Journal of Austrian Chemistry

Journal for the Chemical Industry in Austria

Clariant

Clariant: Bulk Pharmaceuticals Focus at Pharmapack 2019

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Clariant and its Healthcare Packaging business line are exhibiting at Pharmapack 2019 and featuring products that protect the quality and appearance of bulk pharmaceuticals (powders, tablets, capsules, etc.), as well as active ingredients (API) during processing and shipment.

Clariant experts will be on hand to introduce visitors to three distinct solutions that protect against damage caused by high and low humidity levels, and oxidation. All three are produced in new ISO 15378 GMP certified facilities in Belen, New Mexico, USA, Romorantin, France, and Donguan, China.

“It is common practice to include desiccants and other controlled atmosphere products in end-market packaging,” explains Dr. Elisa Le Floch, Business Development & Marketing Manager, Clariant Healthcare Packaging, “but it is just as important to control moisture and oxygen in bulk packaging, to extend shelf-life and prevent degradation and future processing or assembly problems.”

The simplest solutions use desiccant. Sorb-It PHARMA bags, are filled with silica-gel desiccant, while Tri-Sorb® PHARMA bags employ a molecular sieve. Placed inside packages of bulk or finished drugs or work-in-process APIs, these bags adsorb any moisture in the product, or the air surrounding it, to provide a low-humidity environment. Without such protection, moisture can cause a loss of drug potency, caking and clumping that affects material flow, among other problems. The desiccant bags comply with U.S. Pharmaceopeia USP<670> testing requirements for Auxiliary Packaging Components. They are available in a range of standard and custom sizes to suit specific application requirements.

For certain pharmaceutical products, a simple desiccant may not provide the protection required. For these applications, moisture must be controlled to certain specific levels. Powders, for instance, can cake or clump when exposed to too much moisture, while too little can cause undesirable static electricity. Oral forms, such as tablets or gelatin capsules, need a certain amout of moisture to maintain plasticity and prevent brittleness. Even plastic parts used in medical devices, when stored in bulk packaging, can pick up electrostatic charges if the environment is too dry.

For these types of bulk applications, Clariant recommends EQius bags. EQius products are made using specially engineered sorbents that can act as humectants (desorbers) and desiccants (adsorbers) simultaneously, maintaining a particular equilibrium relative humidity (ERH) inside product packaging. This line of standard equilibrium-stabilizer products can maintain specific ERH levels between 10 and 60% to help bulk ingredients in boxes or bags maintain their physical integrity.

“In other bulk applications, pharmaceuticals need to be protected not only against moisture but also against the harmful effects of oxidation. Oxygen can cause several kinds of degradation, a change in color or smell, a change in pH or other molecular properties, or physical changes. In these cases, PharmaKeep Oxygen Absorbing Desiccant Bags (branded & produced by Mitsubishi Gas Chemical Company and distributed by Clariant Healthcare Packaging) is the recommended solution. PharmaKeep can adsorb both oxygen and moisture to prevent both oxidation and hydrolysis. This makes it an ideal alternative to conventional oxygen absorbers, which may actually require moisture for effective oxygen absorption, or complex and expensive processes such as nitrogen protection, vacuum or negative-temperature regulation. In addition, PharmaKeep oxygen absorber bags may be a good solution for large pharmacies that handle bulk quantities of tablets and use automatic dispensing machine,” Stephane Rault, Product Manager at Clariant, explains.

The show takes place in Paris 6 & 7 February 2019 and Clariant is exhibiting on Stand D20.

About CLARIANT

Clariant Healthcare Packaging offers full line of controlled-atmosphere packaging solutions including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers. Using both active and passive packaging technologies, Clariant offers an array of standard components and complete systems, as well as full innovation and development capabilities. By understanding customer needs and expectations, Clariant is able to offer comprehensive and viable solutions that increase efficiency, reduce costs and improve the environmental compatibility of products.

Clariant MEVOPUR Certified Compliant with New ISO 13485 Standard

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Clariant, a world leader in specialty chemicals, announces that its recently expanded facility in Lewiston Maine, and two other sites in Malmo, Sweden, and Singapore, have been certified to the stringent new quality standard for makers of plastic medical devices. The plants produce specialized polymer compounds and masterbatches offered for medical applications under the MEVOPUR brand.

After a 3-year transition period during which manufacturers could continue following an earlier version, ISO 13485-2016 goes into full effect at the end of February 2019. Device submissions under the old version will no longer be allowed.

“The completion of this process is a perfect example of Clariant’s strong commitment to creating value for its customers,” said Deepak Parikh, President, Region North America. “Demand is increasing for specialized, medical grade compounds and masterbatches. Compliance to the new standard and the significant expansion, will enable our state-of-the-art Lewiston facility to continue to globally deliver to our customers – high value products with unique technologies.”

Although ISO 13485 technically only applies to producers of medical devices, it is seen as an important standard for their suppliers, like Clariant, because it helps reduce risks such as risk of changes in raw materials impacting device performance, reliability, or regulatory compliance. Increased use of QbD (Quality by Design) processes means that more consideration needs to be given to materials used and impact on patient safety.

“With the introduction of the new standard and increased assessment of risk related to materials and change management, medical device and pharmaceutical companies may need to re-evaluate their reliance on materials and methods of the past,” explains Steve Duckworth, Head of the Global Medical and Pharmaceutical Segment for Clariant Plastics & Coatings. “Increasingly, they will need to ensure trust by using expertise coming from materials suppliers – like Clariant — who have a good understanding of and products adapted to the needs of the healthcare market.

Clariant began introducing the MEVOPUR family of products and services more than a decade ago, to help minimize risk at every stage of a medical device’s life cycle. A global team of specialists from R&D, production, sales and marketing, and customer service, works closely with individual customers to pre-test materials and assess risk in order to build compliant, targeted color and functionality into each application.

The three global facilities, almost entirely dedicated to medical and pharmaceutical applications, provide assurance of consistency in formulations and procedures, and supply-chain reliability for all MEVOPUR products. Raw materials are pre-tested to standards commonly required for device and drug filings, e.g.: USP <87><88> (‘USP Class VI’) and ISO10993, as well as the USP<661.1>, ICHQ3D and European Pharmacopeia monographs 3.1 covering drug packaging and delivery devices. Segregated storage and manufacturing lines, plus scrupulous change-control processes, reduce the risk of cross contamination. The desire to comply with the requirements of the new ISO 13485-2016 standard presented additional challenges, however. For example, for the first time, computerized systems needed to be risk-assessed, and then the appropriate validation or verification activities carried out. Even if software is not directly controlling processes, it often present in test equipment used to control raw materials or end-product quality. The project to implement the new version ISO13485-2016 was conducted on a global basis with local site quality managers supported by Clariant’s dedicated Global Quality & Regulatory manager for the healthcare sector.