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.
Optimize or simplify your method for easy validation and cost-effective testing.
Optimize your QC lab workflow and ensure regulatory compliance With our long history of serving the pharmaceutical industry, we have pioneered and refined ground-breaking solutions, demonstrating the regulatory and technological expertise to share this know-how with our customers to make compliance as simple as possible and help save your valuable resources.
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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:
Quickly integrate equipment into your process pipeline with confidence using product specific test methods.
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.
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
Support for the qualification of your laboratory equipment:
* 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
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
Requalification work performed on laboratory equipment after the yearly preventive maintenance:
* Available for Steritest™, Steritest™ Symbio, Milliflex®, Milliflex Oasis®
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