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Clariant Unveils Oxygen-scavenging Additive Masterbatch for Pharmaceutical Packaging

Published on 2020-02-10. Author : SpecialChem

TAGS:  Additives for Packaging    

Clariant has announced the addition of a new oxygen-scavenging additive masterbatch to its MEVOPUR® line of medical-grade materials and services for pharmaceutical packaging and medical devices. The new masterbatch concentrate and other innovations will be introduced at Pharmapack Europe. Clariant will exhibit in booth F54 at Porte de Versailles, Paris, France, on 5th and 6th February 2020.

Advanced Oxygen Scavenging System


MEVOPUR® ProTect is effective at limiting oxygen (O2) degradation of drugs and neutraceuticals stored in polyethylene terephthalate (PET) bottles, even in a transparent mono-layer construction.

Originally developed to overcome the deficiencies of existing oxygen barrier systems used in food and beverage packaging, the active molecules showed very high performance in scavenging oxygen permeating through container walls, and thereby maintains extremely low levels of O2 over extended periods even in a mono-layer and refrigerated storage. This makes it possible to meet the >2 years shelf-life required in pharmaceutical packaging, even with low concentrations of the active ingredient compared to alternative products. In addition, tests have shown that PET pre-forms do not need special storage conditions, still maintaining activity after 3 months.

ClariantO2 scavenger
The protection offered by the oxygen scavenging system depends on several factors including packaging design, additive loading, and target oxygen levels over time. However, by way of illustration, Clariant testing of 500ml monolayer PET bottles with 3.6% loading of the masterbatch concentrate was able to maintain oxygen levels below 1 ppm for more than 590 days, compared to just 22 days for untreated PET, and 63 days for a competitive oxygen scavenger.

Based on these test results, we believe that this is one of the most powerful oxygen-scavenging systems available for pharmaceutical packaging. However, it is also just one element in the process of bringing a pharma bottle to market. Complying with standards related to light transmission, extraction and leachables, and so on must be considered in the final materials formulation It is important to take a total system approach to pharmaceutical packaging applications and the healthcare polymer solutions team has the extensive formulation and regulatory know-how to help customers avoid potential problems,” said Steve Duckworth, global head of marketing & business development for Clariant healthcare polymer solutions.

Reducing the Risk of Regulatory Non-compliance


The year 2020 marks the 10th anniversary of the creation of the MEVOPUR® product range, which helps manufacturers of pharmaceutical packaging and medical devices reduce the risk of regulatory non-compliance throughout the product life cycle, while meeting the highest standards for performance and appearance.

All MEVOPUR® compounds and concentrates are produced in three dedicated EN:ISO13485-2016 certified facilities and use ingredients that have been pre-tested to ensure compliance with applicable standards for both medical devices and pharmaceutical packaging. For pharmaceutical packaging applications the MEVOPUR® range offers one of the most comprehensive regulatory support services available, including testing ingredients in accordance to USP 661.1, EP3.1., ICHQ3D (USP<232>), and biocompatibility per USP<87>, <88>.

The MEVOPUR® ProTect product is offered with the same regulatory test documentation.

Protection of the drug is not the only area where MEVOPUR®ProTect could offer a solution in O2 protection. “In diagnostic applications, oxygen can interfere with the sample/reagent combination, affecting the accuracy of the analytics. Therefore, we expect some interest in MEVOPUR® ProTect in these PET applications as well,” Duckworth commented.
 


Source: Clariant
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