Bioburden Determination

Bioburden testing is performed by Lucideon to ensure that your products comply with the associated standards. Lucideon offers assessment of the quality of your production processes and can work with clients to produce solutions and improvements.

Bioburden testing is used in a number of situations as part of:

  • validation and revalidation of sterilization processes
  • routine monitoring for control of manufacturing processes
  • assessment of the efficiency of cleaning processes

Bioburden testing is required by regulatory authorities for Investigational New Drug (IND) submission. It allows you to quantify viable microorganisms on or in your pharmaceutical product or packaging.

We offer:

  • extraction and enumeration methods in accordance with Ph. Eur/USP
  • fast turnaround times

Bioburden testing can indicate potential problems such as inadequate sterilization and quality issues in the manufacturing process. The outcome of bioburden testing can help with calculating effective sterilization doses and help QC in sterilization procedures.

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Resources

  • White paper

    Additive Manufacturing - A Metallurgical Perspective

    pdf 4 MB

  • Newsletter

    Pharmaceutical Newsletter

    pdf 418 KB

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