Biological Indicator (BI), D & Z Value Studies & BioBurden

With one of the world's largest Biological Indicator Evaluation Resistometer (BIER) vessels, Honeyman is one of the only independent contract laboratories with the capability to perform D-Value and Z-Value analysis and other associated thermal studies by direct inoculation of product or equipment using Biological Indicator Organisms (BI's).

Independent, before-use checks of the Biological Indicators are required to ensure that they have not been damaged or compromised during transport, handling or storage, en route from the manufacturer.

Specialists in the validation of sterilisation processes, Honeyman offer the following independent services utilising a wide range of Biological Indicator (BI) formats including; spore ampoules, strips, discs, metal discs, suspensions, threads and wires:

  • Independant D-Value verification of Manufacturer's Certificate Values to ensure no significant differences in accordance with USP and ISO11138 acceptance criteria
  • Z-Value analysis applying EP/PhEur
  • Survival and kill time verification applying either the EP/PhEur or USP Acceptance Criteria
  • Biological Indicator Stability Studies
  • Biological Indicator use and application for the Validation of Sterile Processes
  • Biologcial Indicator Direct Inoculation studies on products, components (e.g. bung or stopper washing sterilisation) and critical equipment
  • Biological Indicator identification
  • Biological Indicator spore counts

For clients with specific requirements we are also able to custom manufacture BI ampoule holders for use in fluid load sterilisation validation. These units ensure that both the BI and the thermocouple are securely located at the slow-to-heat point in the liquid.

Bioburden Analysis

Honeyman Analytical offers a complete Bioburden Analysis services to quantify and identify the microbial Bioburden of components (including, vials, ampoules, stoppers and tubes), equipment and removable machine parts prior to sterilisation.

For more information and for a quotation please contact us.

Why Honeyman?

  • Established History in purity water and steam systems.
  • We can operate on a 'one stop shop' basis, or supply packages of work to suit.
  • From engineering design to installation management, we cover a wide range of skills.