MEVOPUR® anti-stat tested to new stringent regulations
Helps reduce risk and limitations of current technology
Maintains anti-static performance even at low humidity levels
Muttenz, September 26, 2017 - Clariant, a world leader in specialty chemicals, announces a new amide/amine-free anti-static masterbatch concentrate for polyethylene films used in pharmaceutical production. The new anti-stat, known under grade name MEVOPUR PEAM 176045, will be introduced at CPhI Worldwide, being held 24 - 26 October 2017 at Messe Frankfurt. Clariant is exhibiting on Stand 42L20.
The introduction is timely due to the changes in industry standards which, by 2020, will limit the acceptability of many of the currently used films that contain amide- and amine-based anti-stats, says Stephen Duckworth, Clariant's Head of Global Segment Medical and Pharmaceutical. For the first time, plastics used in pharma manufacturing, including anti-static films, will need to comply with the same standards as plastics packaging used for finished pharmaceuticals.
'Anti-static additives are routinely incorporated in the polyethylene 'clean-room films' that line containers and dispensers for active pharmaceutical ingredients (APIs), and in the tubes used to transfer powdered and liquid API during drug production. They are important because the anti-static properties help to reduce the risk of dangerous conditions like explosions,' he explained.
The new additive masterbatch concentrate is part of MEVOPUR, the brand of 'Controlled, Consistent and Compliant' products for plastics applications in the medical and pharmaceutical industries.
When incorporated into PE films Clariant's new anti-static provides very good static-dissipating performance and a competitive cost profile relative to alternatives. In addition, it has already been tested to the stricter new United States Pharmacopeia (USP) pharmaceutical standard for pharmaceutical-contacting plastics, which are scheduled to come into force in 2020. The new standard -- USP 'Plastic Components and Systems Used in the Manufacturing of Drug Products' -- will, for the first time, apply the same risk-based assessment of materials. Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, these plastic assemblies elicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety.
Historically, these anti-static films have predominantly relied on 'migrating' ethoxylated amine/amide-based anti-stats that had a degree of compliance to regulations for food contacting materials. Risk assessments that define migration limits applying to these additives cut allowable addition rates for amide- and amine-based additives to levels below of what is required for effective anti-static performance. This, in addition to the need to test at lower humidity levels (e.g.: , class VI. European Pharmacopeia and USP 661.1. This data, along with a ISO13485-based manufacturing/quality process, full change-control procedures, and documentation such as Drug Master File, help support the risk-management process of medical device producers. MEVOPUR 'Controlled, Consistent and Compliant' color and additive masterbatch concentrates and fully compounded plastics help manufacturers in the medical and pharmaceutical sectors control and minimize risk, while responding quickly to changing industry standards.
Besides the presence of Healthcare Polymer Solutions at CPhI 2017 please join also the experts from Clariant's Business Unit Industrial & Consumer Specialties in meeting room 'Inspiration 1' in hall 10.2 to discuss and learn about Polyglykol and the Macrogol range.
MEVOPUR® IS A TRADEMARK OF CLARIANT REGISTERED IN MANY COUNTRIES.