Citation: Bailly A, “Product Showcase: PremiumCoat™“. ONdrugDelivery Magazine, Issue 73 (Feb 2017), pp 38-39.
PremiumCoat™ (Figure 1) is a novel range of elastomeric stoppers developed by Aptar Pharma and based on an approved, pure, state-of-the-art formulation. The surface of the elastomer is coated during manufacturing with a thin fluoropolymer film (Figure 2). This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer. As a result, compatibility of the drug and the closure is significantly superior.
The first design to be released in 2015 was a 20 mm coated stopper. We widened our PremiumCoat™ range introducing a 13 mm coated stopper in 2016, and we are now striving to extend our offer with our 1 mL plunger. Biopharmaceuticals are very sensitive in nature and prone to interaction with the rubber of the stopper. The challenge, therefore, is to maintain the integrity of the container closure while minimising interaction between the formulation and the components of the elastomeric closure system. It was to meet this demand that Aptar Pharma developed the PremiumCoat™ range of elastomeric stoppers.
Our experience in elastomeric closures and container closure systems is supported by the capabilities of our International Technical Center in Villepinte, France. This state-of-the art facility has been specifically designed and equipped for mechanical, functional, chemical, container closure integrity and microbiology/particle testing. A pioneer in proprietary designs and finishing processes which have now become industry standards, our team of technical and scientific specialists pursues the development of tomorrow’s products and processes.
US FACILITY EXPANSION
Furthermore, in Congers, NY, US, Aptar Pharma is also nearing completion of its expansion at its state-of-the-art manufacturing site (Figure 3). The new space will enable the company to better serve North American pharmaceutical customers, as injectable elastomeric component manufacturing will be completed in the US for the first time by Aptar.
Final construction is planned by the end of the first quarter of 2017 so that Aptar Pharma can anticipate shipping validation batches to customers in the second quarter. The expansion is part of a stepped program to increase Aptar Pharma’s footprint in the US.
The increased facility space enables the company to conduct all of our finishing operations in the US, including PremiumCoat™. Bas Van Buijtenen, President of the Injectables Division of Aptar Pharma, said: “We are bringing all of our knowledge and the value-adding parts of our process closer to the customer. We want our customers to know us better, to understand what we can do for them on an entirely different level.”
PREMIUM SOLUTION PROVIDER
Our elastomeric closure solutions comply with the highest industry and regulatory standards. Our state-of-the-art, cGMP compliant manufacturing processes include automation, camera inspection and classified cleanrooms. In addition, our team of experts, quality system and procedures support these production processes up to and including sterilisation – a premium quality environment for your drug products.