MAS-100 NT^® Portable Air Sampler Digital Validation Protocol

EP
JP 4.06
USP

pharmaceutical

for use with MAS-100 NT^®

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 Digital 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 using our new 21 CFR part 11 compliant Online Validation Platform called Val@M^™.Rely on comprehensive and ready-to-use validation packages made of our digital protocol to be combined with our on-site IQ & OQ execution service.Ensure the performance of your MAS-100 NT^® portable air sampler while reducing the risk of breakdown.

Count on our comprehensive and ready-to-use digital 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 products utilities and operating environment requirements.Equipment and personnel preparation.Operational Qualification (OQ): Verification of products 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.

MAS-100 NT is a registered trademark of MBV AG
Val@M is a trademark of Merck KGaA, Darmstadt, Germany