Pharma Microbiology Method Development & Validation

Rely on Our Comprehensive Method Development and Validation Package Either On-Site or Remote

We have experienced and trained application and validation engineers who are skilled to assist in method development and validation 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 application or validation engineer’s visit.

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Method Development

Experimental study done in our application laboratory using your samples and microbial strain(s). Recommended in case of compatibility issues with standard protocol for testing new products. Development of an appropriate method to overcome any interference or to improve filterability.

This service is available for the Steritest™ system, the Milliflex Oasis^® system, the Milliflex^® Quantum system, the Milliflex^® Rapid system, the EZ-Fluo™ system, and the PyroMAT™ system.

On-Site Method Development Consulting

Consulting service by one of our application scientists to support your method development. Recommended in case of compatibility issues with standard protocol or for testing new products. One-day training at customer site covering platform use and how to develop an appropriate method. Customized test plan, real tests initiated on-site, then weekly follow-up calls to support customer.

This service is available for the Steritest™ system, the Milliflex Oasis^® system, the Milliflex^® Quantum system, the Milliflex^® Rapid system, the EZ-Fluo™ system, and the PyroMAT™ system.

Remote Method Development Consulting

Consulting service by one of our application scientists to support your method development. Recommended in case of compatibility issues with standard protocol or for testing new products. Remote training via videoconferencing system covering platform use and how to develop an appropriate method. Customized test plan, support to implement real tests, then weekly follow-up calls to support customer.

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

This service is available for the Steritest™ Symbio system, the Milliflex Oasis^® system, the Milliflex^® Quantum system, the EZ-Fluo™ system, the MAS-100 NT^® system, the MAS-100 VF^® system, and the RCS High Flow Touch system

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

This service is available for the Steritest™ Symbio system and the Milliflex Oasis^® system

Remote Method 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.

This service is available for the Steritest™ Symbio system, the Milliflex^® Oasis system, the Milliflex^® Quantum system, the MAS-100 NT^® system, the MAS-100 VF^® system, the MAS-100 Iso NT^® system, the MAS-100 Iso MH^® system, the MAS-100 CG Ex^® system, and the RCS High Flow Touch system

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

This service is available for the Steritest™ Symbio system and the Milliflex Oasis^® system

To learn more about our system qualification and requalification services, visit our Pharma QC Systems Qualification page.

Related Product Resources

Data Sheet: Milliflex^® Quantum Services
Data Sheet: PyroMAT^® kit Services
Data Sheet: Steritest™ Services
Data Sheet: Milliflex Oasis^® Services
Data Sheet: Microbiology Services
Data Sheet: Microbiology Services