Strength through Packaging Support

By Daphne Allen

The Skelite synthetic resorbable bone graft substitute is supplied in a small header bag.

The strength of Millenium Biologix Corp. rests in its products. Literally. The manufacturer of synthetic bone graft products and other tissue engineering products offers Skelite, a porous ceramic biomaterial made from calcium phosphate that can speed natural healing. Supplied in granules and blocks, Skelite is designed to fill voids or gaps in bones or for spine fusion.

Based in Kingston, ON, Canada, Millenium is focusing on building its product portfolio and on expanding applications, which have even included space research. Packaging, therefore, isn’t the company’s main focus. “We don’t have a lot of in-house packaging expertise,” says Jason Hendry, director of biomaterials development. “We struggled with packaging.” Millenium wanted to develop packaging that orthopedic surgeons wouldn’t struggle with, and the firm wanted to perform all necessary evaluations to ensure package integrity. The company’s volume, however, is not high—it currently buys about 10,000 header bags per year.

Skelite is supplied in 20- and 30-ml glass bottles with vented caps and open-cell-foam plugs. “Most of the market uses bottles for these types of products, and they are easy to pour,” says Hendry. Because the bottles are used during surgery, they need a second package that can present the bottle in a sterile manner.

Since gamma radiation yellows the bright-white graft material, Millenium uses EtO sterilization to terminally sterilize them. Porous packaging to work in conjunction with the vented caps was in order.

Millenium applies a label to the back of the header bag.

Beacon Converters (Saddle Brook, NJ) provided 4 × 8 in. header bags with a 4-in. Tyvek header to hold the 20- and 30-ml bottles, the smallest header bag Beacon has ever provided. The bottles are held in place within the bag with a fold-over paperboard card insert whose die-cut center allows users to read the bottle’s label through the bag from both sides. “We tried using pouches, but the bottle’s original square shape didn’t fit into the pouch,” says Hendry. “We have since changed the bottle to a round cylinder, because doctors struggled with the square bottle’s opening, but the header bag is still easier to put into a carton with a bottle inside.”

A robust 5-mil poly/Surlyn/poly is used for the bag, but this wasn’t always the case. “We started off with a thinner material, which worked when packaging our 20-ml bottle,” says Hendry. “But when used for our 30-ml bottle, we encountered pinholes when the material fatigued during vibration testing.” Jackie Daly Johnson, president of Beacon, helped identify a material with better performance, Hendry says.

AppTec Laboratory Services (St. Paul, MN) performed much of the testing work.

Beacon was printing in black and purple ink on the coated Tyvek 1073B header, but Millenium has since switched to applying a label in-house to the bag itself.
Hendry appreciates Beacon’s support. “Marci Newman, our representative, supplied a lot of header bag samples to help us see whether they would work with our bottles,” he says. “Since we didn’t know a lot about packaging, it was helpful to have Beacon.”

Hendry advises other firms with a similar lack of packaging expertise to finalize package designs with the end-user before they invest in packaging and start to validate those designs.