USER REQUIREMENT SPECIFICATION

(URS)
Equipment Location Equipment Location Document No Issued on : : : : : Vacuum tray dryer MPS Block Pharma Ground Floor

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TABLE OF CONTENTS
Sr. No. Description
1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 Protocol Pre-approval Objective Scope of document Responsibilitys Process / product requirements Operational requirements GMP requirements Safety Requirement Documentation requirements Abbreviation Discussion review and comments

Page No.
3 4 4 4 5 5 5 6 6 7 7

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1.0 PRE-APPROVAL The pre-approval of this Users requirement Specification Protocol shall be the joint responsibility of the following:

DESIGNATION

NAME

SIGNATURE & DATE

Prepared by (Production) Checked by (Utility & Maintenance) Verified by (Production) Reviewed by (Quality Assurance) Approved by (Quality Assurance)

Executive Manager Manager.

Executive

Manager

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2.0

Objective

Objective of this user requirement specification is to define the requirements of process, operational, safety and cGMP for vacuum tray dryer including all ancillary items.

3.0

Scope of document

This user requirement specification will be recognized to illustrate the design with the necessary requirements of vacuum tray dryer an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document.

4.0
4.1

Responsibilitys
Responsibility of User requirement specification is to be prepared by end user with support from project Engineer for required equipment / instrument in-house. User requirement specification is to be submitted to vendors. Prepared P & ID & provide the vender (If required). Provide the room layout (If required by Vender). Responsibility of manufacturer

4.2

The complete design shall meet with technical, GMP and specific requirements. Operation and maintenance manual is to be provided by the manufacturer. Test certificate, calibration certificate required as per the design of the particular equipment/instrument is to be provided. On-site training shall be provided by the manufacturer.

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5.0

Process / product requirements

Vacuum tray dryer 48 tray To undertake drying of various API product in MPS block Up to 80OC The material to be processed in the subjected dryer could be fine powder or crystalline powder having moisture content up to 20% Suitable vacuum pump to be provided PLC and MMI is to be provided for controlling and monitoring of the system Condenser and receiver to be provided for colleting the distilled material Printing pot and printer to be provided for printer How water generation system to be provided

Name of the Equipments Capacity Purpose of the Equipment Drying Temp. Chemical/ Physical Characteristics of the process materials Any other Specific Requirement

6.0

Operational requirements
The subjected equipment would be utilized for drying of various API product in API pharma block 20 hour Through PLC and interference via HMI Standard Power supply, air and steam as suggested by the supplier Manual

Production stage Expected operation Hr./day Operation control Utilities Required Cleaning method

7.0 7.1

GMP requirements
Specification of material of construction SS 316 SS 316 S.S. 304 / any other suitable material Silicon, PTFE

Product contact surface Indirect contact surface Non contact surface Seal gasket etc.

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7.2

Specific GMP requirement Validation port to be provided Manufacturers name and address, specifications of equipment, equipment serial number date of manufacturing to appear on sign plate of equipment Free from pinholes, plugs, crevices, sharp edges Internal surface finish of the equipment should be smooth as per glass standard. Provide the FAT / Verify the equipment design to the supplier. Safety Requirement All electric component should comply to I.P. 67 requirement Guard/ protection cover for all moving parts Electrical panel to be installed in on multi mill skid

8.0

9.0

Document requirements The manufacturer shall complete and provide the documents pertaining to Design, Installation & Operation Qualification and detail functional specifications. Information on purchased/bought out parts. Material of construction test certificate Calibration certificate DQ & fabrication Drawing

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10.0 URS cGMP P&ID ASME GEP CIP MOC FLP VFD MS SS CS RPM MM KL DQ IQ OP PQ FAT SAT PP PFD O/M P&ID SOP 0C Temp. PG VG HP KW 11.0

Abbreviation: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Users requirement specification Current Good manufacturing practice Piping and instrumentation diagram American society of mechanical Engineers Good engineering practice Clean in place Material of construction Flam proof variable frequency drive Mild steel Staleness steel Carbon steel Rotation per minute millimeter kiloliters Design qualification Installation qualification Operation qualification Performance qualification Factory acceptance test Site acceptance test Poly propylene Process Flow Diagram Operation / maintenance Piping and instrumentation diagram Standard operating procedure Degrees Centigrade Temperature Pressure gauge Vacuum gauge Horse power Kilowatt

Discussion/ review/ comment

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