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Sterilizers Thermal Validation 

 [/vc_column_text][vc_single_image image=”945″ img_size=”full” alignment=”center” style=”vc_box_rounded”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Thermal Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process

Thermal Validation System

Our thermal validation software provides compliance with FDA regulation in 21CFR Part 11 

It is  providing a Full Automated Reporting and Report Management , Validation Plan (Acceptance Tests) , File security ,Security operator access control ,Security window password controls ,Audit Trail ,Login Window, Electronic signature and Electronic signature management

In addition, software provides all the essential elements for meaningful and successful validation.

-All parameters including calibration data associated with a validation study are stored in a specific secured, configuration file, printable for hardcopy filing.

-During the test, data is time stamped and stored at a default scan value in an unmodifiable, replayable binary data file.

-Operators can view in real time any or all parameters being measured with both graphical and digital displays.

-Data presentation facilities are configurable prior, during or after test. Remember all data is available for processing from the 1 second time stamped, secure binary data file.

-The configured validation test data can be printed for hardcopy in both graphical and tabular format.

Standards and Regulations

HTM2010. Part 3. Validation and Verification

 

BS EN 554 – Sterilization of Medical Devices. Validation and routine control of moist heat sterilization.

 

ANSI/AAMI/ISO 11135-1:2007 – Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, 4ed[/vc_column_text][vc_hoverbox image=”683″ primary_title=”Steam Sterilizer Autoclave Thermal Validation” primary_title_font_container=”color:%23000000″ hover_title=”Steam Sterilizer Autoclave Validation” hover_background_color=”white” align=”right” use_custom_fonts_primary_title=”true”]

Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process

  • Heat Distribution and Penetration Study
  • Cold and Hot Points Detecting
  • Sterilization Period Calculation ( Min , Max , Sterilization Time )
  • Lethality Calculations

[/vc_hoverbox][/vc_column][/vc_row][vc_row][vc_column][vc_hoverbox image=”1311″ primary_title=”Thermal Validation FOR ETO Sterilizers” primary_title_font_container=”color:%23000000″ hover_title=”Thermal Validation FOR ETO Sterilizers” hover_background_color=”white” align=”right” use_custom_fonts_primary_title=”true”]EtO sterilization is used on heat sensitive products. Consequently validation exercises must verify that temperature remains within specified parameters. Other critical parameters are pressure and humidity.

  • Cycle Physical performance Analysis
  • Temperature and Relative Humidity monitoring
  • Pressure monitoring

[/vc_hoverbox][vc_hoverbox image=”1312″ primary_title=”Depyrogenation Validation” primary_title_font_container=”color:%23000000″ hover_title=”Depyrogenation Validation” hover_background_color=”white” align=”right” use_custom_fonts_primary_title=”true”]Depyrogenation Validation:

The removal of pyrogens from glass and lab equipment in dry heat ovens or Tunnels is called Depyrogenation.

Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels can be achieved within a dry heat sterilizer.

  • Heat Distribution and Penetration Study
  • Cold and Hot Points Detecting
  • Depyrogenation Period Calculation ( Min , Max , Sterilization Time )
  • Lethality Calculations

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