.
Sound Level	Not more than 75db
Cleaning	An automatic CIP system with PW should be provided.
Control System and Automation	The machine should be PLC controlled with color touch HMI. To avoid operating errors, the user software will be designed to operate in four clearly separated operation modes, i.e. Manual operation Automatic operation Cleaning Maintenance The access to each operation mode has to be controlled by password protection. The system will allow the following identifications: Date Product name Batch Number Operator ID Time setting to start and end of a cycle. The language requirement is English.
Drawing & Protocols	DQ, IQ, and OQ protocols will be supplied by the vendor and executed by PharmaGuide Limited and the Vendor. The vendor is to provide all necessary protocols which will be approved by PharmaGuide Limited. The following documents will be supplied by the vendor: Installation Manual (2 Copies) Operational Manual (2 Copies) Service Manual (2 Copies) Routine maintenance schedule and recommended change parts list. All necessary drawings (i.e., P&I diagram, Electrical and pneumatic wiring diagram, Equipment Layout, Assembly and disassembling drawings, etc. Complete component lists including origin. Instrument calibration certificate with manual All materials Certificate. Spares parts list. Note: All documents have to comply with the cGMP standard.
Factory Acceptance Test (FAT)	PharmaGuide personnel and vendor jointly execute the Factory Acceptance Test at the vendor's site. The Supplier shall notify the PharmaGuide 4 weeks before FAT. The FAT protocol shall be submitted to the user for review and approval a minimum of 2 weeks ahead of FAT.
Site Acceptance Test (SAT)	SAT shall be executed by the vendor jointly with PharmaGuide personnel at the PharmaGuide site.
Spares	Frequently degradable change parts for two years.
Warranty	12 months of support service ensuring the smooth running of the machine.

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