Your medical device packaging design and related equipment are validated. Can you live with a hurried decision for the next 10 years?
John Abraham, Atlas Vac Machine
The packaging engineer is too often invited “late to the party” when a new medical device is being launched. The device packaging design process is no time for shortcuts or missing critical details. The potential failure of the packaging is just as critical as the numerous potential deficiencies that can cause a device failure. Similar issues can arise when transferring a product to an outsourced supplier where duplication of an existing packaging protocol is too easily assumed.
Package design considerations
If the new rigid package design is based on familiar materials and sources, the packaging engineer will likely know what to expect for performance and timeline. If the project requires a new material type, a thinner material, a unique design feature or a different testing protocol, it would be best to understand the risks introduced and any impact on the timeline.
Is it wise to have a Plan B if Plan A is too nuanced? Asymmetrical features and depth variations will cause tray wall thickness as well as sealing flange thickness to vary. This is normal for thermoformed packaging. There are numerous opinions about what the correct sealing flange width should be. If it was a simple precise calculation, why do we see so many design variations? Likewise, the testing methods for that seal are based on closely held viewpoints. Are there better methods available or is the current one providing reliable data from all responsible parties in the packaging process?
An often-overlooked issue is existing cleanroom equipment capacity. Has the packaging engineer engaged operations to understand why (or why not) the needed equipment and capacity are on hand? If not, it would be easy to procure a duplicate piece of equipment unless the original is too old, not up to current safety standards, lacking in features that may solve existing operational issues, not data-enabled, not sustainable, or lacking a record of reliability under hard use. Consider reviewing the equipment and options available from reliable suppliers who offer a long-term solution. Get into the technical details. Also, attempting a custom equipment design adds risk to the timeline, so buying “off the rack” may be advised.
This ISO requirement is typically not thought of until the new packaging equipment is delivered. Training at the OEM factory can offer numerous advantages. Something as simple as reviewing an installation qualification (IQ) checklist and the related equipment features can save hours of backtracking should someone who is uninformed install the equipment incorrectly.
Having an initial hands-on familiarity with the controls system in a relaxed environment without clean room gowning can increase the proficiency of the packaging engineer and perhaps their ability to conduct the upcoming operational qualification (OQ) with confidence. A hand-in-hand review of the equipment manual is essential to provide the packaging engineer with the ability to train others (maintenance, calibration, operators) as well as to find IQ data recommended by the OEM.
Staff members who provide in-house calibration need to be familiar with the new equipment and would benefit from a factory visit to explore the OEM calibration approach vs. any assumed “tried & true” methods. Too often, incorrect calibration of the new equipment leads a product launch down a dead end.
The packaging engineer should be involved in the project timeline earlier than typically permitted if these decisions are to be made with vetted confidence. Once validated, the packaging design and equipment will be something to be lived with over the lifecycle of the medical device.
John Abraham, president of Atlas Vac Machine, is an engineer and MBA with 18 years experience in medical device packaging as well as 20+ years in aerospace, military and heavy industrial products. Atlas Vac’s core expertise is capital equipment for medical device cleanroom packaging.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.