Updates to Appendix 1 of the EU GMP
BE PREPARED BY CHOOSING THE RIGHT PRODUCTS AND SERVICES!
Appendix 1 of the EU GMP is currently being revised. The text becomes structured, logical and requires a robust scientific approach.
The main changes are:
- Expanded scope: the requirements of Appendix 1 become applicable to non-sterile manufacturing.
- A principle to be thoroughly implemented: the Contamination Control Strategy (CCS)
- The design and monitoring of premises, specific technologies or room consumables are at the heart of your manufacturing processes.
Be prepared: contact us for your selection of products and services!
OUR PRODUCTS AND SERVICES FOR YOUR CONTAMINATION CONTROL STRATEGY* (CCS)
STERIGENE puts more than 30 years of expertise and innovation at your disposal so that you can adapt as easily as possible. We are the single point of contact to find the right solutions for your environment that are adapted to your control strategy:
Process equipment: design and execute your projects with high-quality equipment
Technical services: provide technical monitoring services for your equipment
Consumables and equipment: provide products to suit your contamination control strategy
The expanded scope
- Expertise: capacity for multiple operations 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 according to EN 285 and the EU GMP
- Preventive maintenance: maintaining the operational capacity of your equipment and extending its lifespan
- Qualification & monitoring: for all of your ventilation equipment (excluding ducts) for all critical environments
- Furniture installation: manufacture, design and installation of airlocks for cleanrooms by our design office
- Controlled decontamination: full range of dry and pre-saturated wipes with low endotoxin and particle levels
- Isolators & RABS: range of equipment with integrated monitoring and decontamination system
- Glasses: several sterile disposable or autoclavable models
- Computer equipment: a complete range that is easy to disinfect and ergonomic to use
- Aseptic garments: a range of validated sterile garments with packaging to ensure sterility integrity up to point of use
- Masks and cuffs: cleanroom materials certified sterile or unsterile
- Aseptic filling: adapted solutions for your liquid products: filling, capping and sealing vials, syringes, carpules, bottles or cartridges
- Sterilisation: full range of dry heat (oven) and wet heat (autoclave) sterilisation equipment
- 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