On a roll

A packaging machine that uses rolled pouches helps a medical device manufacturer completely solve all major requirements for lower-volume production.

Larry Smith suspects that he faces the same challenges that many other medical device manufacturers face. As director of manufacturing for Nexus Medical (Lenexa, KS), Smith says that “our largest packaging problem, like that of many medical manufacturers, is that we build a large number of similar but different codes in small to medium volumes, such as 1000 to 30,000 units per production run.”

Because of such varying production lots, Smith says he “needs equipment that is extremely fast and accurate to change over from product code to product code.” The firm manufactures specialty IV administration sets and extension sets. This is a growing market; according to BCC Research (Norwalk, CT), the U.S. market for IV therapy and vein access products was worth more than $3.2 billion in 2005 and will reach almost $3.8 billion by 2010.

Nexus Medical had been using standard heat sealers and Tyvek pouches for many products as well as form-fill-seal machinery for others. “Normal Tyvek sealers provide fast and reliable pouch sealing, but offer no assistance for filling and the limited ability to print high-quality variables on-line, such as product description, product code, and lot code.”

Also, form-fill-seal is “fantastic in every way for high-volume production,” says Smith, but he has found that it “generally takes 1–2 hours of changeover time between codes, so it is not best suited for the smaller production runs.”

Smith describes his firm’s basic packaging requirements for equipment as follows:
 
• Efficient and ergonomic filling.

• Ability to print variables on packaging in a high-quality manner.

• Consistent seals for a validatable sterile barrier.

• Fast, trouble-free changeover from one product or pouch size to another.

• Bulletproof reliability.

• Cost-effective and easy-to-obtain machinery, packaging materials, and inks.

• Cleanroom design that generates no particulates or contaminants and that is easy to clean and maintain.

While walking the Medical Design & Manufacturing West 2005 show in Anaheim, CA, Smith and his team discovered a packaging machine by PurePouch (Ham Lake, MN) in a little basement booth. “We were amazed at how simple and how well the unit operated,” says Smith. After careful evaluation during a visit to the PurePouch factory, Nexus discovered that “PurePouch met our requirements better than any other technology for our small- to medium-sized production runs,” Smith says. “PurePouch is an excellent solution for companies that do production runs of sterile products with volumes that do not warrant full form-fill-seal production.”

PurePouch uses chevron pouches supplied by the material converter in a continuous, nonperforated roll. These pouches can range in size from as small as 2 × 2 in. to as large as more than 10 × 12 in. According to Bill Doty, president, PurePouch worked closely with Tolas Healthcare Packaging (Feasterville, PA) during machine design. “Given Tolas’s knowledge of package validation requirements, they were able to provide design input,” he says.

The Pouches on a Roll that Nexus purchases from Tolas are fabricated of Tyvek 1059B sealed to TPF-0506, a sealant film lamination. The sealant layer of this film lamination when sealed to a lighter-weight Tyvek provides higher minimum peel values and evidence of seal integrity than that of standard grades of PET/LDPE when sealed to the same grades of Tyvek.

The rolled pouches are fed into the PurePouch system, which first prints the labeling and then slits the top layer of the pouch. The web advances, and the machine opens the pouch for easy product insertion. The web advances again to seal the pouch and cut it from the remaining web of pouches.

Nexus Medical decided to purchase pouching material from Tolas. “They had worked with PurePouch during product development and knew exactly what was required,” says Smith. “Tolas was a new vendor for us, and we found them to be excited about the PurePouch technology and extremely helpful in filling our pouch needs with minimum effort on our part.” In addition, Smith found Tolas’s pouches priced competitively as compared with other vendors and with standard nonrolled pouches.

IQ/OQ/PQ went well, reports Smith. “PurePouch provided training for our staff in its facility on our machine and covered every aspect of the unit’s operation. This allowed us to operate our machine there for several hours and then have them make the few small adjustments that we felt were needed prior to shipment to our facility.” 

Once at the Nexus Medical facility, the PurePouch system went through smooth installation qualification and operational qualification. “They went very quickly with no problems at all,” says Smith. “We then performed an intensive performance qualification, where we validated the sterile barrier integrity just as we would for any new pouch sealer.” Because a PLC directs the PurePouch, “nice outputs for pressure, seal time, and temperature are provided on the control panel that aid in validation and verification of machine settings.”

In addition, because PurePouch is so basic in overall function, says Smith, preparing the protocol was pretty straightforward.

The only problem Nexus experienced was at start-up with printer programming. “We had trouble in getting the printer drivers in Label View, our label software program, to correctly communicate with the EasyPrint thermal-transfer printer from Bell-Mark Sales Corp. [Pine Brook, NJ]. After a little bit of frustration, we contacted both PurePouch and Bell-Mark and discovered that the Label View drivers in Rev 7.0 were incorrect and that we needed to upgrade to the just-released Label View 8.0. Doing so completely corrected the problem.”

Smith says that Nexus typically partners with each of its vendors to help them improve their product lines, which ends up benefiting Nexus, too. This project was no exception. “Since receiving our PurePouch we have worked very closely with the manufacturer to suggest ways to make PurePouch even better,” Smith says. Nexus’s first suggestion was to reduce the noise from vacuum system. “At our suggestion, PurePouch engineered a good solution within a month and shipped us an update kit for our machine. Our second, more-difficult-to-accomplish suggestion was to find a way to increase machine output speed without compromising seal integrity.”

PurePouch is devising a simple two-up pouch configuration that will not significantly change the machine but will double the output rate, Smith reports. PurePouch hopes to have the first unit of this configuration available at the upcoming Medical Design & Manufacturing Minneapolis show October 24–26.