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:
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    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:
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    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 jind , HVAC validation Services in jind , AHU Validation Services in jind , Qualification validation Services in jind , Mep validation Services in jind , Heating ventilation and air conditioning validation Services in jind , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in jind , Validation, Qualification and Calibration , Validation tests for hvac system Services in jind ,, Validation Qualification Services in jind , Qualification and Validation Services in jind , Compressed Air Validation Services in jind , Nitrogen Gas Testing or Validation Services in jind , Pure steam Quality test Validation Services in jind , Documentation services Validation Services in jind , Equipment validation Services in jind , Facilities validation Services in jind , HVAC system validation Services in jind , Cleaning validation Services in jind , process Validation Services in jind , Analytical method validation Services in jind , Computer system validation Services in jind , Packaging validation Services in jind , Cold chain validation Services in jind , compressed Air Validation Services in jind , HVAC Validation Services in jind , Clean Room Validation Services in jind , cold chain Validation Services in jind , PLC Validation Services in jind , Thermal Validation Services in jind , Steam Quality Test Services in jind , Design validation Services in jind , Pharma Validation Services in jind , Data verification validation Services in jind , Clean Room AHU Area Validation Services in jind , Calibration validation Services in jind , Equipment Validation Services in jind , Flow Calibration Validation Services in jind , IAQ Indoor Air Quality Validation Services in jind , Equipment validation Services in jind , Facilities validation Services in jind , HVAC system validation Services in jind , Cleaning validation Services in jind , Process Validation Services in jind , Analytical method validation Services in jind , Computer system validation Services in jind , Design qualification (DQ) Services in jind , Component qualification (CQ) Services in jind , Installation qualification (IQ) Services in jind , Operational qualification (OQ) Services in jind , Performance qualification (PQ) Services in jind , Pharmaceutical Process Validation Services in jind , Prospective Validation Services in jind , Concurrent Validation Services in jind , Retrospective Validation Services in jind , Revalidation Periodic and After Change validation Services in jind , Compressed Air Validation Services in jind , HVAC Validation Services in jind , Clean Room Validation Services in jind , PLC Validation Services in jind , thermal validation Services in jind , Steam Quality Test Services in jind, design validation Services in jind , pharmaceutical validation Services in jind , data verification validation Services in jind , Clean Room AHU Area Validation Services in jind , Calibration validation Services in jind , Equipment Validation Services in jind , IAQ Indoor Air Quality Validation Services in jind , IAQ Indoor Air Quality Validation Services in jind ...
     
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    list of our services following districts
     
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    alipur | chanakya puri | civil lines | defence colony | delhi cantonment | dwarka | gandhi nagar | hauz khas | kalkaji | kanjhawala | kapeshera | karawal nagar | karol bagh | kotwali | mayur vihar | mehrauli | model town | najafgarh | narela | patel nagar | preet vihar | punjabi bagh | rajouri garden | rohini | saket | saraswati vihar | sarita vihar | seelam pur | seema puri | shahdara | vasant vihar | vivek vihar | yamuna vihar | adampur | alewa | ambala | ambala cantonment | assandh | ateli | babain st | badhra | badkhal | badli | badshahpur st | bahadurgarh | bahal st | bahin st | ballabgarh | ballah st | balsamand st | bapoli | barara | barwala | barwala st | bass | bawal | bawani khera | beri | bhattukalan st | bhiwani | bhuna st | bilaspur | bondkalan st | chhachhrauli | dabwali | dadri | dahina st | dayalpur st | dhand st | dharuhera st | dhauj st | ellenabad | faridabad | farrukhnagar | fatehabad | fatehpur pundri | ferozepur jhirka | ganaur | gaunchi st | gharaunda | gohana | goriwala st | guhla | gurgaon | hansi | harsaru st | hassanpur st | hathin | hisar | hodal | indri | ismailabad st | israna | jagadhri | jakhal st | jhajjar | jind | julana | kadipur st | kaithal | kalanaur | kalanwali | kalayat | kalka | kanina | karnal | khanpur st | kharkhoda | kheri jalab st | khizrabad st | kosli | kulan st | ladwa | lakhan majra st | loharu | maham | mahendragarh | manesar | manethi st | matenhail | matlauda | mohna st | morni st | mulana st | nagina st | nahar st | nangal chawdhary | naraingarh | narnaul | narnaund | narwana | nathusari chopta | nigdu st | nilokheri | nising st | nuh | palhawas st | palwal | panchkula | panipat | pataudi | pehowa | pillukhera st | punahana | radaur | raipur rani | rai st | rajaund st | rania | ratia | rewari | rohtak | sadhaura st | safidon | saha st | salhawas st | samalkha | sampla | saraswati nagar st | satnali st | shahbad | shahzadpur st | sirsa | siwani | siwan st | sohna | sonipat | taoru | thanesar | tigaon st | tohana | tosham | uchana | uklana st | wazirabad st | abohar | ahmedgarh | ajnala | amloh | amritsar -i | amritsar- ii | anandpur sahib | baba bakala | bagha purana | balachaur | banga | barnala | bassi pathana | batala | bathinda | bhawanigarh | bhikhiwind | bhulath | budhlada | chamkaur sahib | dasua | dera baba nanak | dera bassi | dharamkot | dhar kalan | dhuri | dinanagar | dirba | dudhan sadhan | faridkot | fatehgarh sahib | fazilka | firozpur | garhshankar | gidderbaha | gurdaspur | guruharsahai | hoshiarpur | jagraon | jaitu | jalalabad | jalandhar - i | jalandhar - ii | kalanaur | kapurthala | khadur sahib | khamanon | khanna | kharar | kotakpura | lehra | ludhiana (east) | ludhiana (west) | majitha | malerkotla | malout | mamdot | mansa | maur | moga | moonak | morinda | mukerian | muktsar | nabha | nakodar | nangal | nawanshahr | nihal singhwala | pathankot | patiala | patran | patti | payal | phagwara | phillaur | raikot | rajpura | rampura phul | rup nagar | samana | samrala | sangrur | sardulgarh | sas nagar (mohali) | shahkot | sultanpur lodhi | sunam | talwandi sabo | tapa | tarn taran | zira...
     
    list of our services following districts
     
    alampur amb | ani | arki | aut | baddi | bagachnogi | baijnath | baldwara | balh | bali chowki | bangana | banjar | baroh | barsar | bhadrota | bhalai | bharari | bharmour | bharwain | bhattiyat | bhawarna | bhoranj | bhota | bhuntar | bilaspur sadar | birhu kalan | chachyot | chadiyar | chamba | chaupal | chhatri | chirgaon | churah | dadahu | dadasiba | dalhousie | dareeni | darlaghat | deha | dehar | dera gopipur | dhami | dharmpur | dharmsala | dharwala | dhatwal | dhira | dodra kwar | dulahar | fatehpur | gagret | galore | gangath | ghanari | ghumarwin | hamirpur | hangrang | harchakian | haripur | haripurdhar | haroli | holi | indora | ispur | jaisinghpur | jalog | jangla | jaswan | jawalamukhi | jawali | jhanduta | jogindarnagar | jol | jubbal | junga | kakira | kalol | kalpa | kamrau | kandaghat | kangoo | kangra | karsog | kasauli | katoula | khundian | kotgarh | kotkhai | kotla | kotli | krishangarh | kullu | kumarsain | kunihar | kupvi | lad bharol | lagru | lahul | majheen | makridi | mamlig | manali | mandap | mandi | mehatpur | morang | multhan | nadaun | nagrota bagwan | nagrota surian | nahan | naina devi | nalagarh | namhol | nankhari | narag | nerwa | nichar | nihri | nirmand | nither | nohra | nurpur | pachhad | padhar | pajhota | palampur | panchrukhi | pangi | pangna | panjehra | paonta sahib | poo | pragpur | pukhri | rajgarh | rakkar | rampur | ramshahr | renuka | rewalsar | rohru | ronhat | sainj | saluni | sandhol | sangla | sarahan | sarawati nagar | sarkaghat | shahpur | shalai | shimla ( rural ) | shimla (urban) | sihunta | solan | spiti | sulah | sundarnagar | sunni | taklech | tapri | tauni devi bamson | theog | thunag | thural | tihra | tikar | tikken | tira sujanpur | udaipur | una | ajas | akhnoor | aloosa | anantnag | anantnag east | aripal | arnas | arnia | assar | atholi (paddar) | awantipora | bahu | balakote | bandipora | bani | banihal | baramulla | barbugh | bari brahamana | basantgarh | basohli | batote | beerwah | beri pattan | bhaderwah | bhagwah | bhalessa | bhalla | bhalwal | bharath bagla | bhomag | bijbehara | billawar | bishnah | bk pora | boniyar | bounjwah | budgam | chadoora | channapora | charar- e- shrief | chassana | chenani | chhatroo | chilly pingal | chiralla | chitragam | chowki choura | dachhan | dangarpora | danghiwacha | dansal | darhal | devsar | d h pora | dinga amb | doda | dooru | drabshalla | drugmulla | eidgah | frisal | ganderbal | ghagwal | gool | gund | gundna | gurez | hajin | handwara | haveli | hermain | hiranagar | jjind | jjind north | jjind south | jjind west | jourian | kahara | kakapora | kalakote | kangan | karnah | kashtigarh | kathua | katra | kawarhama | keegam | keller | keran | khag | khansahib | khanyar | kharah balli | khari | khawas | khoie | khour | kishtwar | kokernag | koteranka | kralpora | kreeri | kulgam | kunzar | kupwara | lalpora | langate | lar | larnoo | laroka | latti | lohai malhar | lolab | machail | machil | magam | mahanpur | mahore | maira mandrian | majalta | mandal | mandi | manjakote | mankote | marh | marheen | marmat | marwah | mendhar | mohalla | moungri | mughalmaidan | nagri | nagrota | nagseni | narbal | nowshera | pahalgam | pahloo | pampore | panchari | panthachowk | pargwal | pattan | phigsoo | pogal paristan | pouni | pulwama | qaimoh | qaziabad | qazigund | qila darhal | rafiabad | rajgarh | rajouri | rajpora | rajpura | ramban | ramgarh | ramhal | ramkote | ramnagar | ranbir singh pura | reasi | sallar | samba | shahbad bala | shahoora | shangus | shopian | siot | sonawari | sopore | srigufwara | srinagar central | srinagar (north) | srinagar (south) | suchetgarh | sundarbani | surankote | tangmarg | taryath | thakrakote | thana mandi | thathri | thuroo | tral | trehgam | tulail | tullamulla khirbhawani | udhampur | uri | vijaypur | wagoora | wakoora | warwan | watergam | yaripora | zachaldara | zainapora | zaingeer | 277 chandigarh | adibadri | almora | bageshwar | bagwalipokhar | bajpur | balganga | bangapani | barakot | barnigad | basukedar | berinag | betalghat | bhagwanpur | bhanoli | bhatwari | bhikiasain | bironkhal | chakisain | chakrata | chamoli | champawat | chaubatta khal | chaukhutiya | chinyali saur | dehradun | devalthal | devprayag | dewal | dhanaulti | dharchula | dhari | dhaulchhina | dhauntari | dhoomakot | dhyari | didihat | doiwala | dugnakuri | dunda | dwarahat | gadarpur | gairsain | gaja | ganai gangoli | gangolihat | garud | ghaat | ghansali | haldwani | hardwar | jainti | jakhani dhar | jakhanikhal | jakholi | jalali | jaspur | jilasu | joshimath | joshiyara | kafligair | kaladhungi | kalsi | kanalichhina | kanda | kandisaur | kapkot | karnaprayag | kashipur | khatima | kichha | kirtinagar | kosya kutauli | kotdwara | laksar | laldhang | lalkuan | lamgada | lansdowne | lohaghat | machhor | madannegi | manch | mori | munsiari | nainbag | nainital | nanakmatta | nandprayag | narayanbagar | narendra nagar | narsan | okhalkanda | pankhu | pati | pauri | pawkidevi | pithoragarh | pokhari | poornagiri | pratapnagar | pulla gumdesh | puraula | rajgarhi | ramgarh | ramnagar | ranikhet | rikhanikhal | rishikesh | roorkee | rudraprayag | rudrapur | sankari | satpuli | shama | sitarganj | someshwar | srinagar | sult | syalde | tehri | tejam | thailisain | thal | tharali | tyuni | ukhimath | vikas nagar | yamkeshwar | drass | kargil | khalsi | leh | nubra | sanku | shaker chiktan | zanskar...