Biological indicator resistance meter

1. Basic characteristics

The FedegariBIER biological indicator resistance tester is a device used to identify biological indicators (BI), which can be used to verify or determine the D value (thermal resistance value) and z value (temperature coefficient).

This device can be used for various liquid or solid biological indicators. During the normal sterilization process, the high-pressure sterilizer removes the biological indicator without causing any obstruction to the sterilization chamber.

Main features of the equipment:

Cost-effective

Multi functional can be used as a sterilizer or resistance tester

Function:

Easy to use;

Fast testing speed

Complies with existing international norms and guidelines:

EN866-3： 1999: Biological systems used for testing sterilizers and sterilization processes. Special system for wet steam sterilizers.

ISO/CD11138-3： Sterilization of healthcare products - Biological indicators - Part 3: Biological indicators for wet heat sterilization process.

ANSI/AAMIST44： 2002: Resistance tester used to characterize the performance of biological and chemical indicators.

Biological indicator resistance meter

2. Operation

The equipment can only introduce BI into the sterilization chamber when the set temperature is reached and stabilized.

The operator can initiate the loading sequence in the BI chamber using automatic software running in the process controller or PLC (controller). The load sequence includes the pressure balance between the load chamber of the equipment and the sterilizer chamber, as well as the load of BI in the sterilizer chamber.

After the set time, the controller will automatically activate some valves that discharge condensed water, and then unload BI into the cold bath to quickly stop the heating process and avoid hot tails.

This solution makes the preheating and preheating time of BI very short, thus meeting the requirements of EN866-3 and ANSI/AMIST44:2002 specifications

3. Components and Safety

The manufacturing of the equipment complies with safety regulations,

It is made of omnidirectional valves with many pneumatic actuators equipped with controllers.

The software of the controller controls the opening/closing sequence of valves for the operator in a completely safe manner and achieves complete repeatability of the process.

All valves and pipelines are made of stainless steel.

Both entering and unloading areas comply with safety regulations

4. Accessories and Options

Theequipmentincludes:

Temperature probe bracket

Two test tubes for loading solid or liquid biological indicator tubes

5. Options

Optional accessories available:

Stainless steel test tube with screw cap for liquid biological indicator (BI), with a capacity of 3ml.

The micro temperature probe is fixed on the BI test tube to read the permeation rate of heat in the suspension.

Containers for collecting biological indicators after processing.

6. Reference for some major users

FoodandDrugAdministration（FDA）-NationalCenterforFoodSafetyandTechnology-6502S.ArcherRd.Summit-Argo,IL60501

SGMBiotech,Inc.-10EvergreenDrive,SuiteEBozeman,MT59715USA

PDAGlobalHeadquarters-BethesdaTowers-4350EastWestHighway,Suite200Bethesda,MD20814USA.