Guaranteeing your medical device will stay sterile in a package that survives transit and storage is an essential step in earning clearance to go to market. But designing and validating sterile barrier packaging can be just as beastly as the development of a product itself.
And, it’s very expensive.
A common impulse is to try to go it alone and avoid a seemingly steep cost.
The thing is, it’s expensive whether you do it on your own or alongside a partner. And given the many technical challenges that can take developers by surprise, there’s a significant risk that that cost goes straight from your pocket down the drain if your package can’t be validated (not to mention the months of work wasted). If you’re under pressure to get a product cleared for commercialization — and you have a deadline looming — the best risk management play you can make is to find an experienced packaging and sterilization partner.
Setting the record straight on “pre-validated packaging”
You’ve probably heard contract manufacturers push “pre-validated packaging” in a promise to speed you on to commercialization.
It sounds great, but they’re not telling you what they really mean when they use the phrase.
To help explain, let’s walk through the testing requirements you need to meet for sterile barrier packaging to be validated:
- You must demonstrate that the packaging process results in an adequate seal
- Transit testing must show that the seal won’t fail when products are shipped
- Shelf-life testing must prove the integrity of the sterile seal will be maintained for a specified period
However, most pre-validated packaging is off-the-shelf. It’s billed as a time saver — and sometimes it is — but only for products that are conveniently compatible with the package specs.
Will someone’s pre-validated package account for your product’s unique design or material characteristics? When they say their package is pre-validated, they need to include a big asterisk and this disclaimer: “It’s pre-validated for these materials and this design, and if your product can’t fit within these constraints, you’re out of luck.”
What’s more, these providers have only done partial pre-validation. They may advertise a pre-validated package, but what they mean is: “The package is validated. The seal is not. You still have to do the transit tests to show that the seals won’t fail.”
In other words, most providers’ version of pre-validated packaging is incomplete and inflexible. It forces many medical device companies into an awkward compromise and shuts others out altogether.
It shouldn’t be that way.
J-Pac Medical approaches it differently. We pre-validate seals, not packages. This means that we can customize all the other package characteristics in service of your product with the assurance that its seal will remain intact in transit and the product will enjoy a shelf life of three to five years.
If your product is a good candidate for what we call “custom pre-validation,” you can expect to shave up to a month off your time to launch.
Don’t let package design hamper sterilization
We often proclaim the importance of designing for manufacturability. Those principles apply to sterilization, too.
It’s important to assess early in development whether the way your device package is designed could cause problems during sterilization.
You or your provider must ask these questions as soon as is feasible:
- How big is the sterilization chamber and how many products will be sterilized at once?
- How tightly can the products be packed?
- How many total layers must ethylene oxide penetrate to adequately sterilize a product?
- How much of each package’s surface area is exposed during a sterilization cycle?
- Do the packages overlap or double up on themselves by design?
The answers matter.
For one example, products packed too tightly can reduce the effectiveness of sterilization cycles because not enough surface area is exposed.
For another, the efficiency of ethylene oxide sterilization diminishes with every permeable layer it must pass through before reaching a device. Overlapping package layers or complex designs that double over on themselves won’t be as effectively sterilized.
Furthermore, cardboard boxes trap a lot of ethylene oxide. If it’s feasible, leave the boxing until after sterilization.
Finally, even the size and design of labels can impede the movement of ethylene oxide inside a package.
All these examples can lead sterilizers to compensate by increasing cycle time, ramping up chamber pressure or both.
Aside from being a hidden cost driver and timeline killer, overuse of ethylene oxide — a known carcinogen — is the opposite of what regulators or the industry want.
Know your sterilizing options based on program volume and timeline
One size never fits all. Your product characteristics and production volume requirements will determine which approach is best.
But here’s a critical wrinkle: There exists a shortage of sterilization capacity across the country owing to the shutdown of a number of large sterilization facilities across the country. These facilities were found to emit far more ethylene oxide than revised federal rules allowed. Some operators chose not to come back online, citing the high cost of scrubbing equipment.
These capacity constraints will persist indefinitely. Medical device developers caught unaware risk wasting precious time just by waiting in line.
Engage an outsourcing partner sooner rather than later. They’ll consider your product and program characteristics in relation to the dynamics listed below to determine the sterilization regiment that makes the most sense.
High-volume sterilization – If your products are small enough, you can effectively sterilize them at the scale you need without securing the services of a larger-scale sterilizer. You can still expect a production rate of up to 10 pallets a week from a provider with fewer or smaller chambers if your products themselves are small. However, if your products are larger, you’ll need those bigger chambers to achieve efficient sterilization at high volume. The sooner you can solidify this plan, the closer to the front of the line you’ll be.
Medium-volume sterilization – Beware of tradeoffs. Whether you sterilize in larger chambers or smaller ones will depend on the size of your products, production rate requirements and a comparison of costs over time. Lean on your outsourcing partner to help make the right call.
Low-volume sterilization – If you only need to meet a production rate of less than one to three pallets per month, a smaller-scale provider is the better bet. For one thing, running low-volume production through a high-volume provider’s equipment will be costly. For another, the larger-scale sterilizers make their margins on efficient sterilization of lots of products. If you’re running a low volume, they might not even let you in the door.
J-Pac Medical manages sterilization with third-party partners for most high-volume programs. In doing so, we’ve established working relationships with every major sterilization provider in the country, allowing us to more quickly locate and engage the suppliers that have available capacity when you need it.
But for lower-volume runs, it is often faster and less costly overall for us to EO sterilize right here at J-Pac. We currently support sterilization in our facilities for low-volume work or high-volume, small-size programs. But those capabilities are expanding as we speak with the addition of more and bigger in-house sterilization equipment.
Will your label stand up to sterilization and transit?
Problems with labels are the leading cause of medical device recalls. Those who have had the misfortune of sustaining such a setback know how costly and demoralizing it can be.
“Label problems” can manifest in a variety of ways:
- Information on the label was inaccurate
- The design or content of a label didn’t meet strict regulatory guidelines
- The label doesn’t stick to a package as it should
- Information on the label is illegible
In our experience, medical device developers and the consultants they sometimes retain pay much closer attention to the first two items above than the third or fourth.
But those later problems can sink a program just as quickly; and most of the time, they emerge during sterilization.
Let’s talk about label adhesion first. While it’s obviously important to choose a label adhesive that adequately sticks to your package under normal conditions, consider that the adhesive must also survive the sterilization environment.
For example, a mismatch between a label adhesive and packaging material in a pressurized ethylene oxide sterilization chamber can result in an un-sticking of what you hope stays stuck.
With regard to legibility, ethylene oxide’s solvent properties can also degrade some inks.
Some label adhesives and printed ink are also sensitive to vibration.
Obviously, a device with a label you can’t read (or which is missing one entirely) becomes a product you can’t sell.
Over the years, J-Pac Medical has developed a deep technical expertise where packaging materials, adhesives and labels intersect. Our team knows the problems that can emerge and is well-versed in developing pre-tests to determine in advance if your product’s packaging and sterilization process can be validated.
It’s good risk management and a potentially huge cost savings if we can catch and correct problems internally prior to formal validation.
You get the guidance you pay for
By the time your medical device program reaches the packaging and sterilization validation stage, you’re seeing light at the end of the tunnel.
But the cost of getting that far only to fail is devastating. A recall is even worse.
Exploring a partnership with J-Pac Medical is the first step in making sure none of that happens.