ebro Validation-Set for large Steam Sterilizers SL 2100 The Set contains:

Transcription

1 ebro Validation-Set for large Steam Sterilizers SL 2100 The Set contains: 1 x Pressure-Temperature Data Logger EBI 10-TP321 5 x Temperature Data Logger EBI 10-T441 1 x Silicone Protection Box AL x Silicone Protection Box AL x Interface EBI IF x Software Winlog.pro Operating Instructions, Carrying Case Winlog.pro General Software for ebro data loggers Winlog.med Validation Software for routine checks and validation in the medical field Winlog.pharm Software for routine checks and validation in the pharmaceutical industry Winlog.pro The general software for programming and evaluation of ebro data loggers. Graphic and numeric presentation of data process Supports all types of ebro data loggers Wireless online monitoring for loggers with radio communication Formel editor for calculation of A 0 -value, F 0 -value and theoretic steam temperature Statistics of measuring data (e.g. average value, standard deviation, MKT, MIN/MAX) Data file and system audit trail 21 CFR Part 11 compliant Winlog.med An evaluation software for data loggers, specifically designed for cleaning and sterilization processes in central sterilization departments. Most process flows during daily routine checks and during the annual validation are handled automatically. Winlog.med Easy to use software for programming, evaluation, calibration and report generation. Very user-friendly Automatic evaluation of all measured data Display and print out of all temperature and pressure curves in all phases Mapping: sensor placement captured in three dimensional definition Automatic generation of reports Unambiguous results (passed / failed) Evaluation according to EN 285, 554, DIN , EN Winlog.pharm Is a powerful reporting and evaluation tool designed to meet the tough requirements of pharmaceutical validation, qualification and measurement tasks. The software combines a user-friendly interface with intuitive report generation to make your job easier. Winlog.pharm Easy to use software for programming, evaluation, calibration and report generation. User-friendly software interface and report generation tools User-defined validation templates possible Cycle detective for steam sterilization Automatic report generation Mapping: sensor placement captured in three dimensional definition Supported by: SOP, IQ/OQ and Validation Reference documentation package 21 CFR Part 11 compliant WE have the solutions to meet YOUR validation and measurement requirements! Use ebro systems to validate: Sterilizers / Dry heat ovens / Warehouses / Cold rooms and freezers / Refrigerators / Incubators / Transport / Shipping studies...

2 Industry Pharmacy Chemistry Medicine Food : A new Generation of Data Loggers from ebro New: Wireless Realtime Monitoring in High-Temperature Processes Bulletin E

3 Product Range EBI 10-T100 EBI 10-T101 EBI 10-T210/T211 Data Logger Family General technical specifications: (Apply to all models) Channels Temperature: Pt 1000 Pressure (opt.): piezo-resistive (temperature compensated) Resolution Temperature: C (0.045ºF) Pressure (opt.) 1 mbar Sampling Rate 1s h Memory measured values Measuring Mode Endless mode Measure upon start time Measure upon start temperature Start immediately until end of memory Start / stop time Communication Wireless 2.4 GHz / IEEE Eyelet Optional, provided with every type of EBI 10 Operating Temperature -4 Battery 3.6 V, field-replaceable Size Ø 46 mm x 24 mm * Weight 70 g * Material Stainless steel (V4A) / PEEK Protection class IP 68 / NEMA 6P *Size and weight are shown for EBI 10 body only in washing machines, heating tunnels, temperature chambers, washer disinfectors -4 ±0.1 C (0 C C) For transport of blood, blood plasma and organs, as well as for pharmaceutical products and validation of freeze dryers: for low temperatures down to -85 C (-121 F) -85 C C (-121 F F) ±0.5 C (-85 C C) ±0.2 C (-40 C C) ±0.9 F(-121 F F) ±0.4 F (-40 F F) in the food industry, F, C value calculation in autoclaves and food retorts -4 ±0.1 C (0 C C) > The EBI 10 wireless data logger monitors even hot processes (i.e. 134 C / 273 F in steam sterilization) in realtime > The user can follow the process live on the monitor > Faulty processes can be recognized immediately and stopped if necessary, saving time and effort. internal internal external, radial EBI 10-T210: Ø 3 mm / L=50 mm EBI 10-T211: Ø 3 mm / L=75 mm Applications: Monitoring of sterilization in pharmaceutical and medical industries Routine checks and validation in hospitals F-value calculation in the food industry Bottle cleaning, temperature measurement in the beverage industry Description EBI 10-T EBI 10-T

4 EBI 10-T23X EBI 10-T26X/ T36X EBI 10- T220/T221 EBI 10-T240/ T241 EBI 10-T441 EBI 10-TP200 EBI 10-TP230 Bottle Logger (M10 thread) in the food industry, F, C value calculation in autoclaves and food retorts Wireless measurements in the beverage industry for core temperature and therefore of PU-value; 1-(only PU) and 2-(PU and spray temperature) channel version available in washer disinfectors and autoclaves (validation), especially for measurements in small trays. In combination with EBI-TIB for measuring in dry heat sterilizers and furnaces, probe length 250 mm and 500 mm. Probe bendable to reach inaccessible places. Validation of washer disinfectors, autoclaves and SIP systems, probe length 500 mm. Probes bendable to reach inaccessible places. Validation of washer disinfectors and autoclaves measurements. Hose, flange and glass coupling available. Rinsing pressure in washer disinfectors measurements. Logger especially for routine checks in autoclaves -4 ±0.1 C (0 C C) EBI 10-T230: Ø 3 mm / L=50 mm EBI 10-T231: Ø 3 mm / L=75 mm EBI 10-T232: Ø 3 mm / L=100 mm EBI 10-T233: Ø 3 mm / L=150 mm -4 26X: 36X: 2 temperatures, external/internal, axial -40 C C* (-40 F F) * For measurements over 150 C (302 F) EBI-TIB must been used ±0.1 C () ±0.5 C (+150 C C) ±0.2 F (32 F F) ±0.9 F (302 F F) external, radial EBI 10-T220: Ø 1.5 mm / L=250 mm EBI 10-T221: -4 EBI 10-T240: Ø 1.5 mm / L=250 mm EBI 10-T241: -4 2 temperature, Ø 1.5 mm /L = 500 mm Ø 3 mm / L=40 mm M 10 inner thread Ø 3 mm / L=40 mm Description EBI 10-T EBI 10-T EBI 10-T EBI 10-T Description EBI 10-T EBI 10-T EBI 10-T EBI 10-T Description EBI 10-T EBI 10-T Description EBI 10-T EBI 10-T

5 Logger Accessories EBI 10-TP231 EBI 10-TP221 EBI 10-TP321 EBI 10-TP421 EBI IF 100 AL 100 Single interface for EBI 10 (as well as for EBI 11) Silicone protection box for EBI 10 (temperature) measurements. In washer disinfectors, for measuring of the temperature and rinsing pressure, especially with Luerlock connector measurements, logger especially for validation of autoclaves and washer/disinfectors measurements. Logger especially for validation of autoclaves and washer/disinfectors measurements. Logger especially for validation of autoclaves and washer/disinfectors USB connection Colored LED signals status (program, read out, error) Includes additional external antenna for autoclave applications Works with: Winlog.pro Winlog.med Winlog.med. validation Winlog.pharm heat spikes mechanical damage Enhances lifetime of logger EBI IF 200 AL 101 Ø 3 mm / L=40 mm 2 temperature, 3 temperature, 4 port interface for EBI 10 USB connection Colored LED signals status (program, read out, error) Includes additional external antenna for autoclave applications Works with: Winlog.pro Winlog.med Winlog.med. validation Winlog.pharm EBI TIB Silicone protection box for EBI 10 (temperature and pressure) heat spikes mechanical damage Enhances lifetime of logger Thermal insulation box for R-loggers. Stainless steel, 160 x 160 x 82 cm Description EBI IF EBI IF EBI TIB Description AL AL

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