Seeking to provide a large amount of wound care gel for burn surgery, B. Braun Medical AG (Germany) needed larger containers for its Prontosan Wound Gel in addition to the already available 30-g plastic ampoules. The sterile, highly viscous gel is now available in 250-g tubes, thanks to Neopac (www.neopac.com).
To meet the product’s sterilization requirements, Neopac and B. Braun Germany worked together to identify appropriate tube materials. Neopac’s Pharma Sales Manager, Chris Kipf, coordinated the project to fruition.
“It was a requirement that tubes be terminally sterilized at 121°C,” Richard Misdom, sales manager, Pharma North America, Neopac US Inc., told Tube News.
|The Polyfoil tube
features a proprietary molded orifice that is opened by inverting the cap and using it as a tool to open the tube.
Neopac and B. Braun Germany ultimately determined that a polypropylene Polyfoil Tube would suffice because the material can withstand exposure to an extreme temperature of 125° C.
Misdom explains that Neopac’s “PP Polyfoil tube is a proprietary laminate that has the PP used as the outside and sealant layer with foil in between.
“The Polyfoil tube chosen was our Topstar design,” he continues. “It has a proprietary molded orifice that is opened by inverting the cap and using it as a tool to open the tube.”
Polyfoil tubes from Neopac also offer barrier to organic and chemical substances and protect formulations against excess moisture or oxygen.
The tubes are also designed to maintain their shape, minimizing the amount of air drawn into the tube during dispensing. As a result, the contamination risk is reduced, the company reports.
The Polyfoil tube is offset printed in the round and covered by a special lacquer, Misdom adds.
Misdom explains that the “product is used primarily in the hospital, and I understand it is to be classified as a device.”
Ruedi Hofstetter, head of packaging technology at B. Braun Medical AG (Germany), said in a statement that “the requirements for a Class III medical device are stringently regulated by the Swiss decree governing Medical Devices. Neopac not only supported us in drafting the registration documentation, but also met our flexible delivery dates.”
Neopac produces its pharmaceutical tubes in fully certified cleanrooms and monitors for particles and microbes. It primarily manufactures high-barrier tubes (Polyfoil tubes) for the pharma, dental, and high-end cosmetic