Specialty chemicals producer Clariant has produced a new amide/amine-free anti-static masterbatch concentrate for polyethylene films used in pharmaceutical production. The new anti-stat, marketed as MEVOPUR PEAM 176045, will be introduced at CPhI Worldwide, being held 24-26 October 2017 at Messe Frankfurt.
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, Clariants 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 cleanroom 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, Clariant`s brand of Controlled, Consistent and Compliant products for plastics applications in the medical and pharmaceutical industries.
When incorporated into polyethylene (PE) films Clariants new anti-static provides "very good static-dissipating performance and a competitive cost profile relative to alternatives," says the company. 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. below 25%), increasingly constrains these current technologies.
Existing products, often produced to a food-contact standard, fall short of new and more stringent standards, Clariants new PEAM 176045 additive concentrate becomes an ideal alternative, Duckworth asserts. It is fast-acting and long-lasting and amide/amine-free. It performs even at the low relative-humidity levels common to pharmaceutical cleanrooms. And, compared to other alternatives, including permanent or non-migrating additives, such as polyether block amide (PEBA), it can be effectively used at a far lower concentration and cost.
This is a product that film producers can adopt with an eye on present issues with migration limits and to the future, he adds, noting that Clariants MEVOPUR PEAM 176045 has been tested to support compliance with the upcoming USP changes, and has none of the migration-limit concerns.
As part of the MEVOPUR product line, the PEAM 176045 anti-stats are immediately available with declarations based on biological evaluation of raw materials per ISO 10993-4, -5, -10, 11 and USP, 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 colour and additive masterbatch concentrates and fully compounded plastics help manufacturers in the medical and pharmaceutical sectors control and minimise risk, while responding quickly to changing industry standards.
Besides the presence of Healthcare Polymer Solutions at CPhI 2017, please join also the experts from Clariants Business Unit Industrial & Consumer Specialties in meeting room Inspiration 1 in hall 10.2 to discuss and learn about Polyglykol and the Macrogol range.
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