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 ...

THERMAL VALIDATION
 
 
 
* Thermal validation qualification of the following equipments
 
  • validation of international standards as per WHO TRS 961, ISO/IEC:60068, HTM 2010 , regulatory bodies like USFDA, TGA, MHRA, WHO, 21CFR etc.
  • • Autoclave / Sterilizer Qualification
  • • Cold rooms, Warehouse and Room Mapping
  • • Depyrogenation Ovens Qualification
  • • Lyophilizers Qualification
  • • Depyrogenation Tunnels
  • • BOD, Deep Freezers / Walk In Freezers
  • • Photostability Chember Qualification
  • • Steam-in-Place Qualification
  • • Incubators
  • • Stability Cabinets
  • • Washer Disinfectors
  • • CIP Systems
  • • Dry Heat Ovens
  • • Furnaces
  • • SIP Systems
  • • Ultra Low Freezers
  • Autoclave/Terminal Sterilizer (Sterilization process)
  • Sterilizing Tunnels (Depyrogenation Process)
  • Steam In Place (Manufacturing & Holding vessel and fermantors sterilization process)
  • Dry Heat Sterilizer (Dry heat sterilization process)
  • Lyphilizer (Chamber sterilization and Freeze drying process temperature distribution)
  • Bung Washer and Sterilizer
  •  
    STEAM STERILIZATION
     
  • Autoclave
  •  
  • Material
  • Product Sterilization
  • Inline – Filter Sterilization
  •  
  • SIP Processes
  •  
  • Vessels & storage tanks
  • Fermentation lines
  • Stopper sterilization
  • Filling lines
  • Lyophilizers
  • Inline-filter sterilization
  •  
    PROCESS SIMULATION
     
  • Temperature Studies
  •  
  • Heating & cooling processes for material & liquids
  •  
  • Freezing & thawing processes
  •  
  • Liquids in bottles & bags
  • Lyophilizers (product temperatures)
  •  
    DRY HEAT STERILIZATION
     
  • Sterilization Tunnel
  •  
    Sterilization and depyrogenation of vials & ampoules (All loading conditions, cooling zone sterilization)
     
  • Dry Heat Sterilizer
  •  
  • Laboratory / hospital
  • Production equipment
  •  
    TEMPERATURE AND CLIMATE MAPPING
     
  • Temperature Mapping
  •  
  • Freezers, deep & ultra deep
  • Cooling & storage units
  • Liquid nitrogen tanks
  • Lyophilizers (Shelf Mapping)
  •  
  • Climate Mapping
  •  
  • Incubators
  • Climate & stability testing chambers
  • Cleanrooms
  •  
    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 croatia , HVAC Validation Validation in croatia , AHU Validation Validation in croatia , Qualification Validation in croatia , Mep Validation in croatia , Heating ventilation and air conditioning Validation in croatia , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation in croatia , Validation, Qualification and Calibration , Validation tests for hvac system , Validation Qualification Services , Qualification and Validation in croatia , Compressed Air Validation in croatia , Nitrogen Gas Testing or Validation in croatia , Pure steam Quality test Validation in croatia , Documentation services Validation in croatia , Equipment Validation in croatia , Facilities Validation in croatia , HVAC system Validation in croatia , Cleaning Validation in croatia , process Validation in croatia , Analytical method Validation in croatia , Computer system Validation in croatia , Packaging Validation in croatia , Cold chain Validation in croatia , compressed Air Validation in croatia , HVAC Validation in croatia , Clean Room Validation in croatia , cold chain Validation in croatia , PLC Validation in croatia , Thermal Validation in croatia , Steam Quality Test , Design Validation in croatia , Pharma Validation in croatia , Data verification Validation in croatia , Clean Room AHU Area Validation in croatia , Calibration Validation in croatia , Equipment Validation in croatia , Flow Calibration Validation in croatia , IAQ Indoor Air Quality Validation in croatia , Equipment validation, Facilities Validation in croatia , HVAC system Validation in croatia , Cleaning Validation in croatia , Process Validation in croatia , Analytical method Validation in croatia , Computer system Validation in croatia , Design qualification (DQ) , Component qualification (CQ) , Installation qualification (IQ) , Operational qualification (OQ) , Performance qualification (PQ) , Pharmaceutical Process Validation in croatia , Prospective Validation in croatia , Concurrent Validation in croatia , Retrospective Validation in croatia , Revalidation Periodic and After Change Validation in croatia , Compressed Air Validation in croatia , HVAC Validation in croatia , Clean Room Validation in croatia , PLC Validation in croatia , thermal Validation in croatia , Steam Quality Test , design Validation in croatia , pharmaceutical Validation in croatia , data verification Validation in croatia , Clean Room AHU Area Validation in croatia , Calibration Validation in croatia , Equipment Validation in croatia , IAQ Indoor Air Quality Validation in croatia , IAQ Indoor Air Quality Validation in croatia ...
     
    Validation Services List
     
    Clean Room validation Services in croatia , HVAC validation Services in croatia , AHU Validation Services in croatia , Qualification validation Services in croatia , Mep validation Services in croatia , Heating ventilation and air conditioning validation Services in croatia , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in croatia , Validation, Qualification and Calibration , Validation tests for hvac system Services in croatia ,, Validation Qualification Services in croatia , Qualification and Validation Services in croatia , Compressed Air Validation Services in croatia , Nitrogen Gas Testing or Validation Services in croatia , Pure steam Quality test Validation Services in croatia , Documentation services Validation Services in croatia , Equipment validation Services in croatia , Facilities validation Services in croatia , HVAC system validation Services in croatia , Cleaning validation Services in croatia , process Validation Services in croatia , Analytical method validation Services in croatia , Computer system validation Services in croatia , Packaging validation Services in croatia , Cold chain validation Services in croatia , compressed Air Validation Services in croatia , HVAC Validation Services in croatia , Clean Room Validation Services in croatia , cold chain Validation Services in croatia , PLC Validation Services in croatia , Thermal Validation Services in croatia , Steam Quality Test Services in croatia , Design validation Services in croatia , Pharma Validation Services in croatia , Data verification validation Services in croatia , Clean Room AHU Area Validation Services in croatia , Calibration validation Services in croatia , Equipment Validation Services in croatia , Flow Calibration Validation Services in croatia , IAQ Indoor Air Quality Validation Services in croatia , Equipment validation Services in croatia , Facilities validation Services in croatia , HVAC system validation Services in croatia , Cleaning validation Services in croatia , Process Validation Services in croatia , Analytical method validation Services in croatia , Computer system validation Services in croatia , Design qualification (DQ) Services in croatia , Component qualification (CQ) Services in croatia , Installation qualification (IQ) Services in croatia , Operational qualification (OQ) Services in croatia , Performance qualification (PQ) Services in croatia , Pharmaceutical Process Validation Services in croatia , Prospective Validation Services in croatia , Concurrent Validation Services in croatia , Retrospective Validation Services in croatia , Revalidation Periodic and After Change validation Services in croatia , Compressed Air Validation Services in croatia , HVAC Validation Services in croatia , Clean Room Validation Services in croatia , PLC Validation Services in croatia , thermal validation Services in croatia , Steam Quality Test Services in croatia, design validation Services in croatia , pharmaceutical validation Services in croatia , data verification validation Services in croatia , Clean Room AHU Area Validation Services in croatia , Calibration validation Services in croatia , Equipment Validation Services in croatia , IAQ Indoor Air Quality Validation Services in croatia , IAQ Indoor Air Quality Validation Services in croatia ...
     
    list of our services following cities
     
    zagreb | split | rijeka | osijek | zadar | slavonski brod | pula | sesvete | karlovac | varazdin | stenjevec | sibenik | centar | sisak | velika gorica | vinkovci | vukovar | dubrovnik | bjelovar | koprivnica | pozega | solin | zapresic | gjakovo | cakovec | virovitica | samobor | kutina | metkovic | petrinja | zupanja | rovinj | makarska | nova gradiska | krizevci | sinj | knin | slatina | trogir | brezovica | porec | daruvar | cepin | podstrana | ogulin | beli manastir | nasice | labin | valpovo | opatija | umag | drenova | tenja | novska | belisce | crikvenica | kastel stari | ivankovo | visnjevac | omis | kastel novi | gjurgevac | mursko sredisce | vodice | gospic | buzet | ilok | otok | pitomaca | senj | ivanec | jastrebarsko | kastel luksic | darda | biograd na moru | novi vinodolski | gunja | borovo | kastel kambelovac | pazin | krapina | zagreb | split | rijeka | osijek | zadar | velika gorica | slavonski brod | pula | karlovac | sisak | varaždin | šibenik | dubrovnik | bjelovar | kaštela | samobor | vinkovci | koprivnica | ðakovo | vukovar | cakovec | požega | zaprešic | sinj | petrinja | solin | kutina | virovitica | križevci | sveta nedelja | dugo selo | metkovic | porec | našice | sveti ivan zelina | jastrebarsko | knin | omiš | vrbovec | ivanic-grad | rovinj | nova gradiška | ogulin | makarska | ivanec | slatina | novska | umag | novi marof | trogir | gospic | krapina | županja | popovaca | opatija | labin | daruvar | valpovo | pleternica | duga resa | crikvenica | benkovac | belišce | imotski | garešnica | kastav | ploce | beli manastir | otocac | donji miholjac | glina | trilj | zabok | vodice | pazin | ludbreg | pakrac | lepoglava | bakar | ðurdevac | mali lošinj | cazma | rab | prelog | drniš | senj | ozalj | ilok | pregrada | vrgorac | grubišno polje | varaždinske toplice | otok | mursko središce | krk | kutjevo | lipik | oroslavje | buzet | vodnjan | zlatar | delnice | donja stubica | korcula | biograd na moru | orahovica | buje | novi vinodolski | slunj | vrbovsko | kraljevica | novigrad | obrovac | hvar | supetar | pag | skradin | cabar | novalja | opuzen | klanjec | cres | stari grad | hrvatska kostajnica | nin | vrlika | vis | komiža | zagreb | split-dalmatia | primorje-gorski kotar | osijek-baranja | zadar county | zagreb county | brod-posavina | istria county | karlovac county | sisak-moslavina | varaždin county | šibenik-knin | dubrovnik-neretva | bjelovar-bilogora | split-dalmatia | zagreb county | vukovar-srijem | koprivnica-križevci | osijek-baranja | vukovar-srijem | medimurje | požega-slavonia | zagreb county | split-dalmatia | sisak-moslavina | split-dalmatia | sisak-moslavina | virovitica-podravina county | koprivnica-križevci | zagreb county | zagreb county | dubrovnik-neretva | istria county | osijek-baranja | zagreb county | zagreb county | šibenik-knin | split-dalmatia | zagreb county | zagreb county | istria county | brod-posavina | karlovac county | split-dalmatia | varaždin county | virovitica-podravina county | sisak-moslavina | istria county | varaždin county | split-dalmatia | lika-senj | krapina-zagorje | vukovar-srijem | sisak-moslavina | primorje-gorski kotar | istria county | bjelovar-bilogora | osijek-baranja | požega-slavonia | karlovac county | primorje-gorski kotar | zadar county | osijek-baranja | split-dalmatia | bjelovar-bilogora | primorje-gorski kotar | dubrovnik-neretva | osijek-baranja | lika-senj | osijek-baranja | sisak-moslavina | split-dalmatia | krapina-zagorje | šibenik-knin | istria county | varaždin county | požega-slavonia | varaždin county | primorje-gorski kotar | koprivnica-križevci | primorje-gorski kotar | bjelovar-bilogora | primorje-gorski kotar | medimurje | šibenik-knin | lika-senj | karlovac county | vukovar-srijem | krapina-zagorje | split-dalmatia | bjelovar-bilogora | varaždin county | vukovar-srijem | medimurje | primorje-gorski kotar | požega-slavonia | požega-slavonia | krapina-zagorje | istria county | istria county | krapina-zagorje | primorje-gorski kotar | krapina-zagorje | dubrovnik-neretva | zadar county | virovitica-podravina county | istria county | primorje-gorski kotar | karlovac county | primorje-gorski kotar | primorje-gorski kotar | istria county | zadar county | split-dalmatia | split-dalmatia | zadar county | šibenik-knin | primorje-gorski kotar | lika-senj | dubrovnik-neretva | krapina-zagorje | primorje-gorski kotar | split-dalmatia | sisak-moslavina | zadar county | split-dalmatia | split-dalmatia | split-dalmatia ....