Discover your next big idea at PACK EXPO Las Vegas this September
Experience a breakthrough in packaging & processing and transform your business with solutions from 2,300 suppliers spanning all industries.
REGISTER NOW & SAVE

Aseptic drug filling boasts new type of sterilization

Sterilizing a depyrogenation tunnel by means of vaporized hydrogen peroxide is a first at Organon’s recently installed vial filling line.

This drawing shows the U-shaped aseptic filling line from beginning to end.
This drawing shows the U-shaped aseptic filling line from beginning to end.

A new aseptic vial-filling line at Organon Ltd. in Dublin, Ireland, represents the very latest in aseptic sterilizing and filling technologies that have come into the pharmaceutical industry in the past few years. Capable of sterilizing, filling, stoppering, overcapping and tray-packing 300 vials/min, the line requires only three operators.

It’s also one of the first commercial applications of a patented system for sterilizing a depyrogenation tunnel with vaporized hydrogen peroxide.

Organon uses its new line to fill 2”-tall glass vials with 0.6 mL of a hormonal fertility treatment called Puregon® Solution. Women can receive the treatment either by self-administration or by their doctors via a hypodermic needle. Until this product presentation was available, these products were only available freeze-dried, so they had to be reconstituted before injection. Those products remain available. But by adding a dissolved drug in glass vials as an alternative delivery system, Organon can offer its product as a convenient, ready-to-use medication as well.

Many pharmaceutical products are filled into vials, stoppered and capped in a cleanroom environment and then terminally sterilized in a high-heat environment. But terminal sterilization was not an option in this case because the products being handled could be damaged if exposed to high temperatures.

“The alternative to terminal sterilization is aseptic filling,” says Tony Byrne, technical services manager at Organon. “Vials and stoppers are sterilized and fed into a filling/stoppering machine where the vials are aseptically filled under laminar-flow HEPA-filtered air. In keeping with trends in the industry, we have located the filling/stoppering machine in an isolator that is operated via glove ports to minimize the potential for product contamination. This enclosure is sterilized using vaporized hydrogen peroxide and is then kept sterile during production by means of overpressured HEPA-filtered air. The use of hydrogen peroxide to sterilize the depyrogenation tunnel, as well as the filling/stoppering machine enclosure, results in the vials being transported through a sterilized environment from the time they are depyrogenated until after stoppering.”

Prior to filling, the product is sterilized using sterile filtration. Since there is no exposure to heat, the product isn’t damaged. The net result is that a sterile product is loaded into a sterile package in a sterilized environment, which is what aseptic packaging is all about.

One-stop shopping

To install such a line, Organon tapped the Italian firm IMA, represented in the U.S. by IMA North America (Fairfield, CT). The equipment was in place by late ’98. Approval from the necessary European authorities came late this summer, and shipment of vials was just getting underway as Packaging World went to press.

The equipment on the filling line consists of the following:

• vial washing machine

• depyrogenation tunnel

Is your palletizing solution leaving money on the floor?
Discover which palletizing technology—robotic, conventional, or hybrid—will maximize your packaging line efficiency while minimizing long-term costs in this comprehensive analysis.
Read More
Is your palletizing solution leaving money on the floor?
2024 PACK EXPO Innovations Reports
Exclusive access: Packaging World editor-curated reports revealing PACK EXPO's most groundbreaking technologies across food, healthcare, and machinery sectors. Each report features truly innovative solutions selected from hundreds of exhibitors by our expert team. Transform your operations with just one click.
Access Now
2024 PACK EXPO Innovations Reports