AN ISO/IEC - 17025 STANDARD - NABL ACCREDITATION LABORATORY / TRAINING AND CERTIFICATION - MECH - CIVIL - ELECTRICAL & IT COURSES / A to Z LABORATORY TESTING SERVICES / INSPECTION SERVICES / ALL ENGINEERING CONTRACTORS / MORE THAN 1500 SERVICES ...

CLEAN ROOM AND HVAC AHU VALIDATION
 
 
 
CLEAN ROOM and HVAC VALIDATION / AHU VALIDATION / QUALIFICATION
 
  • * HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.
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    CLEANROOM CERTIFICATION
     
  • Validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:
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    Monitor And Control
     
  • A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
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  • Methods for evaluation and measurements for Certification are specified in ISO : 14644-3. It calls out for the following ten tests.
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  • Air flow Test & ACPH Calculations
  • Installed Filter System Leakage Test (using PAO)
  • Non-Viable Particle Count Test
  • Recovery Test
  • Air Flow Pattern Test (Using Water Fogger)
  • Air Pressure Balancing
  • Containment test
  • Temperature & RH Measurement
  • Light Intensity Measurement
  • Sound Level Measurement
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    Range of services pertaining to Clean Room Validation
     
  • High Pressure Diffuser
  • FOG Generator
  • Handy Camera
  • Particle Counter
  • Aerosol Photometer
  • Aerosol Generator
  • Air Capture Hood
  • Vane Type Anemometer
  • Laminar Air Flow Unit (LAF)
  • Reverse Laminar Air Flow Unit (RLAF)
  • Dispensing/Sampling Booth
  • Bio Safety Cabinet
  • Garment Cubicle
  • Sterilizing Tunnel
  • Dry Heat Sterilizer (DHS)
  • Animal Changing Station
  • Individual Ventilation Cage (IVC Unit)
  • Fluid Bed drier (FBD)
  • Autocoater – Tablet Coating machine
  • ULPA Filter Integrity test
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    HVAC Validation includes following Tests:
     
  •  Air Velocity Test
  •  Filter Leak Test
  •  Air Flow Pattern Test
  •  Non viable Particle Count
  •  Viable Particle Count
  •  Recovery Test
  •  Differential Pressure Monitoring
  •  Temperature & Relative Humidity Monitoring
  •  Noise & Light Level Measurement
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    What is validation?
     
  • Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
  • In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results
  • Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.
  • It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
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    Validation Services
     
  • Clean Room and HVAC/AHU Validation/Qualification
  • Compressed Air/Nitrogen Gas Testing or Validation
  • Pure steam Quality test
  • Documentation services
  • Equipment validation
  • Facilities validation
  • HVAC system validation
  • Cleaning validation
  • Process Validation
  • Analytical method validation
  • Computer system validation
  • Packaging validation
  • Cold chain validation
  • Compressed Air Validation
  • HVAC Validation
  • Clean Room Validation
  • Cold chain Validation
  • PLC Validation
  • Thermal Validation
  • Steam Quality Test
  • Design validation services
  • Pharma Validation Services
  • Data-verification validation services
  • Clean Room AHU Area Validation Services
  • Calibration validation
  • Equipment Validation Services
  • Flow Calibration
  • IAQ - Indoor Air Quality
  • Isolator Validation
  • Biosafety, LAF Validation
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    The Validation Process:
     
  • The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
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    Design qualification (DQ)
     
  • Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
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    Installation qualification (IQ)
     
  • Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
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    Operational qualification (OQ)
     
  • Demonstrates that all facets of the process or equipment are operating correctly.
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    Performance qualification (PQ)
     
  • Demonstrates that the process or equipment performs as intended in a consistent manner over time.
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    Component qualification (CQ)
     
  • This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
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    Validation List
     
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    Validation Services List
     
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