CASE STUDY: 4SS Packaging Solutions

Quidel Corporation is an international leader in rapid diagnostic test devices. Headquartered in San Diego, California, their QuickVue products are distributed worldwide.

The challenge

Quidel's range of sophisticated diagnostics is highly moisture-sensitive, and requires a perfect seal. The slightest imperfection in package seals can allow moisture to invade, which makes the viewable test strips within the cassette housing unusable.

Quidel was looking for a four side seal machine that met the requirements of high-level of seal integrity, validatable sealing parameters and quick product changeover.

Doyen's Solution

Doyen's 4SS pouch sealers have cut changeover time from one pouch size to another by over five hours per change, drastically reducing packaging material waste, downtime and eliminating the risk of moisture transmission to the pouched test device. Over the past 10 years, Doyen has provided three of its Four Side Seal Packaging Machines to Quidel Corporation.

Feedback

(as published in Packaging Digest, Cahners Business Information, August 1999)

Quidel's Jay Strandberg, Material Specialist and Warehouse Group Leader, explains that the Food and Drug Administration currently requires these non invasive products to have 100-percent validatable package seals or validated packaging equipment. "Because the four-side sealer can validate seal integrity, we're ensured the pouch seals out moisture."

"These are vast improvements from the past", Strandberg says. "Our former equipment took between two and six hours to change over from one package size to the next." "Considering the many package stock stockpilings, this cost the firm plenty in downtime." "Today, we save days' worth of downtime," Strandberg says.

In some cases, Quidel's machines could be changed over as often as three or four times a day depending on schedules and on what was being changed. "We've regained much of that downtime capacity," Strandberg continues. "Now it takes seconds to call up something in memory."

There were other equipment choices available, Strandberg tells PD. "We looked at form / fill / seal equipment and tested some other flow wrap machinery with our pouches. The test pouches leaked or didn't prevent adequate moisture vapor transmission. One reason we chose the 4SS machine was that it was the only one that could hold the seal integrity we were after." "Maintaining the 18- to 24- month shelf life of the kits, the pouches prevent almost all moisture penetration." "We haven't had a 'leaker' with this machine," Strandberg adds. "We're very impressed because of the high degree of validation the machine provides. It can validate all sealing parameters. The seal integrity is vastly improved on these packages."

Building new strategies, Quidel is poised to take advantage of trends in healthcare management, such as more rapid in vitro diagnostics products for decentralized point-of-care sectors. Additional packaging equipment will be needed soon, Strandberg says, prompted by increased sales and a mission to improve performance of existing operations. "We have much to consider first, but every time we need something, Doyen can customize it for our needs."

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