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.

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.

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...

Working as a senior quality engineer

Jakob Zoffmann Petersen can bake a mean cake, but now he works as a senior quality engineer in Quality & Validation . Read why he finds quality and validation so interesting, and the challenging environment around him so intriguing. As a senior quality engineer in Quality & Validation , I try to get to know the customer so that I truly understand their needs. What is it like to work in quality and validation ? When people hear the words “quali...

Cleanroom Expo Denmark 2021

MEET NNE Our cleanroom test experts,   André Campos Lourenço  and  Helene Heilmann , will share their insights on how to ensure compliance through testing and validation of cleanrooms.

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.

TechTalk

Closed systems’ impact on facility design | TechTalk

While it is the manufacturer’s responsibility to define and prove closure for a process step, there are some general attributes of closed systems: Closed systems utilize processing equipment that does not expose a product to the external environment They allow materials to enter or leave a system via predetermined control paths Closed systems can be validated to prevent unwarranted material exchange between the process and environment But thes...

Becoming a quality engineer

Of course, I have traditional quality and validation as well, such as writing specifications, protocols, and validation documents. We are a new department in that it’s a merging of two departments (the Computer System Quality team from Manufacturing IT and Quality & Validation ).