Pharmaceutical Microbiology Bioburden Testing Services

Reduce your medical device and pharma QC lab workload and focus on critical activities

Discover our bioburden testing services portfolio for the Milliflex Oasis® family and Milliflex® Quantum system

Microbiological monitoring and testing in the pharmaceutical industry is a highly regulated and complex field. With our long history of serving the pharmaceutical industry, we have pioneered and refined ground-breaking solutions, demonstrating the regulatory and technological expertise to make compliance as simple as possible, and help save your valuable resources.

With our best-in-class services you can:

  • Optimize your QC lab workflow and ensure regulatory compliance
  • Rely on comprehensive and ready-to-use validation packages
  • Ensure the performance of your Milliflex® pump and Milliflex® Quantum system while reducing the risk of breakdown

BioM Pharma services – Environmental monitoring visual - system life cycle

 

Milliflex Oasis® method development services

Milliflex Oasis® Filtration SystemOptimize or simplify your bioburden testing method using the Milliflex Oasis® pump and Milliflex® Quantum system for easy validation and cost-effective testing.

Your benefits:

  • A name you know
  • People you can trust
  • Methods you can validate
  • Ready when you need us

Method development

Experimental study is carried out in our application laboratory using your samples and microbial strain(s). It is recommended in the case of compatibility issues with the standard protocol or for new products. We develop an appropriate method to overcome any interferences or improve filterability.

Method development consultancy

Our consultancy service is carried out by one of our application scientists to support your method development. It is recommended in the case of compatibility issues with standard protocols or for new products. Our consultancy includes a 1-day on-site training session covering pump use and appropriate method development, a customized test plan, on-site tests with your products, and scheduled weekly follow-up calls.

Besides our method development services we also offer feasibility studies and on-site evaluations for Milliflex® Quantum. Thus you can verify the suitability of the platform before investing.

Milliflex Oasis® validation services

Get ready to start any PQ work in less than 5 days!

Your benefits:

  • Proven protocols and expertise to qualify your system & related consumables
  • Streamlined method validation process
  • Reduced development time and validation costs
  • Maintenance of the qualified status of your system over its lifetime

Validation protocols

Our validation protocols are based on our internal product qualification test methods. These extensive protocols will enable your QC/QA lab to quickly initiate your validation master plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease. The bioburden validation protocols follow international guidelines such as EP/USP and GMP.

On-site IQ/OQ service

Support for the qualification of laboratory equipment:

  • Execution of the test methods
  • Supply of calibrated tools (flow meter, stopwatch, etc.)
  • IQ/OQ section of the final report is completed, ready for QA approval
  • Essential operator training

Essential PQ consultancy service

Consulting service for microbiological validation to plan and initiate the PQ:

  • On-site support for implementation of the PQ tests
  • Consumables and media calculation
  • Training on recovery test techniques
  • Data formatting and report finalization
  • Scheduling of the tests
  • Data interpretation, comments and conclusion

Advanced PQ consultancy service1

Close coaching all along the PQ of the consumable and test method:

  • Presentation of the equipment, accessories and consumables
  • Regulation overview
  • Hands-on training
  • Setting up the lab, equipment, consumables
  • Test campaign – Supervision of the microbiological tests (several days):
    1. The validation engineer demonstrates the test process with the first microorganism.
    2. The technician(s) repeat what has been demonstrated using further replicates and microorganisms.
    3. Result reading and interpretation.

Essential requalification service2

Requalification work performed on laboratory equipment after the yearly preventive maintenance:

  • Requalification protocol to be ordered separately
  • IQ and OQ test procedures (physical tests) + data formatting and report finalization
  • Supply of calibrated tools (flow meter, stopwatch, etc.)

Advanced requalification service2

Requalification work and consulting service for laboratory equipment:

  • Requalification protocol to be ordered separately
  • SOP review
  • Maintenance review
  • IQ and OQ test procedures (physical tests) + data formatting and report finalization
  • Supply of calibrated tools (flow meter, stopwatch, etc.)
  • Operators training review
  • OOS results review

Milliflex Oasis® maintenance services on-site or at repair center

Rely on your Milliflex Oasis® pump or Milliflex® Quantum system and minimize the breakdown risk

Your benefits:

  • Ensure optimum performance and reliability of your system
  • Increase the lifetime of your system
  • Comprehensive documentation for auditability

Preventive maintenance and repair coverage

We offer a variety of maintenance services that can be executed either in our local repair center or at customer site (where available). Preventive maintenance and pump verification ensure efficient operation of critical testing equipment. Every system should be serviced regularly to ensure its performance remains compliant with the specifications. We recommend checking and adjusting the system on an annual basis as well as after repair service.

  • Preventive maintenance including as found and as left tests
  • Maintenance kits
  • Repair coverage
  • Genuine spare parts
  • Performance report
  • Rush fee optional

End of life verification

We can verify your equipment in our local repair center or at your site. At the end of the service you receive a performance report including as found data of your equipment. Recommended before decommissioning your Milliflex Oasis® pump  or Milliflex® Quantum system.

Milliflex Oasis® training services

Ensure your lab team can get the best out of your Milliflex Oasis® pump or Millflex® Quantum rapid detection system

  • Benefit from decades of expertise
  • Certify your lab staff
  • Avoid common handling issues
  • Get familiar with good microbial limit testing practices

Milliflex® school3

Theoretical aspects of bioburden testing:

  • Regulatory aspect of bioburden testing (raw material, in process, final product release, water testing)
  • Critical needs for filtration method
  • How to ensure reliable results (avoid false positive and negative results)
  • Introduction to rapid technologies and Milliflex® Quantum System

Interactive workshop:

  • Review of all Milliflex Oasis® features (funnels, agar, hardware) and how to make the best choice for your bioburden testing
  • Demo of Milliflex Oasis® pump and review of the best practices for routine use and daily maintenance
  • Demo of Milliflex® Quantum system

Milliflex® advanced operator training3

This course Includes the theoretical aspects and interactive workshop in addition to a hands-on session on the best practices of use of the Milliflex® and/or Milliflex® Quantum platform. A training certificate is delivered to each participant after evaluation.

BEST and on-site BEST microbiology training4

BEST is a 3-day innovative, interactive educational program designed specifically for you. This program will focus on both in-process and product release quality control, including bioburden, endotoxin, and sterility testing, and environmental monitoring. The training will provide an overview of relevant methods in each area; however, basic technical laboratory skills are assumed as a prerequisite for participation. The course will consist of class presentations and demonstrations of laboratory applications.

  • Understand the current requirements of pharmacopoeias and be familiar with good testing procedures from method development / validation through to routine test result interpretation
  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize testing procedures
  • Understand and identify root causes for common issues
  • Hands-on training

Learn more about our BEST QC Microbiology Training

1 Available for Milliflex® pump only

2 Available for Milliflex® pump in Western Europe only

3 Not available in North America

4 Available in North America only