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Last modified: 2018-01-18 
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Minimal configuration of PyroButton Self-powered data-logger system:

 - PyroButton Self-powered data-logger
 - PyroButton adapter
 - PyroButton software
 
Warranty period:
Calibrated data-loggers - 1 years warranty (Opulus Licensee is required)
 
 Download Catalog
Valid to: 2018-12-31
 


PyroButton data-logger packages
Product Code Description Price
List price:
100-PKE-005-100 Sterilization Process Management - Steam/Basic Package
A 21 CFR Part 11 compliant System.
Includes:
(1) 4 x PyroButton-T - Self-powered temperature device (0 to 125°C; see, option for PyroButton-E of 15 to 140°C),
Temperature resolution ±0.0625°C, Temperature accuracy ±0.2°C.
Calibrated at 5-points relative to NIST reference or equivalent International Reference.
Each measurement is corrected relative to the calibration curve.
(2) SPB-N16C Smart Docking Station with USB adapter for the parallel programming & data-download of 16 PyroButtons (see, option for SPB-N50C docking station for 50 PyroButtons).
(3) PyroButton-SQL/S v3.18 software with 21 CFR Part 11 compliance. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express with SPC (includes: Sterilization, Clean Room, Process, Facilities, & Container/Closure application modules; provides heat distribution map, heat penetration evaluation, loading effects, container/closure evaluation, PQ, and much more);
(4) IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols.

1 workstation license (see, Application)
9,275
/package 

package
 
100-PKE-006-100 Sterilization Process Management - ETO/Basic Package
A 21 CFR Part 11 compliant System.
Includes:
(1) 4 x PyroButton-TH - Self-powered temperature/humidity data-logger Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy Calibrated at 5-temperature points relative to NIST reference and 5-humidity points. Each measurement is corrected relative to the calibration curve.
(2) SPB-N16C Smart Docking Station with USB adapter for the parallel programming & data-download of 16 PyroButtons (see, option for SPB-N50C docking station for 50 PyroButtons).
(3) PyroButton-SQL/S v3.18 software with 21 CFR Part 11 compliance. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express with SPC (includes: Sterilization, Clean Room, Process, Facilities, & Container/Closure application modules; provides heat & moisture distribution map, loading effects, container/closure evaluation, PQ, and much more); Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation.
(4) IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols.

1 workstation license (see, Application)
10,356
/package 

package
 
100-PKE-007-100 Packaging Validation Process Management - Basic Package
A 21 CFR Part 11 compliant System.
Includes:
(1) 4 x PyroButton-TH - Self-powered temperature/humidity data-logger Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy Calibrated at 5-temperature points relative to NIST or International reference and 5-humidity points. Each measurement is corrected relative to the calibration curve.
(2) SPB-N16C Smart Docking Station with USB adapter for the parallel programming & data-download of 16 PyroButtons (see, option for SPB-N50C docking station for 50 PyroButtons).
(3) PyroButton-SQL/PV v3.18 software with 21 CFR Part 11 compliance. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express with SPC (includes: Sterilization, Clean Room, Process, Facilities, & Container/Closure application modules; provides heat & moisture distribution map, loading effects, container/closure evaluation, PQ, and much more); Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation.
(4) IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols.

1 workstation license (see, Application)
10,356
/package 

package
 
100-PKE-009-100 Transportation Temperature Management - Basic Package
A 21 CFR Part 11 compliant System.
Includes:
(1) 4 x PyroButton-G - Self-powered temperature device (-40 to +85°C), Temperature resolution ±0.5°C, Temperature accuracy ±0.5°C Calibrated at 5-points relative to NIST or International reference. Each measurement is corrected relative to the calibration curve.
(2) SPB-N8O Smart Docking Station with USB adapter for the parallel programming & data-download of 8 PyroButtons (see, options for SPB-N16C for 16 or SPB-N50C docking station for 50 PyroButtons).
(3) PyroButton-SQL/T-Basic v3.18 software with 21 CFR Part 11 compliance. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express. Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation.

1 workstation license (see, Application)

(4) Option: IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols.
5,500
/package 

package
 
100-PKE-010-100 Transportation Temperature Management - Advanced System for Pharmaceutical, Biotech, & Medical Device
A 21 CFR Part 11 compliant System.
Includes:
(1) 4 x PyroButton-L - Self-powered temperature device (-40 to +85°C), Temperature resolution 0.0625°C, Temperature accuracy ±0.25°C Calibrated at 5-points relative to NIST or International reference. Each measurement is corrected relative to the calibration curve.
(2) SPB-N16C Smart Docking Station with USB adapter for the parallel programming & data-download of 16 PyroButtons (see, option for SPB-N50C docking station for 50 PyroButtons).
(3) PyroButton-SQL/TA v3.18 software with 21 CFR Part 11 compliance. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express with SPC (includes: Sterilization, Clean Room, Process, Facilities, & Container/Closure application modules; provides heat & moisture distribution map, loading effects, container/closure evaluation, PQ, and much more); Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation.
(4) IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols.

1 workstation license (see, Application)
9,063
/package 

package
 

PyroButton Self-powered temperature & humidity data-loggers
Product Code Description Price
List price:
100-IBE-001-100 PyroButton-G
Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature device (-40 to +85°C), Temperature resolution ±0.5°C, Temperature accuracy ±0.5°C Calibrated at 5-points relative to NIST or International reference. Each measurement is corrected relative to the calibration curve. Data integrity protection for 21 CFR Part 11 requirement.
154
/each 

each
100-IBE-003-100 PyroButton-L
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature device (-40 to +85°C); Temperature resolution ±0.0625°C, Temperature accuracy ±0.2°C Calibrated at 5-points relative to NIST reference. Each measurement is corrected relative to the calibration curve. Data integrity protection for 21 CFR Part 11 requirement.
217
/each 

each
100-IBE-004-100 PyroButton-T
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature device (0 to 125°C), Temperature resolution ±0.0625°C, Temperature accuracy ±0.2°C Calibrated at 5-points relative to NIST reference. Each measurement is corrected relative to the calibration curve. Data integrity protection for 21 CFR Part 11 requirement.
292
/each 

each
100-IBE-005-100 PyroButton-TH
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature/humidity data-logger Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy Calibrated at 5-temperature points relative to NIST reference and 5-humidity points. Each measurement is corrected relative to the calibration curve. Data integrity protection for 21 CFR Part 11 requirement.
398
/each 

each
100-IBE-006-100 PyroButton-E
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market. Self-powered temperature device (15 to 140°C), Temperature resolution ±0.0625°C, Temperature accuracy ±0.2°C Calibrated at 5-points relative to NIST reference. Each measurement is corrected relative to the calibration curve. Data integrity protection for 21 CFR Part 11 requirement.
398
/each 

each

PyroButton adapters - programming/data-download
Product Code Description Price
List price:
100-IAE-007-100 SPB-N8O smart docking station with USB Adapter. Suitable for parallel programming / data-download for 8 PyroButtons 795
/each 

each
100-IAE-009-100 SPB-N16C docking station with USB Adapter. Suitable for parallel programming / data-download for 16 PyroButtons 1,431
/each 

each
100-IAE-005-100 SPB-N50C docking station with USB Adapter. Suitable for parallel programming / data-download for 50 PyroButtons 3,578
/each 

each

PyroButton software for Self-powered temperature & humidity monitoring system
Product Code Description Price
List price:
100-PBE-007-020E PyroButton-SQL/Basics v3.18 software with 21 CFR Part 11 compliance
Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express & SPC. Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation.
Optional: IQ-OQ-PQ & 21 CFR Part 11 Verification Protocols
1 workstation license
4,500
/each 

each
100-PBE-007-016 IQ-OQ-PQ verification protocol for PyroButton-SQL/Basic software 1,500
/each 
   
each
100-PBE-007-017 21 CFR Part 11 verification protocol for PyroButton-SQL/Basic software 1,500
/each 
   
each
100-PBE-007-021E PyroButton-SQL/PRO v3.18 software with 21 CFR Part 11 compliance
Windows 7, Windows 8 and Windows 10 (32/64bits) compatible. Includes 2005 MS SQL Express with SPC (includes: Sterilization, Clean Room, Process, Facilities, & Container/Closure application modules; provides heat & moisture distribution map, loading effects, container/closure evaluation, PQ, and much more); Built-in automatic correction of measurement based on the calibration curve. Signal processing program module for optimization of signal smoothing for the reduction of inherent noise of humidity measurements, which improve accuracy, and reproducibility. Built-in uncertainty of measurement calculation. 21 CFR Part 11 compliant 1 workstation license IQ-OQ-PQ verification protocol 21 CFR Part 11 verification protocol are included.
1 workstation license
8,454
/license 

license

Calibrators & Calibration Services
Product Code Description Price
List price:
100-ICE-021-100 PyroButton-TQM with PBC-TH18
A 21 CFR Part 11 ISO 17025 compliant system. Windows 7, Windows 8 and Windows 10 (32/64bits) compatible.

Includes:
(1) Calibration Operating System with Total Quality Management
(2) MS SQL 2005 Express (i.e., network version available)
(3) PyroButton Calibration & Verification Life Cycle Management
(4) PBC-TH18 calibrator’s Calibration & Life Cycle Management
(5) Automatic generation of Calibration Certificates
(6) Integration of multiple Opulus calibrators & calibrator types
(7) CAPA & OOS Management
(8) Integrated Compliance Management
(9) Integrated Material Management

Combined Temperature/Humidity
Calibrator System for simultaneous calibration of 18 PyroButtons (3.4 %RH ... 97.3 %RH & 10°C to 70°C).
Can be integrated to PyroButton softwares for fully automatic correction. (see, Application)
16,785
/each 

each
100-ICE-023-100 PyroCheck-H18
Humidity Verification system for 18 x PyroButton-TH in parallel. Certificate of Verification is generated automatically; integrated Excel compatibility
6,890
/each 

each
100-ICE-031-100 PBC-TH18 calibration service 1,585
/each 

each
100-ICE-034-100 PyroPlate calibration re-service 1,600
/each 

each
100-ICE-001-100A PyroButton data-logger temperature re-calibration with verification
NOTE: If the number of data-loggers are 10 or less add $150 set-up fee
50
/point 

point
100-ICE-001-100B PyroButton data-logger temperature re-calibration
NOTE: If the number of data-loggers are 10 or less add $150 set-up fee
40
/point 

point
100-ICE-001-100C PyroButton data-logger humidity re-calibration with verification
NOTE: If the number of data-loggers are 10 or less add $150 set-up fee
60
/point 

point
100-ICE-003-100A PyroButton data-logger humidity re-calibration
NOTE: If the number of data-loggers are 10 or less add $150 set-up fee
45
/point 

point
 Download Catalog
Valid to: 2018-12-31


Shipping conditions
Standard shipping time: 4-6 weeks.


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