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.
  •  
    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 bangladesh , HVAC Validation Validation in bangladesh , AHU Validation Validation in bangladesh , Qualification Validation in bangladesh , Mep Validation in bangladesh , Heating ventilation and air conditioning Validation in bangladesh , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation in bangladesh , Validation, Qualification and Calibration , Validation tests for hvac system , Validation Qualification Services , Qualification and Validation in bangladesh , Compressed Air Validation in bangladesh , Nitrogen Gas Testing or Validation in bangladesh , Pure steam Quality test Validation in bangladesh , Documentation services Validation in bangladesh , Equipment Validation in bangladesh , Facilities Validation in bangladesh , HVAC system Validation in bangladesh , Cleaning Validation in bangladesh , process Validation in bangladesh , Analytical method Validation in bangladesh , Computer system Validation in bangladesh , Packaging Validation in bangladesh , Cold chain Validation in bangladesh , compressed Air Validation in bangladesh , HVAC Validation in bangladesh , Clean Room Validation in bangladesh , cold chain Validation in bangladesh , PLC Validation in bangladesh , Thermal Validation in bangladesh , Steam Quality Test , Design Validation in bangladesh , Pharma Validation in bangladesh , Data verification Validation in bangladesh , Clean Room AHU Area Validation in bangladesh , Calibration Validation in bangladesh , Equipment Validation in bangladesh , Flow Calibration Validation in bangladesh , IAQ Indoor Air Quality Validation in bangladesh , Equipment validation, Facilities Validation in bangladesh , HVAC system Validation in bangladesh , Cleaning Validation in bangladesh , Process Validation in bangladesh , Analytical method Validation in bangladesh , Computer system Validation in bangladesh , Design qualification (DQ) , Component qualification (CQ) , Installation qualification (IQ) , Operational qualification (OQ) , Performance qualification (PQ) , Pharmaceutical Process Validation in bangladesh , Prospective Validation in bangladesh , Concurrent Validation in bangladesh , Retrospective Validation in bangladesh , Revalidation Periodic and After Change Validation in bangladesh , Compressed Air Validation in bangladesh , HVAC Validation in bangladesh , Clean Room Validation in bangladesh , PLC Validation in bangladesh , thermal Validation in bangladesh , Steam Quality Test , design Validation in bangladesh , pharmaceutical Validation in bangladesh , data verification Validation in bangladesh , Clean Room AHU Area Validation in bangladesh , Calibration Validation in bangladesh , Equipment Validation in bangladesh , IAQ Indoor Air Quality Validation in bangladesh , IAQ Indoor Air Quality Validation in bangladesh ...
     
    Validation Services List
     
    Clean Room validation Services in bangladesh , HVAC validation Services in bangladesh , AHU Validation Services in bangladesh , Qualification validation Services in bangladesh , Mep validation Services in bangladesh , Heating ventilation and air conditioning validation Services in bangladesh , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in bangladesh , Validation, Qualification and Calibration , Validation tests for hvac system Services in bangladesh ,, Validation Qualification Services in bangladesh , Qualification and Validation Services in bangladesh , Compressed Air Validation Services in bangladesh , Nitrogen Gas Testing or Validation Services in bangladesh , Pure steam Quality test Validation Services in bangladesh , Documentation services Validation Services in bangladesh , Equipment validation Services in bangladesh , Facilities validation Services in bangladesh , HVAC system validation Services in bangladesh , Cleaning validation Services in bangladesh , process Validation Services in bangladesh , Analytical method validation Services in bangladesh , Computer system validation Services in bangladesh , Packaging validation Services in bangladesh , Cold chain validation Services in bangladesh , compressed Air Validation Services in bangladesh , HVAC Validation Services in bangladesh , Clean Room Validation Services in bangladesh , cold chain Validation Services in bangladesh , PLC Validation Services in bangladesh , Thermal Validation Services in bangladesh , Steam Quality Test Services in bangladesh , Design validation Services in bangladesh , Pharma Validation Services in bangladesh , Data verification validation Services in bangladesh , Clean Room AHU Area Validation Services in bangladesh , Calibration validation Services in bangladesh , Equipment Validation Services in bangladesh , Flow Calibration Validation Services in bangladesh , IAQ Indoor Air Quality Validation Services in bangladesh , Equipment validation Services in bangladesh , Facilities validation Services in bangladesh , HVAC system validation Services in bangladesh , Cleaning validation Services in bangladesh , Process Validation Services in bangladesh , Analytical method validation Services in bangladesh , Computer system validation Services in bangladesh , Design qualification (DQ) Services in bangladesh , Component qualification (CQ) Services in bangladesh , Installation qualification (IQ) Services in bangladesh , Operational qualification (OQ) Services in bangladesh , Performance qualification (PQ) Services in bangladesh , Pharmaceutical Process Validation Services in bangladesh , Prospective Validation Services in bangladesh , Concurrent Validation Services in bangladesh , Retrospective Validation Services in bangladesh , Revalidation Periodic and After Change validation Services in bangladesh , Compressed Air Validation Services in bangladesh , HVAC Validation Services in bangladesh , Clean Room Validation Services in bangladesh , PLC Validation Services in bangladesh , thermal validation Services in bangladesh , Steam Quality Test Services in bangladesh, design validation Services in bangladesh , pharmaceutical validation Services in bangladesh , data verification validation Services in bangladesh , Clean Room AHU Area Validation Services in bangladesh , Calibration validation Services in bangladesh , Equipment Validation Services in bangladesh , IAQ Indoor Air Quality Validation Services in bangladesh , IAQ Indoor Air Quality Validation Services in bangladesh ...
     
    list of our services following cities
     
    Afghanistan | Africa | Albania | Algeria | Americas | Andorra | Angola | Anguilla | Antigua and Barbuda | Argentina | Armenia | Aruba | Asia | Australia | Australia and New Zealand | Austria | Azerbaijan | Bahamas | Bahrain | Bangladesh | Barbados | Belarus | Belgium | Belize | Benin | Bermuda | Bhutan | Bolivia (Plurinational State of) | Bosnia and Herzegovina | Botswana | Brazil | British Virgin Islands | Brunei Darussalam | Bulgaria | Burkina Faso | Burundi | Cabo Verde | Cambodia | Cameroon | Canada | Caribbean | Cayman Islands | Central African Republic | Central America | Central Asia | Chad | Chile | China, Hong Kong SAR | China, Macao Special Administrative Region | China, People's Republic of | Colombia | Comoros | Congo | Cook Islands | Costa Rica | Côte d'Ivoire | Croatia | Cuba | Curaçao | Cyprus | Czechia | Democratic People's Republic of Korea | Democratic Republic of the Congo | Denmark | Djibouti | Dominica | Dominican Republic | Eastern Africa | Eastern Asia | Eastern Europe | Ecuador | Egypt | El Salvador | Equatorial Guinea | Eritrea | Estonia | Ethiopia | Europe | Fiji | Finland | Former Czechoslovakia | Former Ethiopia | Former Netherlands Antilles | Former Sudan | Former USSR | Former Yugoslavia | France | French Polynesia | Gabon | Gambia | Georgia | Germany | Ghana | Greece | Greenland | Grenada | Guatemala | Guinea | Guinea-Bissau | Guyana | Haiti | Honduras | Hungary | Iceland | India | Indonesia | Iran, Islamic Republic of | Iraq | Ireland | Israel | Italy | Jamaica | Japan | Jordan | Kazakhstan | Kenya | Kingdom of Eswatini | Kiribati | Kosovo | Kuwait | Kyrgyzstan | Lao People's Democratic Republic | Latin America and the Caribbean | Latvia | Lebanon | Lesotho | Liberia | Libya | Liechtenstein | Lithuania | Luxembourg | Madagascar | Malawi | Malaysia | Maldives | Mali | Malta | Marshall Islands | Mauritania | Mauritius | Melanesia | Mexico | Micronesia | Micronesia (Federated States of) | Middle Africa | Monaco | Mongolia | Montenegro | Montserrat | Morocco | Mozambique | Myanmar | Namibia | Nauru | Nepal | Netherlands | New Caledonia | New Zealand | Nicaragua | Niger | Nigeria | Northern Africa | Northern America | Northern Europe | Norway | Oceania | Oman | Pakistan | Palau | Panama | Papua New Guinea | Paraguay | Peru | Philippines | Poland | Polynesia | Portugal | Puerto Rico | Qatar | Republic of Korea | Republic of Moldova | Republic of North Macedonia | Romania | Russian Federation | Rwanda | Saint Kitts and Nevis | Saint Lucia | Saint Vincent and the Grenadines | Samoa | San Marino | Sao Tome and Principe | Saudi Arabia | Senegal | Serbia | Seychelles | Sierra Leone | Singapore | Sint Maarten (Dutch part) | Slovakia | Slovenia | Solomon Islands | Somalia | South Africa | South America | South Sudan | South-Eastern Asia | Southern Africa | Southern Asia | Southern Europe | Spain | Sri Lanka | State of Palestine | Sub-Saharan Africa | Sudan | Suriname | Sweden | Switzerland | Syrian Arab Republic | Tajikistan | Thailand | Timor-Leste | Togo | Tonga | Trinidad and Tobago | Tunisia | Turkey | Turkmenistan | Turks and Caicos Islands | Tuvalu | Uganda | Ukraine | United Arab Emirates | United Kingdom of Great Britain and Northern Ireland | United Republic of Tanzania: Mainland | United Republic of Tanzania: Zanzibar | United States | Uruguay | Uzbekistan | Vanuatu | Venezuela (Bolivarian Republic of) | Viet Nam | Western Africa | Western Asia | Western Europe | World | Yemen | Yemen: Former Democratic Yemen | Yemen: Former Yemen Arab Republic | Zambia | Zimbabwe ...
     
    list of our services following city and District
     
    Dhaka | Chittagong | Khulna | Rajshahi | Gazipur | Sylhet | Mymensingh | Barisal | Rangpur | Comilla | Narayanganj | Bogra | Kushtia | Jessore | Cox's Bazar | Manikganj | Brahmanbaria | Dinajpur | Nawabganj | Tangail | Sirajganj | Chandpur | Feni | Jamalpur | Naogaon | Narsingdi | Pabna | Maijdee | Faridpur | Jhenaidah | Satkhira ...
     
    list of our services following urban Areas
     
    Barisal Division | Bhola | Patuakhali | Pirojpur | Jhalokati | Barguna | Amtali | Bakerganj | Char Fasson | Gournadi | Swarupkati | Kuakata | Muwallad | Bhandaria | Mathbaria | Lalmohan | Borhanuddin | Daulatkhan | Banaripara | Mehendiganj | Nalchity | Patharghata | Kalapara | Chittagong Division | Chhagalnaiya | Daganbhuiyan | Parshuram | Sonagazi | Bandarban | Khagrachhari | Rangamati | Rangunia | Sandwip | Fatikchhari | Nazir Hat | Baroiyarhat | Mirsharai | Sitakunda | Hathazari | Raozan | Patiya | Brahmanpara Upazila | Chandanaish | Satkania | Boalkhali | Akhaura | Sarail | Chowmuhani | Laksam | Hatiya | Maijdee | Lakshmipur | Burichong | Dhaka Division | Ghorashal | Monohardi | Shibpur | Raipura | Madhabdi | Mirzapur | Dhanbari | Madhupur | Gopalpur | Ghatail | Kalihati | Sakhipur | Bhuapur | Elenga | Karatia | Aricha | Basail | Bhairab | Kishoreganj | Manikganj | Munshiganj | Gopalganj | Shariatpur | Madaripur | Rajbari | Baliakandi | Pangsha | Khulna Division | Bagherhat | Chuadanga | Darshana, | Chuadanga | Jhenaidah | Kaliganj | Magura | Meherpur | Narail | Noapara | Shatkhira | Mymensingh Division | Shambhuganj | Muktagachha | Bhaluka | Gouripur | Phulpur | Trishal | Nandail | Gaffargaon | Ishwarganj | Haluaghat | Fulbaria | Netrokona | Sherpur | Rajshahi Division | Joypurhat | Rahanpur | Kalai | Khetlal | Akkelpur | Panchbibi | Mundumala | Naogaon | Natore | Shahjadpur | Ullapara | Iswardi | Santhia | Dhunat | Sherpur | Bogra | Tanore | Rangpur Division | Gaibandha | Kurigram | Lalmonirhat | Nilphamari | Panchagarh | Thakurgaon | Saidpur | Sylhet Division | Golapganj | Habiganj | Maulvibazar | Sreemangal | Sunamganj | Beanibazar | Barlekha | Zakiganj | Chhatak | Balagonj | Osmaninogor | Joggonathpur | Bisawanth ....