Scribd Logo
Upload

Welcome to Scribd!

  • 100 views

    VTD Urs

    Uploaded by

    produksiqa afifarma
    This document outlines requirements for a vacuum tray dryer including its capacity, purpose, operational requirements, GMP requirements, safety requirements, and documentation needs. It provides details on material specifications, cleaning methods, utilities required, and defines roles and responsibilities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    VTD Urs

    Uploaded by

    produksiqa afifarma
    100 views7 pages
    This document outlines requirements for a vacuum tray dryer including its capacity, purpose, operational requirements, GMP requirements, safety requirements, and documentation needs. It provides details on material specifications, cleaning methods, utilities required, and defines roles and responsibilities.

    Original Title

    64465941-VTD-URS

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document outlines requirements for a vacuum tray dryer including its capacity, purpose, operational requirements, GMP requirements, safety requirements, and documentation needs. It provides details on material specifications, cleaning methods, utilities required, and defines roles and responsibilities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    100 views7 pages

    VTD Urs

    Uploaded by

    produksiqa afifarma
    This document outlines requirements for a vacuum tray dryer including its capacity, purpose, operational requirements, GMP requirements, safety requirements, and documentation needs. It provides details on material specifications, cleaning methods, utilities required, and defines roles and responsibilities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 7

    USER REQUIREMENT

    SPECIFICATION
    (URS)

    Equipment : Vacuum tray dryer


    Location : MPS Block
    Equipment Location : Pharma Ground Floor
    Document No :
    Issued on :

    Page 1 of 7
    TABLE OF CONTENTS

    Sr. No. Description Page No.


    1.0 Protocol Pre-approval 3

    2.0 Objective 4

    3.0 Scope of document 4

    4.0 Responsibility’s 4

    5.0 Process / product requirements 5

    6.0 Operational requirements 5

    7.0 GMP requirements 5

    8.0 Safety Requirement 6

    9.0 Documentation requirements 6

    10.0 Abbreviation 7

    11.0 Discussion review and comments 7

    Page 2 of 7
    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
    Executive
    (Production)
    Checked by
    (Utility & Manager
    Maintenance)
    Verified by
    Manager.
    (Production)

    Reviewed by
    (Quality Executive
    Assurance)

    Approved by
    (Quality Manager
    Assurance)

    Page 3 of 7
    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 Responsibility’s

    4.1 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).

    4.2 Responsibility of manufacturer

    • 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.

    Page 4 of 7
    5.0 Process / product requirements

    Name of the Equipments Vacuum tray dryer


    Capacity 48 tray
    Purpose of the Equipment To undertake drying of various API product in
    MPS block
    Drying Temp. Up to 80OC
    Chemical/ Physical Characteristics of the The material to be processed in the subjected
    process materials dryer could be fine powder or crystalline
    powder having moisture content up to 20%
    Any other Specific Requirement • 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

    6.0 Operational requirements

    Production stage The subjected equipment would be utilized for


    drying of various API product in API pharma
    block
    Expected operation Hr./day 20 hour
    Operation control Through PLC and interference via HMI
    Utilities Required Standard Power supply, air and steam as
    suggested by the supplier
    Cleaning method Manual

    7.0 GMP requirements

    7.1 Specification of material of construction

    Product contact surface SS 316


    Indirect contact surface SS 316
    Non contact surface S.S. 304 / any other suitable material
    Seal gasket etc. Silicon, PTFE

    Page 5 of 7
    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.

    8.0 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

    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

    Page 6 of 7
    10.0 Abbreviation:

    URS : Users requirement specification


    cGMP : Current Good manufacturing practice
    P&ID : Piping and instrumentation diagram
    ASME : American society of mechanical Engineers
    GEP : Good engineering practice
    CIP : Clean in place
    MOC : Material of construction
    FLP : Flam proof
    VFD : variable frequency drive
    MS : Mild steel
    SS : Staleness steel
    CS : Carbon steel
    RPM : Rotation per minute
    MM : millimeter
    KL : kiloliters
    DQ : Design qualification
    IQ : Installation qualification
    OP : Operation qualification
    PQ : Performance qualification
    FAT : Factory acceptance test
    SAT : Site acceptance test
    PP : Poly propylene
    PFD : Process Flow Diagram
    O/M : Operation / maintenance
    P&ID : Piping and instrumentation diagram
    SOP : Standard operating procedure
    0C : Degrees Centigrade
    Temp. : Temperature
    PG : Pressure gauge
    VG : Vacuum gauge
    HP : Horse power
    KW : Kilowatt

    11.0 Discussion/ review/ comment

    Page 7 of 7

    You might also like