STB ValiTech – Calibration, instrument setup and process qualifications

Instrument setup and process qualifications

stb valitechSTB SYS Automation

 


STB Valitech  is a company, which specializes in providing services towards to sectors of health Care Science by the industry regulations (cGMP, FDA, GAMP and ISO).
Our staff has many years of Experience in the validation of industrial plants and equipment used in chemical, biotechnological and pharmaceutical processes and in the process of the heat sterilization (wet and dry) depyrogenation and lyophilization.

STB ValiTech manages follows: 

  • Writing VMP VP and metrological Plans;
  • Drafting of the technical specifications (User and Functional),management procedures, functional and operational Preparation of Impact Assessment and Risk Analysis. With Scientific instruments owned and regularly calibrated and certified by the main recognized (LAT, SIT, EA).

Preparation and executing protocols of:

  • Qualification (IQ, OQ e PQ)
  • Re qualification and periodic check qualification
  • Revision and drafting of Validation Reports/final Summary conclusions.
  • Smoke map test “At-Rest” and “Operational”

STB Valitech  offers a customized service of validation for all the kind of computerized systems:
information management systems, production area system and applications used in laboratories.

STB Valitech  has a large experience in Pharma, Chemical, Petrochemical, Food, Textiles, Electronics, Energy and Mechanical sectors.

It is able to perform calibrations of electronic and pneumatic instrumentation for industrial plants using sample instruments certified LAT or EA recognized and following STB ValiTech procedures and/or customers’ procedures.

Our industrial service consist of:

  • Calibration and instruments verification;
  • Maintenance of electrical and instrumental components
  • Supply and installation of process instruments.

 

esecuzione test di validazione in camere-bianche

Clean-room validation test

Esecuzione test per la verifica della direzionalità dei flussi

Air flow pattern test

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