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 ...

STEAM QUALITY TEST
 
 
 
Steam Quality Test Validation
 
  • qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with cGMP (Orange Guide), HTM 01, HTM 2010: 1994, HTM 2031: 1997, EN 285: 2006, AAMI ST79, ISO 14937:2000, ISPE Baseline Guide for Steam and Water and PDA Technical Reports No. 1 & 48.
  •  
  • 1) Non-condensible gases.
  • 2) Super-heated Steam.
  • 3) Dryness Value Test.
  •  
    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
     
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    Validation Services List
     
    Clean Room validation Services in tenkasi , HVAC validation Services in tenkasi , AHU Validation Services in tenkasi , Qualification validation Services in tenkasi , Mep validation Services in tenkasi , Heating ventilation and air conditioning validation Services in tenkasi , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in tenkasi , Validation, Qualification and Calibration , Validation tests for hvac system Services in tenkasi ,, Validation Qualification Services in tenkasi , Qualification and Validation Services in tenkasi , Compressed Air Validation Services in tenkasi , Nitrogen Gas Testing or Validation Services in tenkasi , Pure steam Quality test Validation Services in tenkasi , Documentation services Validation Services in tenkasi , Equipment validation Services in tenkasi , Facilities validation Services in tenkasi , HVAC system validation Services in tenkasi , Cleaning validation Services in tenkasi , process Validation Services in tenkasi , Analytical method validation Services in tenkasi , Computer system validation Services in tenkasi , Packaging validation Services in tenkasi , Cold chain validation Services in tenkasi , compressed Air Validation Services in tenkasi , HVAC Validation Services in tenkasi , Clean Room Validation Services in tenkasi , cold chain Validation Services in tenkasi , PLC Validation Services in tenkasi , Thermal Validation Services in tenkasi , Steam Quality Test Services in tenkasi , Design validation Services in tenkasi , Pharma Validation Services in tenkasi , Data verification validation Services in tenkasi , Clean Room AHU Area Validation Services in tenkasi , Calibration validation Services in tenkasi , Equipment Validation Services in tenkasi , Flow Calibration Validation Services in tenkasi , IAQ Indoor Air Quality Validation Services in tenkasi , Equipment validation Services in tenkasi , Facilities validation Services in tenkasi , HVAC system validation Services in tenkasi , Cleaning validation Services in tenkasi , Process Validation Services in tenkasi , Analytical method validation Services in tenkasi , Computer system validation Services in tenkasi , Design qualification (DQ) Services in tenkasi , Component qualification (CQ) Services in tenkasi , Installation qualification (IQ) Services in tenkasi , Operational qualification (OQ) Services in tenkasi , Performance qualification (PQ) Services in tenkasi , Pharmaceutical Process Validation Services in tenkasi , Prospective Validation Services in tenkasi , Concurrent Validation Services in tenkasi , Retrospective Validation Services in tenkasi , Revalidation Periodic and After Change validation Services in tenkasi , Compressed Air Validation Services in tenkasi , HVAC Validation Services in tenkasi , Clean Room Validation Services in tenkasi , PLC Validation Services in tenkasi , thermal validation Services in tenkasi , Steam Quality Test Services in tenkasi, design validation Services in tenkasi , pharmaceutical validation Services in tenkasi , data verification validation Services in tenkasi , Clean Room AHU Area Validation Services in tenkasi , Calibration validation Services in tenkasi , Equipment Validation Services in tenkasi , IAQ Indoor Air Quality Validation Services in tenkasi , IAQ Indoor Air Quality Validation Services in tenkasi ...
     
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    list of our services following states
     
    andaman and nicobar islands | andhra pradesh | arunachal pradesh | assam | bihar | chandigarh | chhattisgarh | delhi | goa | gujarat | haryana | himachal pradesh | jtenkasi and kashmir | jharkhand | karnataka | kerala | ladakh | lakshadweep | madhya pradesh | maharashtra | manipur | meghalaya | mizoram | nagaland | odisha | puducherry | punjab | rajasthan | sikkim | tamil nadu | telangana | the dadra and nagar haveli and daman and diu | tripura | uttarakhand | uttar pradesh | west bengal ...
     
    list of our services following districts
     
    afzalpur | ajjampura | aland | alnavar | alur | anekal | ankola | annigeri | arkalgud | arsikere | athni | aurad | babaleshwar | badami | bagalkot | bagepalli | bailahongala | bainduru | ballari | bangarapet | bantval | basavakalyan | basavana bagevadi | belagavi | beltangadi | belur | bengaluru east | bengaluru north | bengaluru south | bhadravati | bhalki | bhatkal | bidar | bilgi | brahmavara | byadgi | chadachan | challakere | chamarajanagar | channagiri | channapatna | channarayapatna | chikkaballapura | chikkamagaluru | chiknayakanhalli | chikodi | chincholi | chintamani | chitaguppa | chitradurga | chittapur | dandeli | davanagere | devadurga | devanahalli | devara hipparagi | dharwad | dodda ballapur | gadag | gajendragad | gangawati | gauribidanur | gokak | gubbi | gudibanda | guledgudda | gundlupet | gurumitkal | hadagalli | hagaribommanahalli | haliyal | hangal | hanur | harapanahalli | harihar | hassan | haveri | hebri | heggadadevankote | hirekerur | hiriyur | 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