MK Teknology1 Private Limited
MK Teknology1 Private Limited
New Delhi, Delhi
GST No. 07AAFCM2477F1ZG
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Validation Services

  • 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 Pharmaceuticals industries there are several validations which are carried out frequently like Compressed Air Validation, HVAC Validation, Process Validation, Pure Steam Validation, Nitrogen Gas Validation, Thermal Validation, Cleaning Validation, Equipment Validation, PLC Validation and many more.
mk teknology1 is an ISO 9001:2015 Certified Organization. Our strengths are our experienced, work dedicated, versatile staff and sophisticated instruments with calibration certificates from NABL accredited laboratories. mk teknology1 is serving the field of Pharma Industries from last 13 years. Our Key services which we offered to different pharmaceutical industries across PAN INDIA & OVERSEAS.

Pure Steam Testing

Pure Steam Testing
  • Pure Steam Testing
  • Pure Steam Testing
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Steam that is generally produced by a Pure Steam Generator and whose condensed shall meet the requirements of WFI. Pure Steam is used in much area in pharmaceuticals industries such as sterilizing tanks, Autoclave, filters and piping systems, as well as products in sterilizers. Moreover, it is used for air-moistening in clean room systems. 

Steam Testing is required for following reasons: 

To check the quality of steam.To qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with HTM 01-01, HTM 2010 & EN 285.To satisfy your Regulator/QA immediately.

mk teknology1 carried all the tests which are mandatory to check for quality of Pure Steam. All the tests, testing methods along with standard guidelines are mention below:

A) Type of Tests – Non condensable gas Test, Dryness Test & Super Heat Test.
B) Testing Method – Physical Tests
C) Guidelines References - HTM 01-01, HTM 2010, EN 285.  
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Compressed Air & Nitrogen Gas Testing

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Compressed Air is a form of stored energy that is used to operate machinery, equipment or processes. Compressed Air & Nitrogen gas Testing is simply a standardized test that can be used to analyse the quality of air &      detect any kind of contamination present in it. A Sterile enviourment is essential in the pharmaceuticals industries. Any contaminates in the compressed air & Nitrogen gas such as Oil, Moisture and Solid Matter can cause process disruptions, production shutdown & expensive product recalls.  So manufacturing units can take no chances, demanding the high quality of air at all the times without any question. 

mk teknology1 has understood the importance of product risks by monitoring the air against quality standards, testing, giving accurate results and advising the risk factor to the clients.Mk teknology1 carried all the tests which are mandatory to check for quality of air & Nitrogen Gas. All the tests, testing methods along with standard guidelines are mention below:  

A) Type of Tests – Non Viable Particle count test , Dew point Test, Oil Mil Test, Moisture Test , Oxygen Test, Carbon Dioxide Test, Carbon Monoxide Test , Sulphur Dioxide Test , Nitrogen Oxide+ Dioxide Test ,Viable Test, Hydrocarbon Test , Solid Particulate Matter & Odour Test.

B) Testing Method – Laser Particle Counting, Condensation Method, Thimble Method, Gas Analyser, Detector Tubes, Gas Chromatography, Oxygen Analyser.

C) Guidelines References - ISO 8573, USP, EP, BP, ISO 14644, EU-GMP.
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Temperature Testing

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Temperature Mapping is performed to determine if a storage area can maintain temperature within in define limit (Fridges, Freezers, Rooms, Ware house & Incubators etc). Sensors are distributed throughout the unit /room in pre define location to confirm it perform within pre- defined set points. The storage area is further challenged with additional test such as empty mapping, loaded mapping, door open, power failure, fan failure etc. Which are all performed to demonstrate the unit controls within pre- defined parameters & to determine the positions of permanent monitoring /alarm probes. 
mk teknology1 carried all the tests which are mandatory to do temperature mapping. All the tests, testing methods along with standard guidelines are mention below:

A) Type of Testing – Storage Area testing, Rooms & Equipments.
B) Testing Method – Test Function methodology (Data monitoring).
C) Guidelines References - WHO (TRS-961), EU-GMP.  
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Sanjay Miglani (Director)
MK Teknology1 Private Limited
GG-1, 139-C, PVR Road, Vikaspuri
New Delhi - 110001, Delhi, India



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