RayDyLyo® is the new all-plastic push-fit cap for closing vials of injectable drugs. Unlike alternative to the aluminum crimp cap, RayDyLyo® makes it possible to pre-assemble the stopper in the cap and simplify the production process. It allows pharmaceutical companies to accelerate the time to market of new drugs.
The RayDyLyo® range simplifies production processes and meets the need for flexibility of manufacturers of new molecules (cell therapies, biosimilars, oncology, monoclonal antibodies), from the development phase to mass production.
In response to regulatory changes, particularly in aseptic filling (Appendix 1 GMP), RayDyLyo® eliminates crimping for both liquid and lyophilized forms.
It is available in 13 and 20 mm diameters to suit different vial sizes.
RayDyLyo® is suitable for use manually in clinical batch production as well as filling in isolators and serial production on filling lines. RayDyLyo® is suitable for clinical batch production and small batches. It allows filling and capping in the aseptic area. Manual capping is easy and safe needing only simple vertical pressure without any special tools. RayDyLyo® is fully tamper evident and eliminates cosmetic defects on closures.
Benefits
• No human intervention is necessary, which guarantees sterile filling.
• This RTU solution is unique: it guarantees sterile, reproducible manufacturing conditions.
• It offers greater flexibility – switching drugs between two production runs is faster – and is clearly a timesaver.
• Fast changeover between drug products
• Suitable for small to medium size batches
• No glass-to-glass contact
• Nested component products
• No need to de-nest for capping