Microbiological Laboratory & Validation Services

Microbiological Laboratory & Validation Services

Validate UV Processes. Verify Microbial Reduction. Reduce Development Risk.

Developing a new UV-C or Pulsed Light application? Hoenle supports manufacturers with customized microbiological testing and industrial validation services. From feasibility studies to validation under real process conditions, we help you verify the effectiveness of your disinfection process with reliable, reproducible results.

Customer Benefits

Reliable validation is essential for developing safe and effective UV processes. Our microbiological laboratory provides customized testing services that help verify performance, accelerate product development and support process optimization.

Customized Testing

Reliable Results

Industrial Validation

Our Validation Services

Instead of standard test methods, we develop customized validation protocols that reflect your real production environment and application.

UV Bioindicators
  • Development and use of patented UV bioindicators (2–6 log)
  • Fast and reliable evaluation of UV systems
  • Suitable for low pressure, medium pressure, UV-LED and pulsed light
Effect of UV Treatment on Food Shelf Life
  • Before vs. after UV treatment comparisons
  • Validation of hygiene improvements without compromising quality
  • Support for safer and longer-lasting food products
Material Migration Testing
  • Global and specific migration analysis
  • Comparison before and after UV treatment
  • Ensuring material safety and regulatory compliance
Customized UV Treatments
  • UV protocols adapted to your real process conditions
  • Validation under realistic operating parameters
  • Direct transfer from lab results to industrial application
Neo-Formed Compounds & Organoleptic Testing
  • Analysis of neo-formed compounds after UV exposure
  • Organoleptic tests (taste, odor, appearance) in cooperation with qualified partners
  • Ensuring UV effectiveness without negative sensory impact

Technologies

Our laboratory supports validation of a wide range of UV technologies.

  • Low Pressure UV
  • Medium Pressure UV
  • Pulsed Light
  • UV LED
analysing microbiological indicators

Tested Matrices

Our validation services are performed on a wide variety of products and materials, including:

  • Food Products
  • Packaging Materials
  • Powders (Spices & Seeds)
  • Pharmaceutical Liquids
  • Cosmetic Products
  • Industrial Surfaces
  • …and more

Hermetic UV Biological Indicators

Reliable Process Qualification

Hoenle’s hermetic UV biological indicators are specifically developed for validating UV disinfection processes. They provide reproducible, secure and easy-to-use verification of microbiological performance during process qualification.

Key Benefits

  • Hermetically sealed
  • Easy to handle
  • Highly reproducible
  • Safe to use
  • Designed for process validation
Bioindicators for measurement of log reduction, hermetically sealed spores easy to use for operators and authorities

Industries

Our microbiological validation services support customers across numerous industries.

  • Food & Beverage
  • Pharmaceutical
  • Cosmetics
  • Packaging
  • Medical Devices
  • Industrial Manufacturing
  • … and more

FAQs

Why should UV processes be microbiologically validated?

Microbiological validation verifies that your UV or Pulsed Light process achieves the required microbial reduction under real operating conditions. It provides reliable data for process optimization, quality assurance and regulatory requirements.

Which microbial strains are used in Sterixene bioindicators?

Sterixene bioindicators contain standardized, non-pathogenic microbial strains for validation and monitoring purposes. Commonly used strains from the DSMZ (German Collection of Microorganisms and Cell Cultures) include:

  • Aspergillus brasiliensis – DSM 1988

  • Aspergillus niger – DSM 737

  • Aspergillus carbonarius – DSM 872

  • Bacillus atrophaeus – DSM 7264

  • Bacillus subtilis – DSM 23778

  • Geobacillus stearothermophilus – DSM 5934

  • Bacillus pumilus – DSM 27

  • Penicillium rubens – DSM 1075

How long are the bioindicators usable after receipt?

The shelf life of the bioindicators depends on the microbial strain:

Microorganism Usable life after receipt
Aspergillus brasiliensis DSM 1988 1 month
Aspergillus niger DSM 737/DSM1957 1 month
Aspergillus carbonarius DSM872 1 month
Bacillus atrophaeus DSM675/DSM 7264 6 months
Bacillus subtilis DSM23778 6 months
Geobacillus stearothermophilus DSM5934 6 months
Bacillus pumilus DSM27 6 months
Penicillium rubens DSM1075 3 weeks

Are the microbial tests safe to handle?

Yes. All strains used in Sterixene bioindicators are non-pathogenic and widely recognized for safe use in sterility testing and process validation. Standard laboratory safety procedures should always be followed.

Are the results reliable?

Yes, reference samples are stored at Sterixene in refrigerators until their expiration date. Each shipment includes three comparison indicators to ensure stability during transport.

How long does it take to prepare a microbial report?

The processing time depends on the scope of the analysis. As a rule, we provide reports within 2–5 business days.

Can Hoenle develop customized validation protocols?

Yes. Every application is different. Our microbiologists develop customized test protocols tailored to your products, microorganisms, process conditions and validation objectives to deliver meaningful and reproducible results.

Which products and materials can be tested?

We perform microbiological testing on a wide range of matrices, including food products, packaging materials, powders such as spices and seeds, pharmaceutical and cosmetic liquids, as well as industrial surfaces. If your application is not listed, our team will be happy to evaluate it.

Contact And Support

Ready to Validate Your UV Process? Our microbiology experts are happy to discuss your application and develop a customized validation strategy.

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