Projects

Qualification and validation of GMP vaccine facility

Find out how NNE’s qualification and validation team helped GSK Biologicals’ build a new GMP vaccine plant in time to meet seasonal production demands.

Projects

Risk-based approach to GMP process validation

Beijing Fresenius Pharmaceutical needed an experienced partner to establish a new validated pharma production facility with European equipment. The company approached NNE looking for a new facility, including process validation up to the start of commercial production. NNE's solution was a turnkey facility and support with the complete qualification and process validation – from validation master plan up to the start of commercial production....

Growing every day as validation engineer | NNE

Marwa Adlouni highlights the development opportunities, the variety in tasks and the strong sense of unity as the major reasons for why she thrives in her job a validation engineer at NNE.

Projects

Validation transformation from C&Q to ASTM E2500

When  Pfizer  wanted to change its traditional approach to validation , NNE’s in-depth knowledge of the new  ASTM E2500  "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment" made us the obvious choice to help out. Focus on what is critical to the patient In general, the pharmaceutical industry has increased spending on documenting validation activities over the...

Services

Cleanroom testing and validation | NNE

NNE offers a range of services within cleanroom testing and validation to make sure that your cleanroom is inspection-ready.

Services

Independent and tailored medical device testing | NNE

We cover all facets of testing, ranging from feasibility/explorative testing to full design verification testing using validated test methods, based on three key elements: First-hand ISO standard and device test regulatory knowledge Complying with standards is rooted in our DNA. Robust test methods We offer tailored testing, which means that we are flexible and will develop and validate unique test methods for your specific needs. ce Physical...

Offices

NNE in Germany | NNE

See our projects, events, employee testimonials and get in contact with our team in Germany.

Projects

Biotech bulk plant complete with automation system

This included procuring and managing many prefabricated complete units, as well as performing detailed design and validation of other parts of the facility. Major validation within a short timeframe The project included a major validation effort as well as one of the largest and most advanced  part 11 -compliant automation systems in the world.

Statistical process control (SPC), MSA and capability 1

It covers prediction of the future from historical data, the original idea of process validation . Your benefits After participating in this course, you will be able to: Create measurement uncertainty budgets (MUB), which is used to ensure the quality of your measurements used in the production and validation Use advanced sampling statistics methods to ensure the right sample size for batch release, qualification and validation Calculate the...

This module build on the Statistical process control (SPC), MSA and capability 1 and 2 and and focuses on expert level applied statistical tools you can utilise in your daily work.

It covers prediction of the future from historical data and the original idea of process validation . Your benefits After participating in this course, you will be able to: Create Measurement Uncertainty Budgets (MUB), which is used to ensure the quality of your measurements used in the production and validation Use advanced sampling statistics methods to ensure the right sample size for batch release, qualification and validation Calculate th...