EASTMAN CHEMICAL COMPANY: Eastar PETG copolyester selected for break-resist pharmaceutical serum vials

FEB 24, 1999, M2 Communications - As an alternative to fragile borosilicate Type I glass, Nalge Nunc International (Rochester, N.Y.), a leading supplier of laboratory containers, is now offering serum vials molded of Eastar PETG copolyester produced by Eastman Chemical Company (Kingsport, Tenn.). Plastic vials are safer than glass vials and at least 40% lighter, offering a substantial reduction in shipping costs.

When dealing with biologically active materials such as liquid diagnostics, ophthalmic solutions, and human and veterinary pharmaceuticals, two primary concerns are maintaining the sterility of the products and preventing humans from being unintentionally exposed to them. This is especially true when these products are shipped in serum vials that are subject to breakage, making both products and people vulnerable.

"The products our customers package in these vials can be biologically active," said Peter Charleton, product manager, Packaging Products, Nalge Nunc, "and are frequently very valuable as well. Glass offers the optical, chemical and barrier properties this application requires but is, unfortunately, fragile and subject to breakage.

"Glass-clear vials made of Eastar PETG copolyester allow quick and easy visual inspection, and because they are break-resistant and very resistant to most chemicals, the end user is protected from possible injury and exposure to infectious or hazardous materials. The plastic vials also eliminate the problem of having to discard an entire tray because of one broken glass vial, and they prevent freeze/thaw breakage. Cost savings can be very substantial."

Nalge Nunc evaluated a number of plastics for this application, including polycarbonate, acrylics and cycloolefins. Eastar PETG copolyester was selected for its clarity, chemical resistance and barrier properties, especially its impermeability to oxygen and carbon dioxide.

"We were already familiar with Eastar PETG copolyester," said Ken Falkowitz, manager, Market Development, Nalge Nunc, "because we were using the material in bottles for cell culture media, so we didn't need to start from scratch." The finished product is nonpyrogenic and noncytotoxic, and the PETG resin contains no extractable alkalis that can cause pH shifts.

"Another important consideration was sterility," said Falkowitz. Eastar PETG copolyester can be sterilized with either gamma radiation or ethylene oxide without clouding or weakening. Vials made by Nalge Nunc are packaged in tray-less shrink-wrapped bricks, which are double bagged and sealed in polyethylene liners and placed in kraft cartons. The finished product is then processed at a gamma irradiation facility to achieve sterilization. The complete packaging configuration has been subjected to an aerosol spray challenge to validate package integrity and sterility.

"An added advantage of this type of packaging," said Charleton, "is that eliminating trays allows the shrink-wrapped units to be fed quickly and easily into the customer's filling line. They can be filled faster than glass vials because the line can be run at higher speeds without danger of breakage, and their flat bottoms provide stability to prevent jams."

The vials are available in several configurations ranging in capacity from 3 to 20 mL. A crimp finish accepts a septum or stopper and is commonly used for injectable serums. A continuous thread finish accepts a screw-on cap and is often preferred for packaging diagnostics. Both configurations are available in either clear or transparent amber Eastar PETG copolyester. All materials meet ISO/FDA 10993 criteria, including USP Class VI in terms of biocompatibility, and all meet FDA CFR21 177.1315 requirements for food and beverage use. The amber versions meet USP light-transmission requirements.

Eastar PETG copolyester is marketed globally by Eastman. "Because of its unique balance of properties, it is often used in medical packaging applications," said Doug Small, Eastman business manager. "An added advantage is that Eastar copolyester is an environmentally preferred material, and when incinerated, its only by-products are water and carbon dioxide."

Eastman Chemical Company, headquartered in Kingsport, Tennessee, U.S.A., manufactures and markets plastics, chemicals and fibers worldwide with 1997 sales of US$4.68 billion. The quality systems of all Eastman plastics are registered under ISO 9000 except at plants in operation less than one year.

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