MedChem Products has proven that sometimes you can have your cake and eat it too. The Woburn MA-based maker of medical devices has repackaged Avitene MCH a microfibrillar collagen hemostat in a flexible stand-up pouch that withstands sterilization yet still permits easy opening by nurses in a surgical OR. Inside the pouch is the new primary package a sealed cup.
The pouch is just now beginning to replace a rigid package system that wasn't exactly user-friendly. Avitene was filled into a glass jar with a screw cap. This primary container was then packed into a spiral-wound paperboard can with a shrink band seal.
The reason for the hefty packaging is the product's sensitivity to moisture. "Avitene is dried to low moisture content after our primary packaging operation and is immediately sealed into pouches of high-barrier film" explains Ozzie Chu product development engineer at MedChem a subsidiary of C.R. Bard. The high-moisture-barrier film assures that the product's moisture content remains within tolerance. The dried product is immediately ready to use says Chu. That's why Avitene is the only hemostatic product specified for neurosurgery and emergency arterial bleeding.
In addition the packaging must be robust to withstand MedChem's dry-heat sterilization at temperatures above 120°C for more than 20 hours. The new package includes a polycarbonate cup sealed with a peelable lid of DuPont's Tyvek®. The cup is then packed inside the pre-made stand-up pouch that is sealed and sterilized.
The pouch material is a laminate of reverse-printed 48-ga polyester/1-mil aluminum foil/proprietary 2-mil peelable sealant layer. It's supplied by Rollprint Packaging Products (Addison IL) and is fabricated into the stand-up pouch by Kapak Corp. (Minneapolis MN).
One well-recognized benefit of the stand-up-pouch is source reduction. For hospitals that use Avitene source reduction is quickly translated into waste reduction. The new package boasts a weight reduction of 80% compared to the previous pack. This results not only in reducing waste but in decreased shipping costs and unit package costs.
This source reduction so impressed judges in the Flexible Packaging Assn. competition the package was awarded the '95 Green Globe award for being most environmentally sound among the winners. But it was user convenience that helped it garner an FPA Top Packaging Award.
How it's used
MedChem's new package is fast and easy for operating room nurses to peel open. "Our marketing staff routinely visits operating rooms and discusses product use with OR nurses and doctors" says Michael McCartin product manager for hemostasis at MedChem.
"We realized three years ago that we needed to improve upon the original Avitene package which was introduced with the product over 20 years ago. The nurses in OR all wear gloves and packages that can be easily peeled open are demanded by the industry."
Avitene is a topical hemostatic agent used in the OR in critical situations to help control bleeding. The product needs to move from the surgical shelf through the sterile field without being contaminated and into the hands of the doctor as quickly as possible. "Designing a package that could be quickly and easily opened and passed into the sterile field while conforming to sterile techniques in the OR were major concerns" notes McCartin.
Rollprint's proprietary sealant layer is credited for simultaneously maintaining seal integrity and easy peelability after the punishing process of heat sterilization. The stand-up pouch is sealed with a chevron seal that offers excess material above the seal so nurses wearing gloves can easily grip the package and peel the top open.
"Trials show the new Avitene package can be opened in about one-quarter of the time it took to open the original Avitene package" says McCartin. MedChem customers in Japan will receive the new Avitene package in June 1996 and domestic customers will soon begin receiving shipments.
Rollprint's lamination provides moisture barrier properties that allow the topical hemostatic agent to remain unaffected even during the lengthy shipping process to Japan where MedChem sells a significant volume of its product.
"We're not concerned about our export product quality upon arrival because the barrier quality of the package can withstand the warm and moisture-rich shipping environment" adds Chu. According to Rollprint president Bob Doddrill the 1-mil aluminum foil provides barrier properties nearly equivalent to a metal can. The sealant layer a multiple-ply extrusion creates hermetic seals. Test results on the lamination measure moisture or gas transmission rates out to the fourth or fifth decimal place.
The stand-up-pouch is well suited to MedChem's heat sterilization process because of the extra volume inherent in the package. The gusseted bottom allows for air expansion while seal integrity is maintained. A PC cup holding 1 g of Avitene is packaged into a stand-up-pouch measuring 6" square with a 3" gusset.
"If we had used a flat two-sided pouch we would have needed a larger pouch and a partial vacuum would have been necessary prior to sealing" says Chu. "A flat pouch for one gram of Avitene would have measured approximately seven by eight inches. Besides requiring more material and an additional packaging process a flat pouch would have been prone to wrinkling which makes it difficult to top seal."
Standing up to use
Another well-recognized benefit of the stand-up pouch is its shelf presence. While this feature is usually associated with consumer markets the nurses doctors and patients at hospitals using the new Avitene package also benefit. "The stand-up pouch is easily visible on the shelf in the OR" notes McCartin. "Fast identification of our product contributes to the speed with which nurses can move the product off the shelf and into the doctor's hands." That's especially critical for a product that's most often used when a patient is bleeding to excess.
"At first we used the OR nurses with whom we are in regular contact as package design consultants; they told us what they needed" continues McCartin. MedChem then approached Rollprint with its new package concept. The two companies had worked together for three years producing a variety of flat pouches used to package other MedChem products. Thus Rollprint had experience making films that could withstand heat sterilization temperatures in excess of 120°C and remain peelable.
"Our goal during the design of the new Avitene package was to use the same film from Rollprint that we had had good experience with" notes Chu. "Rollprint was very creative. We gave them a pouch design and they gave us the right material to put it together."
Product quality is a major objective for MedChem; its production processes are designed to support that goal. MedChem audits suppliers prior to purchasing material and then schedules routine audits annually. Additionally incoming material is inspected by its QC personnel. For competitive reasons MedChem declines to identify the equipment it uses to fill and lid the PC cup and the sealing system used to seal the pre-made pouches.
"One of the reasons we chose Rollprint as a supplier was their experience in the medical packaging industry" explained Mr. Chu. "They're very familiar with our requirements because they understand clean room requirements." Rollprint operates its two plants under CGMPs and is registered as a medical device manufacturing facility. That subjects them to the same rigorous standards applied to medical manufacturers like MedChem.
"The perioperative nurses we work with have looked at the prototypes we've developed along the way and they've offered us feedback" McCartin concludes. "The fact that they're thrilled with the new package is no surprise to us."