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 ...

HVAC 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.
  •  
    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:
  •  
    Monitor And Control
     
  • A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
  •  
  • Methods for evaluation and measurements for Certification are specified in ISO : 14644-3. It calls out for the following ten tests.
  •  
  • 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
  •  
    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
  •  
    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
  •  
    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:
  •  
    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
  •  
    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:
  •  
    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.
  •  
    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.
  •  
    Operational qualification (OQ)
     
  • Demonstrates that all facets of the process or equipment are operating correctly.
  •  
    Performance qualification (PQ)
     
  • Demonstrates that the process or equipment performs as intended in a consistent manner over time.
  •  
    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.
  •  
    Validation List
     
    Clean Room Validation Validation in belize , HVAC Validation Validation in belize , AHU Validation Validation in belize , Qualification Validation in belize , Mep Validation in belize , Heating ventilation and air conditioning Validation in belize , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation in belize , Validation, Qualification and Calibration , Validation tests for hvac system , Validation Qualification Services , Qualification and Validation in belize , Compressed Air Validation in belize , Nitrogen Gas Testing or Validation in belize , Pure steam Quality test Validation in belize , Documentation services Validation in belize , Equipment Validation in belize , Facilities Validation in belize , HVAC system Validation in belize , Cleaning Validation in belize , process Validation in belize , Analytical method Validation in belize , Computer system Validation in belize , Packaging Validation in belize , Cold chain Validation in belize , compressed Air Validation in belize , HVAC Validation in belize , Clean Room Validation in belize , cold chain Validation in belize , PLC Validation in belize , Thermal Validation in belize , Steam Quality Test , Design Validation in belize , Pharma Validation in belize , Data verification Validation in belize , Clean Room AHU Area Validation in belize , Calibration Validation in belize , Equipment Validation in belize , Flow Calibration Validation in belize , IAQ Indoor Air Quality Validation in belize , Equipment validation, Facilities Validation in belize , HVAC system Validation in belize , Cleaning Validation in belize , Process Validation in belize , Analytical method Validation in belize , Computer system Validation in belize , Design qualification (DQ) , Component qualification (CQ) , Installation qualification (IQ) , Operational qualification (OQ) , Performance qualification (PQ) , Pharmaceutical Process Validation in belize , Prospective Validation in belize , Concurrent Validation in belize , Retrospective Validation in belize , Revalidation Periodic and After Change Validation in belize , Compressed Air Validation in belize , HVAC Validation in belize , Clean Room Validation in belize , PLC Validation in belize , thermal Validation in belize , Steam Quality Test , design Validation in belize , pharmaceutical Validation in belize , data verification Validation in belize , Clean Room AHU Area Validation in belize , Calibration Validation in belize , Equipment Validation in belize , IAQ Indoor Air Quality Validation in belize , IAQ Indoor Air Quality Validation in belize ...
     
    Validation Services List
     
    Clean Room validation Services in belize , HVAC validation Services in belize , AHU Validation Services in belize , Qualification validation Services in belize , Mep validation Services in belize , Heating ventilation and air conditioning validation Services in belize , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in belize , Validation, Qualification and Calibration , Validation tests for hvac system Services in belize ,, Validation Qualification Services in belize , Qualification and Validation Services in belize , Compressed Air Validation Services in belize , Nitrogen Gas Testing or Validation Services in belize , Pure steam Quality test Validation Services in belize , Documentation services Validation Services in belize , Equipment validation Services in belize , Facilities validation Services in belize , HVAC system validation Services in belize , Cleaning validation Services in belize , process Validation Services in belize , Analytical method validation Services in belize , Computer system validation Services in belize , Packaging validation Services in belize , Cold chain validation Services in belize , compressed Air Validation Services in belize , HVAC Validation Services in belize , Clean Room Validation Services in belize , cold chain Validation Services in belize , PLC Validation Services in belize , Thermal Validation Services in belize , Steam Quality Test Services in belize , Design validation Services in belize , Pharma Validation Services in belize , Data verification validation Services in belize , Clean Room AHU Area Validation Services in belize , Calibration validation Services in belize , Equipment Validation Services in belize , Flow Calibration Validation Services in belize , IAQ Indoor Air Quality Validation Services in belize , Equipment validation Services in belize , Facilities validation Services in belize , HVAC system validation Services in belize , Cleaning validation Services in belize , Process Validation Services in belize , Analytical method validation Services in belize , Computer system validation Services in belize , Design qualification (DQ) Services in belize , Component qualification (CQ) Services in belize , Installation qualification (IQ) Services in belize , Operational qualification (OQ) Services in belize , Performance qualification (PQ) Services in belize , Pharmaceutical Process Validation Services in belize , Prospective Validation Services in belize , Concurrent Validation Services in belize , Retrospective Validation Services in belize , Revalidation Periodic and After Change validation Services in belize , Compressed Air Validation Services in belize , HVAC Validation Services in belize , Clean Room Validation Services in belize , PLC Validation Services in belize , thermal validation Services in belize , Steam Quality Test Services in belize, design validation Services in belize , pharmaceutical validation Services in belize , data verification validation Services in belize , Clean Room AHU Area Validation Services in belize , Calibration validation Services in belize , Equipment Validation Services in belize , IAQ Indoor Air Quality Validation Services in belize , IAQ Indoor Air Quality Validation Services in belize ...
     
    list of our services following cities
     
    belize city | san ignacio | orange walk | belmopan | dangriga | corozal | san pedro | benque viejo el carmen | punta gorda | placencia | shipyard | valley of peace | belize city | orange walk | belmopan | san ignacio | san pedro | dangriga | corozal | ladyville | punta gorda | trial farm | bullet tree falls | santa familia | consejo | maya beach | camelote | benque viejo el carmen | san estevan | san pablo | guinea grass | blue creek village | salt creek | nago bank | more force | white hill | isabella | flowers bank | hattieville | lime walk | sand hill | egypt | bermudian landing | scotland | corozalito | maskall | biscayne | butcher burns | bakers | cedar bank | davis bank | santana | bomba | burrell boom | lucky strike | little bermudian landing | washing tree | ferguson bank | grace bank | watters bank | rockstone pond | caye corker | may pen | rockville | gales point | bocotora | tropical park | cowhead creek | joe wagner boom | freetown sibun | chicago | gracy rock bank | bob eiley | santiago jalacte | rancho | bacalar chico | san antonio | estrella | pueblo nuevo | chunch | carolina | benque viejo | campa pita | shipstern | yo chen | cowpen | cocos | cristo rey | remate | chan chen | tacistal | san francisco | puebla nueva | santa rita | san pedro | rancho corozal | villa alfonso | aventura | chunox | san joaquin | patchchacan | concepcion | libertad | chacan chac mol | calcutta | shipstern landing | hill bank | louisville | san andres | sarteneja | laguna | san fernando ....