22 Avenue of Nations,
95944 ROISSY CDG Cedex - France
33 + (0) 1 48 63 56 56
Your partner worldwide, specialized in manufacturing high components elastomer range for injectable products.
We offer elastomer components that meet the most stringent pharmaceutical requirements. Our manufacturing processes, GMP, are at the forefront of technology: automation, vision systems by camera, cleanrooms ISO 5 ... These methods including sterilization steps are guaranteed by our quality system and procedures - a high quality environment for your drugs.
global leader and preferred partner
Our organization and our offer is structured to facilitate the implementation of strategies and meet your needs with the objective of adding value sustainably. This strategy has enabled us to become a leader in this very demanding market.
Quality, innovation and customer service are our strengths recognized around the world and form the cornerstone of the special partnership we have built with our clients.
Pioneering products and cleaner processes that have now become industry standards, our technical and scientific experts teams design products and processes in our future International Centre Technique
COMPONENTS FOR PRE-FILLED SYRINGES AND CARTRIDGES
- Shin Needles
- Tip Caps
- Components for Cartridge
- parenterals high volume (LVP)
- parenteral preparations in small volume (SVP)
- Ready to be sterilized
- aseptic systems transferred
- PremiumCoat ™
PremiumCoat™ The alternative stoppers coated for sensitive drugs.
Fragile injectable drugs with very high value added, a dynamic market
The biotech drugs include many complex and sensitive molecules produced artificially through organic agents grown in living systems such as microorganisms, plants or animal cells, they represent a major therapeutic advance.
The biotechnology market is 20% of the world pharmaceutical market with an average annual growth of 10% between 2010 and 2015 or 2 times a growth higher than the global drug market.
sensitive injectable drugs require high-end components
The biotech drugs are unstable and fragile in nature. Also, it is extremely important to maintain the integrity of the closure and minimize the interaction container / content. The use of a conventional elastomeric stopper may not be the optimal solution for these fragile drugs.
PremiumCoat™ launched early 2015 is a new range of elastomeric stoppers developed by Aptar Stelmi from a premium formulation, pure and approved.
The surface of the elastomer is coated with a thin film ETFE during manufacture of the cap. This film acts as an effective barrier against most of extractables and leachables compounds that could be released from the elastomer. And the compatibility of the medication with the cap is significantly enhanced by PremiumCoat™.
Our first design the 20 mm was launched in February 2015 2016 and February, we completed the range with 13 mm coated.
Around the world, technical experts and technical-regulatory closer to our customers
As a true partner, you can count on us: we provide comprehensive technical and regulatory services throughout the lifecycle of your product, that is to say, from development through validation, industrialization , regulatory registrations and post-launch tracking.
We can provide full documentation so you can make the right choice for premium products: specifications, information sheets, technical studies, technical and regulatory information, validation records and technical bulletins.
Our engineers are working internally and with you to meet your needs processes, product improvement, development of customized products to help you get started on the drug market safely and quickly.