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Last modified: 2024-07-23 
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Certificates

  • ISO 17025-2018 Accreditation Certificate8
    This document certifies that the PyroGroup Calibration Laboratory complies with criteria of Standard ISO/IEC 17025:2018. Expiry date of the accredited status: July 27, 2028.
    Pdf file Pdf file (451 KB)

  • Certificate of Temperature Calibration Sample of PyroButton-X Data-logger
    PyroButton-X Calibrations comply with ISO/IEC 17025:2018 and 21 CFR Part 11 of Electronic Records; Electronic Signatures. All measurements and tests are traceable to NIST or International Reference Standard.
    Pdf file Pdf file (11 KB)

  • Certificate of Humidity Calibration Sample of PyroButton-X Data-logger
    PyroButton-X Calibrations comply with ISO/IEC 17025:2018 and 21 CFR Part 11 of Electronic Records; Electronic Signatures. All measurements and tests are traceable to NIST or International Reference Standard.
    Pdf file Pdf file (11 KB)

  • Certificate of Pressure Calibration Sample of PyroButton-X Data-logger
    PyroButton-X Calibrations comply with ISO/IEC 17025:2018 and 21 CFR Part 11 of Electronic Records; Electronic Signatures. All measurements and tests are traceable to NIST or International Reference Standard.
    Pdf file Pdf file (100 KB)


    Documents

  • PyroButton SQL - Opulus Database Manager v2.3
    User manual Pdf file Pdf file (2 MB)  Tutorial  file file (3 MB)

  • PyroButton-X - Efficient & Cost Effective Solution for Self-powered Temperature & Humidity & Pressure Mapping, Validation, Monitoring and Documentation
    PBX User Manuals: PBXi-TH Pdf file Pdf file (335 KB)  PBXi-L Pdf file Pdf file (375 KB) 

  • PyroButton Catalog
    Short description and price list of PyroButton product family
    Pdf file Pdf file (596 KB)

  • PyroButton-X vs. Competitors - Comparison Chart
    The document shows the differences between PyroButton-X and the competitor's data-loggers
     file file (20 KB)

  • PyroButton-X Data-loggers Specifications - Comparison Chart
    The document compares the available PyroButton-X data-loggers and helps to choose the most suitable data-logger for the specific employment
     file file (14 KB)

  • Sterilization Process Validation in Applications for Human and Veterinary Drug Products
    FDA Guidance for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
    Pdf file Pdf file (58 KB)

  • Process Validation for the Manufacture of Human and Animal Drug and Biological Products
    FDA Guidance for Process Validation: General Principles and Practices
    Pdf file Pdf file (380 KB)

  • Temperature/Humidity Tracking of Facilities
    Pdf file Pdf file (459 KB)

  • Meteorological Monitoring of Temperature & Humidity
    Pdf file Pdf file (74 KB)

  • PyroButton-X Solution Products for Temperature/Humidity Tracking of Transportation
    Pdf file Pdf file (93 KB)

  • PyroButton-X Calibration Management
    Pdf file Pdf file (366 KB)

  • Validation Management of Temperature and/or Humidity and/or Pressure
    Pdf file Pdf file (170 KB)

  • PyroButton-X Sterilization Process Management
    Pdf file Pdf file (146 KB)

  • PyroButton-X Solution Products for Stability Process Management
    Pdf file Pdf file (469 KB)

  • PyroButton-X Solution Products for Hygroscopicity Measurements
    Pdf file Pdf file (72 KB)





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