Project Description

  • Biological/Chemical Indicator Evaluation Resistometer(BIER)
  • Biological/Chemical Indicator Evaluation Resistometer(BIER)
  • Biological/Chemical Indicator Evaluation Resistometer(BIER)

Biological/Chemical Indicator Evaluation Resistometer(BIER)

The BIER (Biological Indicator Evaluator Resistometer) system is designed to provide reproducible reference environmental conditions for evaluating the resistance of microbial populations to steam sterilization, H2O2 plasma sterilization or EO sterilization. The BIER test system incorporates a dynamic air removal system with a leak detection system to verify that air is removed from the test system. The evacuation is followed by a rapid pressurization with steam or vaporized hydrogen peroxide or EO gas to the pre-selected sterilization temperature or pressure.

Sterilization deals with the destruction of microorganisms by exposing materials to conditions that are rapidly lethal to them. The validation of these processes generally relies on the use of resistant microorganisms termed biological indicators (BIs) that are positioned within the sterilizer. The destruction of these microorganisms during validation confirms the lethality of the process for the routine use of the sterilizer. Routine sterilization must be sufficiently lethal to the bioburden expected on or in the materials being processed. Information about the process resistance of both the BI and bioburden is essential to understanding process effectiveness. Over- or under-estimating the resistance of either the indicator or the indigenous bioburden can lead to failed validation studies, potentially contaminated batches, sterility failure investigations, and other serious situations.

What’s BIER vessels?

Medical and pharmaceutical technologists developed BIER vessels around conventional autoclave technology. The autoclave is a steam-pressure vessel in which materials are placed into a chamber at ambient pressure. The door is closed, steam is admitted into the chamber, and steady-state conditions are achieved. With specially engineered systems using very small chambers, the system can achieve nearly instantaneous come-up and cool-down conditions.

These special sterilizers were almost exclusively custom designed.

The BIER vessel establishes a steady-state condition within a small sterilization chamber and relies on the rapid insertion and removal of samples for the conduct of the D-value determination.

Why BIER Vessels?

The majority of BIER vessels use extremely small chambers for various reasons:

  • Small chambers are all that are required to evaluate limited numbers of spore strips and inoculated components products.
  • A small chamber is more easily brought to and from the desired sterilizing conditions. (An adjacent larger chamber is sometimes used as a reservoir for the sterilizing medium.)
  • Smaller chambers are easier to maintain uniformly within the desired conditions.

Pressure Steam Sterilization Evaluation Resistometer

Pressure Steam Sterilization Evaluation Resistometer

Suitable for resistance testing of pressure steam sterilization biological indicators, chemical indicators, and BD indicators.

Technical parameters:

  • Capacity: 5L
  • Rated pressure: 0.21Mpa
  • Max pressure: 0.25Mpa
  • Max temperature: 140℃
  • Rated temperature: 105~134 ℃
  • The time for the inlet steam to heat up to the set temperature≤10s
  • Draining time≤5s
  • Vacuum degree<-97KPa
  • Power: 9KW
  • Overall size(L*W*H): 700*780*1700mm
  • Weight: 200kg

Hydrogen Peroxide Sterilization Evaluation Resistometer

Suitable for resistance testing of hydrogen peroxide sterilization biological indicators, chemical indicators.

Technical parameters:

  • Vacuum pressure (before H2O2 injection): 80pa ±5pa
  • Working temperature: 50℃±0.5℃
  • When working, the H2O2 concentration is 2.7±0.3mg/L, and the working temperature is displayed in real time.
  • There is a diffusion vaporization chamber (large chamber volume 135L) and a sterilization testing chamber (small chamber volume 1.5L), both of which have electric lift doors.
  • There are hydrogen peroxide injection devices and vaporization devices
  • Power:6KW
  • Overall size(L*W*H): 900*1100*1700mm
  • Weight: 300kg

Ethylene Oxide Gas Sterilization Evaluation Resistometer

Ethylene Oxide Gas Sterilization Evaluation Resistometer

Suitable for resistance testing of ethylene oxide sterilization biological indicators, chemical indicators.

Technical parameters:

  • Vacuum pressure (before EO injection): -95KPa
  • Working temperature: 54℃±1℃
  • When working, the EO concentration is 600±30mg/L, and the working concentration is displayed in real time.
  • There is a diffusion vaporization chamber (large chamber volume 100L) and a sterilization testing chamber (small chamber volume 1.5L), both of which have electric lift doors.
  • There are EO injection devices and pre-heat devices
  • Automatically controlled humidification device and humidity sensor, the humidity is controlled at 60%±10%
  • Power: 6KW
  • Overall size(L*W*H): 800*1020*1680mm
  • Weight: 180kg