Interphex: Cryovac introduces next-generation sterilizable medical film

A leading expert for over 20 years in manufacturing films for ostomy applications, Cryovac Division, Sealed Air Corporation has created the next generation of pharmaceutical solutions containers for applications including parenteral nutrition, IV, irrigation, peritoneal dialysis, continuous ambulatory peritoneal dialysis (CAPD), antibiotics and specialty drugs. Cryovac M312 represents the culmination of more than 15 years of product development in cooperation with several major pharmaceutical companies.

Through its leadership in coextrusion technology, Cryovac has engineered flexible polyolefin materials that are the leading containment options for pharmaceutical solutions.

Durable yet thin, sterilizable at 121 degrees Celsius, resistant to temperature extremes in storage and distribution, Cryovac M312 medical film possesses superior leach resistance, has an extremely low moisture-vapor transmission rate and does not contain chlorine or DEHP plasticizers.

"M312 film is designed to meet the demanding needs of medical packaging applications," said Jake Chadwick, General Manager Medical Packaging for, Sealed Air Corporation. "Cryovac's technology in developing M312 ensures the integrity of the solution from the time that it is contained in the film throughout its use in a pharmaceutical solutions application."

Benefits

Cryovac's exclusive multi-layer coextrusion technology uses a proprietary process that includes several polymers, each contributing a specific property. The polymers are coextruded into a multi-layer film. The result is an exceptionally clear, extremely tough film with a wide range of superior physical properties. The chemically inert M312 has extremely low levels of extractables, and meets USP Physicochemical and Biological Class VI requirements. The material is compatible with an array of pharmaceutical solutions including a variety of lipids and amino acids.

The low moisture-vapor transmission rate of M312 reduces and in some cases eliminates the need for overwrap. Its low-temperature flex crack and fracture resistance provides major advantages for distribution and storage in cold conditions—for instance, even if subjected to below freezing temperatures, CryovacÒ M312 safely maintains and protects the product inside.

M312 polyolefin film has superior leach resistance. Therefore, no extractables or by-products can migrate from the bag into the pharmaceutical solution.

This very thin, yet highly effective film takes less time to sterilize in an autoclave because the heat transfer is better than in thicker plasticized PVC. Because an M312 primary bag has less than half the mass of a PVC bag, waste volume and disposal costs are significantly reduced.

Manufacturing

The manufacturing process is conducted within a controlled environment, and the film is extruded as a tube keeping the solution contact surface on the inside. The tube is filled with Class 100-filtered air during this proprietary extrusion process, practically eliminating contamination of the solution contact surface.

The film is produced in a "double wound" format so the solution contact surfaces are never exposed to the environment. The solution contact surfaces remain clean and exposure to microorganisms or particulate matter is negligible. Special packaging techniques are used to preserve this cleanliness during transportation and to eliminate the introduction of contaminants into the "clean room" bag-making environment.

Emphasis from the beginning has been on engineering a highly inert material that exhibits extremely low extractables among a wide variety of solutions, even after sterilization.

The result is a superior alternative to glass bottles, flexible PVC bags and other containers for general and specialized parenteral products.

About Cryovac

Cryovac, headquartered in Duncan, S.C., is a world leader in high performance packaging systems for the food processing, supermarket, food service, industrial and consumer goods, medical and pharmaceutical industries. Cryovac provides packaging solutions for customers around the world through a combination of equipment systems development, applications, technical services and marketing support.

Sealed Air Corporation, based in Saddle Brook, NJ, is a leading global manufacturer of protective and specialty packaging materials and systems. Sealed Air Corporation, which has annual sales in excess of $2.8 billion, employs over 15,000 people in more than 46 countries worldwide.

For more information: Jake Chadwick, GM, Medical Packaging, Cryovac Division, Sealed Air Corp., 100 Rogers Bridge Road, Building A, Duncan, S.C. 29334-0464. Phone: (864) 433-2000. E-mail: cryovac.mkt@sealedair.com.

Source: Cryovac

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