About

NAON supports Annex 1 assessments, aseptic process improvement, contamination control strategy development, project management, implementation and qualification in regulated sterile manufacturing environments, with access to a broad network of European sterile manufacturing experts.

Get in Touch

How

works

A clear path from assessment to implementation

Assessment first.

Projects start with a targeted review of gaps, risks and implementation priorities.

Single point of contact.

One clear point of coordination from assessment through implementation and qualification.

Practical delivery support.

Support focused on execution, not slide decks.

European expertise when needed.

Selected specialist input can be brought in for defined technical scopes.

Experience behind

NAON builds on deep experience in sterile filtration, aseptic processing, Annex 1 implementation and project delivery in regulated biopharmaceutical environments. This includes work on PUPSIT concepts, sterile filtration modernisation, line integrity, authority-facing Annex 1 topics and the introduction of single-use technologies to strengthen aseptic assurance.

Member & Author of the Parenteral Drug Association (PDA).

Previous Projects

PUPSIT implementation

Design and implementation of Annex 1 – compliant PUPSIT strategies in legacy facilities, from feasibility and URS to qualification and inspection defense.

Sterile Filtration Integrity

Development and optimization of sterile filtration concepts, including single-use systems, integrity test strategies, and lifecycle documentation for global sterile drug manufacturers.

Hygiene Concept & CCS

Support and upgrade of contamination control strategies and hygiene concepts, linking facility design, cleaning and disinfection and gowning to a coherent CCS framework.

Process Optimization

Support for global pharma sites to troubleshoot and optimize aseptic processes and address inspection findings without compromising sterility assurance.