For many in medical packaging, 2020 was a year of pandemic pivots that forced changes to packaging lines and tested the agility of medical device makers, packagers, and equipment vendors alike.
A successful case from the contract packaging space features BD (Becton, Dickinson and Co.) and its Veritor System for Rapid Detection of SARS-CoV-2 virus, which is an antigen test kit for COVID-19. BD announced in July 2020 that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA) for the test kit.
Earlier in 2020, with the EUA expected and a summer launch in the works, BD had approached Web Industries to manufacture and package the kit. Web was well positioned to take on the project, having made a significant investment in biochemistry and medical device manufacturing a few years prior.
In mid-April 2020, Web contacted Campbell Wrapper to buy horizontal wrappers for the new test kit lines. Web took delivery of the first machine, a Campbell Revolution Flow Wrapper, eight weeks later. The timing is noteworthy, considering delivery would normally take five months.
A month after delivery of the first machine, Web asked Campbell for a second wrapper, same model. Speedy delivery was once again of the essence, and Campbell produced that wrapper in just four weeks. By the end of 2020, Web was running four BD Veritor COVID-19 test kit lines; a fifth was installed in early 2021. All five lines feature the Campbell horizontal flow wrapper.
Web chose that model for its test kit lines “based on appropriateness to package the test device,” as well as the equipment’s capacity, says Kevin Young, VP of corporate development and medical for Web Industries.
BD also manufactures the Veritor COVID-19 test kit at its own plants. Production by BD and Web combined was 8 million per month at the launch of the COVID-19 test kit in July 2020; combined production volume has now grown to 12 million per month. For comparison, BD’s production of flu tests is normally 8 to 10 million per year.
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Each COVID-19 test kit includes nasal swabs, processing tubes containing liquid reagent, and test devices. To evaluate a sample, users insert the test device into a BD Veritor Plus Analyzer. Test results appear on the analyzer’s digital display in 15 minutes.
Before the pandemic, BD’s handheld analyzer was used in point-of-care settings to test patients for the flu and other respiratory infections. The device is appropriate for COVID-19 testing in a range of environments, including pharmacies, nursing homes, schools, and doctors’ offices.
Young, together with Graham Nice, regional sales manager at Campbell Wrapper, answer questions from Packaging Digest about this challenging and ultimately rewarding project.
What is Web Industries using the wrappers to package?
Young: Web is using a foil material to pouch an assembled test device. Rolls of metallized foil are received and run through the Campbell flow wrapper. Basically, this is a form-fill-seal process in which the foil is printed with the specific lot, date, and other information; formed into a pouch that the test device is inserted into, along with a desiccant pack; and then sealed.
Is Web also manufacturing the test device?
Young: Web does manufacture the device. We receive the chemistry from the OEM and laminate it onto a proprietary backing sheet. We create master rolls and then, using proprietary equipment, cut and place precise lateral flow assay strips into a bottom cassette. A top cassette is applied to fully encapsulate the lateral flow assay strip. These test devices are then run through the flow wrapper to be pouched, as described above.
What items are included in the kit and how? For example, are there partitions in the carton or are the individually wrapped items loose in the carton?
Young: Kitting involves a number of discrete steps. There are separators that allow for 30 individualized test devices to reside in a kit. Also included are 30 nasal swabs, individually packaged; 30 buffer extraction reagent tubes and tip assemblies, in three packages of 10; individually packaged positive and negative control swabs; and a buffer solution tray.
Where are these kits being distributed?
Young: We ship them directly to the OEM’s warehouse, and they’re distributed to nursing homes, government agencies, schools, and distributors.
How many test kits is Web producing now?
Young: Web is now capable of producing more than 2.1 million test devices per week.
Is the production of test kits slowing down, speeding up, or staying about the same now?
Young: There is a fundamental shift taking place in the market. Demand is shifting from point-of-care (POC) test devices to at-home tests (AHT), some requiring a prescription, and some that are over-the-counter and available at a pharmacy.
The anticipated volume of AHT is expected to exceed the amount of POC tests due to the convenience to perform the test at home. Think of the evolution of pregnancy tests that once were administered at a doctor’s office or clinic, but now are readily available at a pharmacy without a prescription for at-home use.
How was Campbell able to meet the expedited deliveries?
Nice: During the pandemic, and especially as COVID-related machines were in process, Campbell employees responded with pride and worked extensive overtime — two shifts, seven days a week — to do their part to expedite shipment of machines and help the country get beyond the crisis.
Campbell relied on long-term vendor partners and new suppliers to support the effort for improvement in lead time of components. As our employees did, our vendors responded with a strong sense of pride in being able to “be part of the solution.”
For more than 70 years, Campbell Wrapper has designed and manufactured quality horizontal flow wrappers and feeding equipment for the chocolate, confectionery, food, medical, personal care, household product, wet-wipe, and paper industries. As we prioritized the urgent COVID-related projects, when it was necessary to ask our loyal non-COVID-related customers for lead time relief on their pre-pandemic orders, our customers responded with understanding and appreciation for what we were doing.
This understanding of our customers allowed us to use parts that were already manufactured and some subassemblies from their machines for the urgent COVID-related projects.