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Last modified: 2024-03-18

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Certificates & Documents


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Certificates & Documents

Certificates
Documents

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 (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 (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 (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 (100 KB)

Documents

	PyroButton SQL - Opulus Database Manager v2.3 User manual Pdf file (2 MB) Tutorial 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 (335 KB) PBXi-L Pdf file (375 KB)
	PyroButton Catalog Short description and price list of PyroButton product family 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 (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 (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 (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 (380 KB)
	Temperature/Humidity Tracking of Facilities Pdf file (459 KB)
	Meteorological Monitoring of Temperature & Humidity Pdf file (74 KB)
	PyroButton-X Solution Products for Temperature/Humidity Tracking of Transportation Pdf file (93 KB)
	PyroButton-X Calibration Management Pdf file (366 KB)
	Validation Management of Temperature and/or Humidity and/or Pressure Pdf file (170 KB)
	PyroButton-X Sterilization Process Management Pdf file (146 KB)
	PyroButton-X Solution Products for Stability Process Management Pdf file (469 KB)
	PyroButton-X Solution Products for Hygroscopicity Measurements Pdf file (72 KB)

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