(R)Evolutions of EU GMP Annex 1

Published on 02/09/2022

EU GMP Annex 1 is currently under revision. The text is becoming more structured, more logical and now requires a robust scientific approach.

The main changes are:

  • Expanded scope: the requirements of Annex 1 are now applicable to non-sterile manufacturing.
  • A principle to be robustly implemented: the Contamination Control Strategy (CCS)

Facility design and monitoring, specific technologies and cleanroom consumables are at the heart of your manufacturing processes.

 

Our products and services for your Contamination Control Strategy (CCS)

STERIGENE brings over 30 years of expertise and innovation to help you adapt as smoothly as possible. We are your single point of contact for finding the right solutions suited to your environment and tailored to your contamination control strategy:

  • Process Equipment: designing and delivering your projects with high-quality equipment
  • Technical Services: providing ongoing technical support for your equipment throughout its lifecycle
  • Consumables & Equipment: supplying products adapted to your Contamination Control Strategy

Expanded scope

  • Expertise: multi-disciplinary intervention capability throughout all phases of your projects
  • Training: customised training modules to understand and master the process equipment on your production lines
  • Validation: quality and metrology professionals to validate your equipment in accordance with EN 285 and EU GMP guidelines
  • Preventive maintenance: maintaining the operational capacity of your equipment and extending its service life

Facilities

  • Qualification & monitoring: covering all your ventilation equipment (excluding ductwork) across all critical environments
  • Furniture integration: design, manufacture and installation of cleanroom airlocks through our in-house engineering department
  • Controlled decontamination: comprehensive range of dry and pre-saturated wipes with low endotoxin and particle levels
  • Isolators & RABS: range of equipment with integrated monitoring and decontamination systems

Personnel

  • Goggles: multiple models available in single-use sterile or autoclavable versions
  • IT equipment: comprehensive range of ergonomic devices that are easily disinfectable
  • Aseptic gowning: range of validated sterile garments with packaging designed to guarantee sterility integrity up to the point of use
  • Masks & sleeve covers: cleanroom-validated materials available in sterile and non-sterile versions

Production

  • Aseptic filling: tailored solutions for liquid product filling, stoppering and sealing of vials, syringes, cartridges, bottles or carpules
  • Sterilisation: comprehensive range of sterilisation equipment using dry heat (ovens) or moist heat (autoclaves)
  • Visual inspection: automatic, semi-automatic or manual solutions to meet all your visual inspection requirements
  • Blow-Fill-Seal (Brevetti Angela): for the filling of sterile or particle-free liquid products


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