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 nigeria ,
HVAC Validation Validation in nigeria ,
AHU Validation Validation in nigeria ,
Qualification Validation in nigeria ,
Mep Validation in nigeria ,
Heating ventilation and air conditioning Validation in nigeria ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation in nigeria ,
Validation, Qualification and Calibration ,
Validation tests for hvac system ,
Validation Qualification Services ,
Qualification and Validation in nigeria ,
Compressed Air Validation in nigeria ,
Nitrogen Gas Testing or Validation in nigeria ,
Pure steam Quality test Validation in nigeria ,
Documentation services Validation in nigeria ,
Equipment Validation in nigeria ,
Facilities Validation in nigeria ,
HVAC system Validation in nigeria ,
Cleaning Validation in nigeria ,
process Validation in nigeria ,
Analytical method Validation in nigeria ,
Computer system Validation in nigeria ,
Packaging Validation in nigeria ,
Cold chain Validation in nigeria ,
compressed Air Validation in nigeria ,
HVAC Validation in nigeria ,
Clean Room Validation in nigeria ,
cold chain Validation in nigeria ,
PLC Validation in nigeria ,
Thermal Validation in nigeria ,
Steam Quality Test ,
Design Validation in nigeria ,
Pharma Validation in nigeria ,
Data verification Validation in nigeria ,
Clean Room AHU Area Validation in nigeria ,
Calibration Validation in nigeria ,
Equipment Validation in nigeria ,
Flow Calibration Validation in nigeria ,
IAQ Indoor Air Quality Validation in nigeria ,
Equipment validation,
Facilities Validation in nigeria ,
HVAC system Validation in nigeria ,
Cleaning Validation in nigeria ,
Process Validation in nigeria ,
Analytical method Validation in nigeria ,
Computer system Validation in nigeria ,
Design qualification (DQ) ,
Component qualification (CQ) ,
Installation qualification (IQ) ,
Operational qualification (OQ) ,
Performance qualification (PQ) ,
Pharmaceutical Process Validation in nigeria ,
Prospective Validation in nigeria ,
Concurrent Validation in nigeria ,
Retrospective Validation in nigeria ,
Revalidation Periodic and After Change Validation in nigeria ,
Compressed Air Validation in nigeria ,
HVAC Validation in nigeria ,
Clean Room Validation in nigeria ,
PLC Validation in nigeria ,
thermal Validation in nigeria ,
Steam Quality Test ,
design Validation in nigeria ,
pharmaceutical Validation in nigeria ,
data verification Validation in nigeria ,
Clean Room AHU Area Validation in nigeria ,
Calibration Validation in nigeria ,
Equipment Validation in nigeria ,
IAQ Indoor Air Quality Validation in nigeria ,
IAQ Indoor Air Quality Validation in nigeria ...
Validation Services List
Clean Room validation Services in nigeria ,
HVAC validation Services in nigeria ,
AHU Validation Services in nigeria ,
Qualification validation Services in nigeria ,
Mep validation Services in nigeria ,
Heating ventilation and air conditioning validation Services in nigeria ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation Services in nigeria ,
Validation, Qualification and Calibration ,
Validation tests for hvac system Services in nigeria ,,
Validation Qualification Services in nigeria ,
Qualification and Validation Services in nigeria ,
Compressed Air Validation Services in nigeria ,
Nitrogen Gas Testing or Validation Services in nigeria ,
Pure steam Quality test Validation Services in nigeria ,
Documentation services Validation Services in nigeria ,
Equipment validation Services in nigeria ,
Facilities validation Services in nigeria ,
HVAC system validation Services in nigeria ,
Cleaning validation Services in nigeria ,
process Validation Services in nigeria ,
Analytical method validation Services in nigeria ,
Computer system validation Services in nigeria ,
Packaging validation Services in nigeria ,
Cold chain validation Services in nigeria ,
compressed Air Validation Services in nigeria ,
HVAC Validation Services in nigeria ,
Clean Room Validation Services in nigeria ,
cold chain Validation Services in nigeria ,
PLC Validation Services in nigeria ,
Thermal Validation Services in nigeria ,
Steam Quality Test Services in nigeria ,
Design validation Services in nigeria ,
Pharma Validation Services in nigeria ,
Data verification validation Services in nigeria ,
Clean Room AHU Area Validation Services in nigeria ,
Calibration validation Services in nigeria ,
Equipment Validation Services in nigeria ,
Flow Calibration Validation Services in nigeria ,
IAQ Indoor Air Quality Validation Services in nigeria ,
Equipment validation Services in nigeria ,
Facilities validation Services in nigeria ,
HVAC system validation Services in nigeria ,
Cleaning validation Services in nigeria ,
Process Validation Services in nigeria ,
Analytical method validation Services in nigeria ,
Computer system validation Services in nigeria ,
Design qualification (DQ) Services in nigeria ,
Component qualification (CQ) Services in nigeria ,
Installation qualification (IQ) Services in nigeria ,
Operational qualification (OQ) Services in nigeria ,
Performance qualification (PQ) Services in nigeria ,
Pharmaceutical Process Validation Services in nigeria ,
Prospective Validation Services in nigeria ,
Concurrent Validation Services in nigeria ,
Retrospective Validation Services in nigeria ,
Revalidation Periodic and After Change validation Services in nigeria ,
Compressed Air Validation Services in nigeria ,
HVAC Validation Services in nigeria ,
Clean Room Validation Services in nigeria ,
PLC Validation Services in nigeria ,
thermal validation Services in nigeria ,
Steam Quality Test Services in nigeria,
design validation Services in nigeria ,
pharmaceutical validation Services in nigeria ,
data verification validation Services in nigeria ,
Clean Room AHU Area Validation Services in nigeria ,
Calibration validation Services in nigeria ,
Equipment Validation Services in nigeria ,
IAQ Indoor Air Quality Validation Services in nigeria ,
IAQ Indoor Air Quality Validation Services in nigeria ...
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
Abia
Aba
Arochukwu
Umuahia
Adamawa
Jimeta
Mubi
Numan
Yola
Akwa Ibom
Ikot Abasi
Ikot Ekpene
Oron
Uyo
Anambra
Awka
Onitsha
Bauchi
Azare
Bauchi
Jama′are
Katagum
Misau
Bayelsa
Brass
Benue
Makurdi
Borno
Biu
Dikwa
Maiduguri
Cross River
Calabar
Ogoja
Delta
Asaba
Burutu
Koko
Sapele
Ughelli
Warri
Ebonyi
Abakaliki
Edo
Benin City
Ekiti
Ado-Ekiti
Effon-Alaiye
Ikere-Ekiti
Enugu
Enugu
Nsukka
Federal Capital Territory (Federal Territory)
Abuja
Gombe
Deba Habe
Gombe
Kumo
Imo
Owerri
Jigawa
Birnin Kudu
Dutse
Gumel
Hadejia
Kazaure
Kaduna
Jemaa
Kaduna
Zaria
Kano
Kano
Katsina
Daura
Katsina
Kebbi
Argungu
Birnin Kebbi
Gwandu
Yelwa
Kogi
Idah
Kabba
Lokoja
Okene
Kwara
Ilorin
Jebba
Lafiagi
Offa
Pategi
Lagos
Badagry
Epe
Ikeja
Ikorodu
Lagos
Mushin
Shomolu
Nasarawa
Keffi
Lafia
Nasarawa
Niger
Agaie
Baro
Bida
Kontagora
Lapai
Minna
Suleja
Ogun
Abeokuta
Ijebu-Ode
Ilaro
Shagamu
Ondo
Akure
Ikare
Oka-Akoko
Ondo
Owo
Osun
Ede
Ikire
Ikirun
Ila
Ile-Ife
Ilesha
Ilobu
Inisa
Iwo
Oshogbo
Oyo
Ibadan
Iseyin
Ogbomosho
Oyo
Saki
Plateau
Bukuru
Jos
Vom
Wase
Rivers
Bonny
Degema
Okrika
Port Harcourt
Sokoto
Sokoto
Taraba
Ibi
Jalingo
Muri
Yobe
Damaturu
Nguru
Zamfara
Gusau
Kaura Namoda
Abia
Aba
Arochukwu
Umuahia
Adamawa
Jimeta
Mubi
Numan
Yola
Akwa Ibom
Ikot Abasi
Ikot Ekpene
Oron
Uyo
Anambra
Awka
Onitsha
Bauchi
Azare
Bauchi
Jama′are
Katagum
Misau
Bayelsa
Brass
Benue
Makurdi
Borno
Biu
Dikwa
Maiduguri
Cross River
Calabar
Ogoja
Delta
Asaba
Burutu
Koko
Sapele
Ughelli
Warri
Ebonyi
Abakaliki
Edo
Benin City
Ekiti
Ado-Ekiti
Effon-Alaiye
Ikere-Ekiti
Enugu
Enugu
Nsukka
Federal Capital Territory (Federal Territory)
Abuja
Gombe
Deba Habe
Gombe
Kumo
Imo
Owerri
Jigawa
Birnin Kudu
Dutse
Gumel
Hadejia
Kazaure
Kaduna
Jemaa
Kaduna
Zaria
Kano
Kano
Katsina
Daura
Katsina
Kebbi
Argungu
Birnin Kebbi
Gwandu
Yelwa
Kogi
Idah
Kabba
Lokoja
Okene
Kwara
Ilorin
Jebba
Lafiagi
Offa
Pategi
Lagos
Badagry
Epe
Ikeja
Ikorodu
Lagos
Mushin
Shomolu
Nasarawa
Keffi
Lafia
Nasarawa
Niger
Agaie
Baro
Bida
Kontagora
Lapai
Minna
Suleja
Ogun
Abeokuta
Ijebu-Ode
Ilaro
Shagamu
Ondo
Akure
Ikare
Oka-Akoko
Ondo
Owo
Osun
Ede
Ikire
Ikirun
Ila
Ile-Ife
Ilesha
Ilobu
Inisa
Iwo
Oshogbo
Oyo
Ibadan
Iseyin
Ogbomosho
Oyo
Saki
Plateau
Bukuru
Jos
Vom
Wase
Rivers
Bonny
Degema
Okrika
Port Harcourt
Sokoto
Sokoto
Taraba
Ibi
Jalingo
Muri
Yobe
Damaturu
Nguru
Zamfara
Gusau
Kaura Namoda
list of our services following city and State
Lagos |
Kano |
Ibadan |
Benin City |
Port Harcourt |
Jos |
Ilorin |
Abuja |
Kaduna |
Enugu |
Zaria |
Warri |
Ikorodu |
Maiduguri |
Aba |
Ife |
Bauchi |
Akure |
Abeokuta |
Oyo |
Uyo |
Sokoto |
Owerri |
Yola |
Calabar |
Umuahia |
Ondo City |
Minna |
Lafia |
Okene |
Katsina |
Ikeja |
Nsukka |
Ado Ekiti |
Awka |
Ogbomosho |
Iseyin |
Mubi |
Onitsha |
Sagamu |
Makurdi |
Mokwa |
Badagry |
Ilesa |
Gombe |
Obafemi Owode |
Owo |
Jimeta |
Suleja |
Lavun |
Potiskum |
Kukawa |
Gusau |
Iwo |
Bida |
Ugep |
Ijebu Ode |
Epe |
Ise Ekiti |
Gboko |
Ilawe Ekiti |
Ikare |
Osogbo |
Okpoko |
Garki |
Sapele |
Ila |
Shaki |
Ijero |
Ikot Ekpene |
Jalingo |
Otukpo |
Okigwe |
Kisi |
Buguma |
Funtua |
Abakaliki |
Asaba |
Gbongan |
Igboho |
Gashua |
Bama |
Uromi |
Lagos |
Kano |
Oyo |
Edo |
Rivers |
Plateau |
Kwara |
FCT |
Kaduna |
Enugu |
Kaduna |
Delta |
Lagos |
Borno |
Abia |
Osun |
Bauchi |
Ondo |
Ogun |
Oyo |
Akwa Ibom |
Sokoto |
Imo |
Adamawa |
Cross River |
Abia |
Ondo |
Niger |
Nasarawa |
Kogi |
Katsina |
Lagos |
Enugu |
Ekiti |
Anambra |
Oyo |
Oyo |
Adamawa |
Anambra |
Ogun |
Benue |
Niger |
Lagos |
Osun |
Gombe |
Ogun |
Ondo |
Adamawa |
Niger |
Niger |
Yobe |
Borno |
Zamfara |
Osun |
Niger |
Cross River |
Ogun |
Lagos |
Ekiti |
Benue |
Ekiti |
Ondo |
Osun |
Anambra |
Jigawa |
Delta |
Osun |
Oyo |
Ekiti |
Akwa Ibom |
Taraba |
Benue |
Imo |
Oyo |
Rivers |
Katsina |
Ebonyi |
Delta |
Osun |
Oyo |
Yobe |
Borno |
Edo ...
list of our services following urban Areas
Lagos |
Onitsha |
Kano |
Ibadan |
Uyo |
Port Harcourt |
Nsukka |
Abuja |
Benin City |
Aba |
Kaduna |
Ilorin |
Jos |
Maiduguri |
Owerri |
Ikorodu |
Zaria |
Enugu |
Warri |
Osogbo |
Akure |
Sokoto |
Abeokuta |
Bauchi |
Lagos |
Anambra |
Kano |
Oyo |
Akwa Ibom |
Rivers |
Enugu |
FCT |
Edo |
Abia |
Kaduna |
Kwara |
Plateau |
Borno |
Imo |
Lagos |
Kaduna |
Enugu |
Delta |
Osun |
Ondo |
Sokoto |
Ogun |
Bauchi ...