(R)Evolutions of EU GMP Annex 1
Published on 02/09/2022
EU GMP Annex 1 is currently being revised. The text is becoming more structured, logical and demands a robust scientific approach.
The main changes are:
- An extended scope: the requirements of Annex 1 are becoming applicable to non-sterile manufacturing.
- A principle to be implemented robustly: the Contamination Control Strategy (CCS)
The design and monitoring of premises, specific technologies and cleanroom consumables are at the heart of your manufacturing processes.
Our products and services for your Contamination Control Strategy (CCS)
STERIGENE puts over 30 years of expertise and innovation at your service to help you adapt as smoothly as possible. We are your single point of contact for finding together the right solutions for your environment and tailored to your control strategy:
- Process equipment: designing and delivering your projects with quality equipment
- Technical services: providing technical follow-up services for your equipment
- Consumables and equipment: supplying products adapted to your contamination control strategy
The extended scope
- Expertise: ability to intervene at multiple stages throughout 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 capabilities of your equipment and extending its service life
Premises
- Qualification & monitoring: for all your ventilation equipment (excluding ductwork) across all critical environments
- Furniture integration: design, manufacture and installation of cleanroom airlocks through our design office
- 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
- Eyewear: several models available as single-use sterile or autoclavable
- IT equipment: comprehensive range, easy to disinfect and ergonomic to use
- Aseptic gowning: range of validated sterile garments with packaging guaranteeing sterility integrity up to the point of use
- Masks & sleeves: cleanroom-validated materials, sterile or non-sterile
Production
- Aseptic filling: adapted solutions for your liquid products — filling, stoppering and sealing of vials, syringes, cartridges, bottles or carpules
- Sterilization: comprehensive range of sterilization equipment using dry heat (oven) or moist heat (autoclave)
- Visual inspection: automatic, semi-automatic or manual to suit all your visual inspection needs
- Blow-Fill-Seal (Brevetti Angela): for filling your sterile or particle-free liquid products