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Pharma Microbiology Method Validation

Proven Protocols and Expertise to Qualify our Products for Use in Your Testing Processes

cGMPs/cGLPs require equipment and test method to be validated before routine use. This can be time consuming and delay the start of critical QC procedures. Receive prepared protocols and have your new QC systems validated quickly and efficiently by our experts and save time with this process.

Reduce the Development Time & Cost of the Validation

Your protocol preparation may require around 4 weeks of development (research on applicable regulations, acceptance criteria definition, test method writing, formatting, etc).

Estimated IQ/OQ completion time:

  • Without pre-written protocol: 6 to 7 weeks
  • With our pre-written protocol: 2 to 3 weeks
  • With on-site validation service: less than a week
  • Quickly integrate equipment into your process pipeline with confidence using product specific test methods

Rely on Our Comprehensive Validation Package either On-Site or Remote

We have experienced and trained validation engineers who are skilled to assist in Validation Protocol implementation within the QC microbiology laboratory, so your QC/QA departments do not have to allocate resources. Technical training on your installed equipment is also provided during the validation engineer’s visit. In order to maintain regulatory compliance over time we recommend performing a periodic requalification of your pump.

On-Site Essential PQ Consultancy Service

Support for the implementation of microbiological tests (PQ) of the validation protocol:

  • Detailed and complete presentations of microbiological test up to date with regulations
  • On-site support for implementation of tests
  • Tips and tricks to optimize time and quantity of consumables for the PQ
  • On-site data analysis support and report generation
  • Continued support over phone and email
  • Duration: 0,5 day

*Available for Steritest™, Steritest™ Symbio, Milliflex®, Milliflex Oasis®, Milliflex® Quantum, MAS-100 NT®, MAS-100 VF, RCS High Flow Touch

On-Site Advanced PQ Consultancy Service

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

  • Presentation of the equipment, accessories and consumable
  • Regulation overview
  • Hands-on training
  • Setting up the lab, equipment, consumable
  • Test campaign – Supervision of the microbiological tests (several days):
    • 1. The validation engineer demonstrates the test with the first microorganism
    • 2. The technician(s) repeats what has been demonstrated on the further replicates and microorganisms
    • 3. Result read-out and interpretation
  • Duration: customized depending on customer needs

*Available for Steritest™, Steritest™ Symbio, Milliflex®, Milliflex Oasis®

Remote Validation Consultancy Service

If subcontracting to us the execution of your IQ/OQ/PQ Validation or Requalification is not an option in these times of social distancing, get expert support to execute it yourself from our Validation Engineers through a customized Remote Validation Consultancy. It all starts with an upfront discussion to understand your needs and size the consulting service. The coaching is then delivered live through a video conferencing system by our validation experts, covering topics as diverse as instrument and consumables usage training, good documentation practices, test plan set-up, data analysis, tips & tricks and much more.

Duration: Customized units of ½ day split over several calls.

*Available for Steritest™, Steritest™ Symbio, Milliflex®, Milliflex Oasis®, Milliflex® Quantum, MAS-100 NT®, MAS-100 VF, MAS-100 Iso NT, MAS-100 Iso MH, MAS-100 CG Ex, RCS High Flow Touch

On-Site Advanced Requalification Service

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
  • Provision of calibrated tools (flow meter, stopwatch, etc.)
  • Operator training review
  • OOS results review
  • Duration: 1 day, recommended frequency: every 3 to 5 years

*Available for Steritest™, Steritest™ Symbio, Milliflex®, Milliflex Oasis®

To learn more about our system qualification and requalifiation services, visit our “Systems Qualification” page.

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