Pharma QC Systems Qualification

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

cGMPs/cGLPs require equipment and test methods 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 by our experts to save time.

Reduce Development Time & Validation Cost

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.

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Related Technical Resources

Data Sheet: Milliflex Oasis^® Services
Brochure: Microbiology Services
Data Sheet: Services Portfolio Supporting the Milliflex^® Quantum System for Bioburden Testing
Data Sheet: Services Portfolio Supporting the PyroMAT™ Kit for Pyrogen Detection
Data Sheet: Services Portfolio Supporting the Steritest™ Family for Sterility Testing
Brochure: Training Program

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

We have experienced and trained validation engineers 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 QC testing equipment.

Validation Protocols

Our validation protocols are based on our internal product qualification test methods. These extensive protocols will enable the QC/QA Lab to quickly initiate your Validation Master Plan and perform IQ, OQ and PQ (requalification) with ease. They follow international guidelines such as EP/USP and GMP.

* 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 IQ/OQ Service

Support for the qualification of your laboratory equipment:

• Execution of the test methods
• IQ and OQ sections of the final report is completed, ready for QA approval
• Operator training
• Duration: minimum 1.5 day depending on number of systems and consumables to be validated

* 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

Remote Validation Consultancy Service

If subcontracting to us the execution of your IQ & OQ 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 Essential Requalification Service

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
• Furniture of calibrated tools (flow meter, stopwatch, etc.)
• Duration: 0,5 day, recommended frequency: every year

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

To learn more about our method validation and other consultancy services, visit our “Method Development and Validation” page.