Analytical Services Laboratory  |  Biological Indicators and Chemical Indicators

Honeyman performs D Value and Z Value analysis and a range of thermal studies by direct inoculation of product or inoculation of equipment using Biological Indicators (BI's) and our BIER (Biological Indicator Evaluation Resistometer) Vessel.

Biological Indicators (BI’s) are recommended by the European Pharmacopoeia (section 5.1.3) and required by the United States Pharmacopeia chapter <55>  to challenge and validate production steam autoclave sterilisation cycles.

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

Honeyman also test chemical indicators used in the validation of steam sterilisation processes.

Our BIER vessel has one of the largest chambers in the world (the dimensions are 40cm wide, 40 cm high and 60cm deep), which allows thermal studies to be performed on relatively large equipment parts.

We offer the following independent services:

• Independent D Value Determination – Testing and Retesting Verification of Manufacturer's Certificate Values to Ensure no Significant Differences in Accordance with USP and ISO 11138 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
   

• Biological Indicator Direct Inoculation Studies on Products, Components (e.g. Bung or Stopper Washing Sterilisation) and Critical Equipment
   

• Biological Indicator Identification
   

• Biological Indicator Spore Counts

The above can be performed on a wide range of Biological Indicator (BI) formats e.g. spore ampoules, strips, discs, metal discs, suspensions, threads and wires. Honeyman applies the BI manufacturer's methods or those requested by the client.

As an additional support service we 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.

Honeyman is one of the major independent laboratories in Europe performing D Value analysis providing detailed reports that meet regulatory expectations for the evaluation  and measurement of Biological Indicators.

Honeyman Group Ltd
Harmire Enterprise Park, Barnard Castle, County Durham, DL12 8BN, U.K.
Tel: +44 (0)1833 690101  Fax: +44 (0)1833 690102
Email: enquiries@honeyman.co.uk    www.honeyman.co.uk