MAS-100 NT^® Customer Validation Protocol

Microbiological monitoring and testing in the pharmaceutical industry are highly regulated and a very complex field. In our long history of serving the pharmaceutical industry by pioneering and refining ground-breaking solutions, we have gained the regulatory and technical expertise to make compliance as simple as possible, and help save your valuable resources, by providing comprehensive range of professional and best-in-class services. Our Customer Validation Protocol makes validation faster, easier and ensures that your MAS-100 NT^® portable air sampler, accessories and related consumables do comply with the validated specifications. Our bioburden validation protocols follow international guidelines such as EP/USP and GMP.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 MAS-100 NT portable air sampler while reducing the risk of breakdown.

Our validation protocols are based on our internal product qualification test methods. These extensive protocols will enable the QC/QA lab to quickly initiate the validation master plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease.

Count on our comprehensive and ready-to-use validation protocols consisting of the following sections:

• Validation Master Plan: Define structure, responsibilities for qualification.
• Installation Qualification (IQ)

Verification and identification of with your MAS-100 NT^® portable air sampler, accessories and related consumables.
Verification of product′s utilities and operating environment requirements.
Equipment and personnel preparation.

• Operational Qualification (OQ): Verification of product′s functionality (hardware, software, devices).
• Performance Qualification (PQ) Test Method suitability verification (microbiology validation procedures).
• Final Report Summarizes all testing performed for final approval of validation.

MANTLTVP2 is not a stand-alone product. It must be purchased along with MANTLTTR1 as a mandatory combination.

MAS-100 NT is a registered trademark of MBV AG