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ISO 17025-2023 Accreditation Certificate
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.
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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.
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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.
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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.
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PBC-TH28-CE_Declaration_of_conformity
PBC-TH28 is able to perform both temperature and humidity calibration or verifications of 28 x PyroButton data-loggers in parallel.
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OpHumGen-CE_Declaration_of_conformity
Opulus Humidity Generator (OpHumGen) maintains a given relative humidity for calibration of PyroButton data loggers with PBC-TH28 calibrator.
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OPAC-CE_Declaration_of_conformity
Opulus Air Compressor (OPAC) work together with the Opulus PBC-TH28 Calibrator. All functions of the OPAC are controlled by the PBC-TH28 measurement program.
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OWC-CE_Declaration_of_conformity
Opulus Water Chiller (OWC) can be used for operating the Opulus PBC-TH28 calibrator below 0°C.
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PBC-TH18-CE_Declaration_of_conformity
PBC-TH18 for combined temperature or humidity calibration/verification of 18 x PyroButtons in parallel.
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PyroRef-T3-CE_Declaration_of_conformity
PyroRef-T/3 is a hardware module interfaced to the PBC-TH18 via the OpCal cable for the use of 3 x OpRef-T in parallel for temperature calibration and verification of the PBC-TH18 calibration instrument.
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iPBX-Net-4-CE_Declaration_of_conformity
iPBX-Net-4 is an intelligent USB high speed docking station with automatic recognition of PBX positions. Suitable for parallel programming /data-download for 4 PyroButtons and PyroButtons-X family.
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iPBX-Net-28-CE_Declaration_of_conformity
iPBX-Net-28 is an intelligent USB high speed docking station with automatic recognition of PBX positions. Suitable for parallel programming /data-download for 28 PyroButtons and PyroButtons-X family.
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iPBX-Net-60-CE_Declaration_of_conformity
iPBX-Net-60 is an intelligent USB high speed docking station with automatic recognition of PBX positions. Suitable for parallel programming /data-download for 60 PyroButtons and PyroButtons-X family.
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SPN-N8O-CE_Declaration_of_conformity
SPB-N8O are multi-PyroButton logger reader docking stations for the synchronized parallel programming or data-download of 8 PyroButtons.
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SPN-N16C-CE_Declaration_of_conformity
SPB-N16C are multi-PyroButton logger reader docking stations for the synchronized parallel programming or data-download of 16 PyroButtons.
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SPN-N50C-CE_Declaration_of_conformity
SPB-N50C are multi-PyroButton logger reader docking stations for the synchronized parallel programming or data-download of 50 PyroButtons.
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PBX-CE_Declaration_of_conformity
PyroButton-X is a new generation of advanced, sustainable and environmentally friendly, self-powered, high-performance, calibrated temperature & humidity data-logger platform with 21 CFR Part 11 compatibility for the measurements of temperature, humidity, pressure and Ethylene Oxide.
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PyroButton SQL - Opulus Database Manager v2.3
User manual
Tutorial
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PyroButton-X - Efficient & Cost Effective Solution for Self-powered Temperature & Humidity & Pressure Mapping, Validation, Monitoring and Documentation
PBX User Manuals: PBXi-TH
PBXi-L
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PyroButton Catalog
Short description and price list of PyroButton product family
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PyroButton-X vs. Competitors - Comparison Chart
The document shows the differences between PyroButton-X and the competitor's data-loggers
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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
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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
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Process Validation for the Manufacture of Human and Animal Drug and Biological Products
FDA Guidance for Process Validation: General Principles and Practices
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Temperature/Humidity Tracking of Facilities
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Meteorological Monitoring of Temperature & Humidity
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PyroButton-X Solution Products for Temperature/Humidity Tracking of Transportation
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PyroButton-X Calibration Management
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Validation Management of Temperature and/or Humidity and/or Pressure
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PyroButton-X Sterilization Process Management
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PyroButton-X Solution Products for Stability Process Management
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PyroButton-X Solution Products for Hygroscopicity Measurements
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