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With state-of-the-art facilities in Somersworth, New Hampshire and Costa Rica, J-Pac Medical supports 70,000 total square feet of dedicated medical device manufacturing, assembly and packaging space.

We help innovative medical and molecular diagnostics companies speed time-to-market and scale up manufacturing for the long term.

Understanding Medical Device Packaging: Podcast

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J-Pac Medical CEO, Jeff Barrett, discusses medical device design, packaging and sterilization validation on SPOT Radio with host Charlie Webb. Understanding ISO 11607 allows contract packagers to avoid failures due to packaging system design, feasibility testing and packaging system as a whole.

A medical device protective packaging system comprised of sealed thermoformed trays packaged in shelf containers

Role of Small Chamber Eto Sterilizers in Medical Device Processing

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3M steri-vac GS8X

The Eto Sterilization Industry has long been predicated on the premise that larger is better. The industry as it is today is based on chamber capacities based on pallets of product, not units of product. As a result, with recent Eto Plant closures, large amounts of capacity have quickly disappeared and placed in jeopardy the overall ability of the current Eto Facilities to handle the needed market volume of product.

These large chambers that handle pallet loads of medical products are largely inefficient. While the goal of performing the Eto Sterilization is to sterilize the sterile barrier system and contained medical product, the pallet load scenario requires that folding cartons, corrugated cases and even the pallets themselves to be included in the sterilization load, creating unnecessary density that requires a longer overall cycle and more Eto Sterilant Gas to effect sterile processing.

Additionally, and especially in the current capacity constrained market, medical device companies seeking capacity will access any available chamber size in order to get needed products to market. This can result in small amounts of product being processed through chambers that are oversized for the load, requiring longer sterilization times and greater use of Eto Sterilant than should be required. This scenario is common with routinely sterilized smaller volume products, as well as new products.

Recent events have given rise to a need to complete medical device sterilization using appropriately sized chambers and a minimum of Eto Sterilant Gas in the process. Removal of unnecessary density from the load, and right sizing the load to the chamber are easily accomplished with some rethinking of historical preconditions.

A relatively new approach to meeting these objectives is available through the use of smaller chamber Eto Sterilizers. These sterilizers have been used for years in hospitals to sterilize devices and equipment on demand, and most recently are being used by OEM’s and Contract Service Houses to provide terminally sterilized sterile, disposable medical products. The use of these units is especially beneficial with small to mid-volume products where the sterilization can be performed in-process immediately following creation of the sterile barrier system, as opposed to at finished goods. With only the sterile barrier system and medical product being included in the sterilization cycle, the following benefits result:

  • Loads are a higher density containing only target materials (no folding cartons, IFU’s Corrugated Shippers or Pallets).
  • Cycles are shorter because of the reduced chamber size and focused density.
  • Eto Sterilant Density may be run at a lower level compared to the traditional finished goods sterilization approach.
  • In-process sterilization precludes the need for shipment of “non-sterile product that is labelled as sterile” to and from a contract facility.
  • Improved usage of sterilization capacity.

These small chamber sterilizers may not meet the needs for all products, but definitely offer advantages where product size and volumes avail themselves to the approach. Cycles typically range from 8-12 hours, and can easily be accommodated within a product as an intermediate step prior to secondary packaging. The production planning inclusive of sterilization becomes one focused on internal flow rather than building larger volumes of products to finished goods that are subsequently shipped off site for sterilization processing.

This scenario is especially advantageous in the processing of resorbable polymer products requiring barrier packaging post Eto processing. The “Open Time” between Eto Exposure and creation of the barrier package can be greatly reduced with in-process in-house sterilization compared to remote processing. The scenario also lends itself to the incorporation of past-Eto vacuum drying of the product followed in rapid succession by barrier packaging, an optimal approach to this type of packaging.

This is a different thought process than is typical for Eto Sterilization today, but one that can bring benefits in the capacity constrained Eto Market that we are dealing with today.

Validating Medical Device Assembly, Packaging, & Sterilization

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Prevalidated sterile package with urethane insert

According to the World Health Organization (WHO), healthcare-associated infections (HAIs) are the most frequent adverse event in the delivery of healthcare services worldwide. Ensuring the sterility of medical devices is a critical step in the overall effort to reduce the rate of infections in hospitals and other healthcare settings.

Medical device packaging and sterilization validation are required for FDA 510(k) submissions yet are often causes of delay. Sterile packaging validation is a vastly misunderstood topic in its own right but becomes even more complicated when considering it involves the additional coordination of manufacturing, product shelf life, and sterilization validations all under a complicated array of regulations. This white paper explains how these validation requirements must be coordinated for medical device manufacturers to get their single-use medical devices to market faster.

Key Regulations

Medical device OEMs typically work with three separate entities for the back-end stages of product realization: medical device outsourcing companies, testing labs, and sterilization companies. It is common for these entities to focus on their particular expertise without helping the OEM navigate the process as a whole.

The best way to think about the market launch requirements of sterilized, single-use medical devices is to think in terms of how these requirements work together.

1. Package Design

Package design is regulated by ISO 11607 (Part 1 and Part 2), and these standards are universally required by the FDA and the EU Medical Device Regulations. ISO 11607 is one of the most misunderstood standards in device development, requiring the execution of more than 25 specifications, protocols, and test reports.

protective packaging system diagram

The regulations require that sterile packaging be treated holistically as a Sterile Packaging System. A sterile packaging system is much more than a sterile barrier package; it is the combination of the sterile barrier system and external protective packaging required to deliver the device from manufacturing through sterilization, storage, distribution, and aseptic delivery to the sterile field. This requires a significant amount of design activities, verification, and validation. Most importantly, it requires a complete understanding of the stresses the package will endure throughout the distribution cycle.

ISO 11607-1 defines requirements for sterile barrier system materials selection and their design and testing. ISO 11607-2 defines manufacturing packaging process validation requirements for forming, sealing, and assembly processes. Too frequently, medical device manufacturers do not include assembly process validation as part of the equation.

Some of the critical steps of this standard include:

  • Developing packaging system requirements that specify the customer’s design needs for the sterile barrier and the protective packaging systemMedical device manufacturers must obtain customer feedback on the package ease-ofuse and gain a solid understanding of the storage, transportation, and shelf life requirements of the device. Other considerations include the requirements for the microbial barrier and evaluating possible interactions with the sterilization method on both the sterile barrier as well as the device itself.
  • Designing a sterile barrier . Examples of these include porous and nonporous pouches, header, patch bags, and thermoformed trays. The packaging solution is a direct result of the system requirements.
  • Designing protective packaging to ensure the device can survive transportation stresses from the point of manufacture to the customer. One of the most common causes of packaging failures is not considering how products are shipped to customers. For example, palletized products from the manufacturer must be tested to ensure they can be delivered through sterilization, but further testing is required if those pallets are broken down and the product is shipped to customers through common carriers. Having a box thrown into a UPS truck is not the same as shipping a skid from the manufacturer. One of the most common mistakes we see is not considering consolidated shipping configurations that are used for sterilization. Orthopedic implants, in particular, generate significant stresses on packaging and are highly sensitive to shipping configurations.
  • Package prototyping is recommended to ensure the final package will meet the needs of the customer and will be manufacturable and optimized for final assembly of the device. Selecting a contract manufacturer with internal thermoforming and a broad array of packaging technologies can provide companies with a realistic sample of the final package much faster than having to coordinate multiple suppliers.
  • Package verification testing is a critical step and is often overlooked, which increases the chance that the package fails the final transit test. In this step, the final version of the product is packaged and undergoes preliminary package testing to ensure it has a high probability of passing the final transit testing. Some labs report up to 30% of their medical device packages fail the ASTM or ISTA transit tests. A preliminary transit test greatly reduces this risk. Typical sterile package verification tests include peel testing and bubble leak testing. These tests must be validated in advance.
  • A sterile presentation test must be conducted with actual end-users to ensure the medical device can be aseptically presented. Scrub nurse and doctor interaction with the package is critical. Some packages can be designed to deliver the device to the sterile field by allowing the device to gently “fall” out of the package onto a sterile table. Other devices require the product to be held over the sterile field while the scrub nurse manually removes the device from the package. Each of these scenarios impacts the design of the package regarding ease of opening and, for thermoformed trays, how the package is designed to be held with one hand while peeling the lid with the other.

2. Validation of Forming, Sealing, and Package Assembly

The process used to assemble the package and seal the sterile barrier must be validated. Key steps include:

  • Developing a sampling plan that applies to the process being validated, based on a statistically valid rationale. ISO 2859-1 or ISO 186 are common references.
  • Using a validated test method and defining the criteria for acceptance.
  • Tooling design and fabrication. IQ (Installation Qualification) for forming and sealing equipment.
  • OQ (Operational Qualification) of the sealing process. This involves challenging the sealing process parameters to create windows of variability that the process must maintain to provide an acceptable seal. It is imperative that products produced for subsequent sterilization and transit testing be produced at OQ-Low to simulate worst-case manufacturing conditions. This is often overlooked and can yield compromised packaging during ongoing production when sealing parameters drift to the low end of their specification. This requirement ensures that a seal made under the worst-case process variation will stay intact.
  • PQ (Process Qualification). This step involves producing product under realworld manufacturing conditions including multiple shifts and operators. The fastest path of validation involves using OQ-Low to validate post-sterilization transit and seal stability testing and PQ for final sterilization validation

3. Manufacturing Process Validation

Validating the sealing process is just one element of the manufacturing validation, which must include all the cleanroom assembly steps to produce the device. A separate IQ, OQ, and PQ must be performed for the assembly process prior to sterilization validation. Conducting the production and assembly process validation in conjunction with package validation saves significant time.

4. Worst-Case Sterilization

Sterilization can put significant stresses on a package and also can impact the shelf life of the device. To reduce the risk of failure the medical device package must be exposed to worst-case sterilization prior to transit testing. “Worst-case” needs to be justified. A double (2X) sterilization is often used to simulate worst-case. A 2X sterilization cycle may occur when there is a sterilization cycle that needs to be aborted due to mechanical failure, or there is a need to re-label a previously sterilized product. Your contract manufacturer should coordinate a discussion with the sterilizer to determine the best assumptions.

5. Transit Testing

Transit testing has two objectives. The first is to evaluate if the product and package interaction during shipping will compromise either the sterile barrier or the product itself. The second is to determine if sterilization will impact the sterile barrier irrespective of the product interaction.

An ISTA or ASTM transit test should be selected that best reflects the actual transportation and storage environment that the package will experience. There are a variety of possible distribution cycles for transit simulation including air and motor freight. Test conditions include atmospheric conditioning (e.g., humidity, temperature), compression, vibration, and shock. Testing for both palletized movement and individual shipper handling are crucial considerations.

ISO 11607 requires proper documentation and a rationale for the use of a particular test along with detailed conditions under which the sterile barrier must be maintained.

6. Seal Testing

Always conduct seal tests with empty packages. This allows the sterilization effect on the package seal to be independently evaluated. There are many reported cases where package design has been changed unnecessarily because there was not independent testing of the seal. In essence, if the seal is not tested independently and the transit test fails, the customer will not know if the failure was caused by the seal design or the impact of the product. Costs are increased because tests must be repeated, and product is wasted. Similarly, testing full packages increases the volume of product that needs to be manufactured for the test.

Seal tests can involve several ASTM test methods with the most popular being the bubble leak test, visual seal inspection, and peel strength testing. These tests are performed after both accelerated and real-time stability testing. The FDA will accept accelerated shelf life testing as long as real-time testing is completed in parallel. The desired shelf life dramatically impacts the cost of the test due to the sample size and test time required.

Accelerated shelf life testing allows the product to be launched more quickly and can be critical to supporting clinical trials. A one-year shelf life label can be accomplished in just 46 days of accelerated aging; this is adequate for clinical testing. Two types of stability tests must occur: tests on the seal design and tests to ensure the packaged device does not negatively impact the seal. The medical device must also be tested to ensure its functionality is acceptable for each point of shelf life testing (1 yr., 2 yr., etc.).

7. Sterilization Validation

There are two main methods of validating medical device sterilization.

First is validating the desired load size for ongoing production. This method requires that the planned batch size be validated as a group. For example, a four-pallet Eto chamber process can be validated with four pallets of packaged product or a smaller amount of packaged product with dunnage that simulates the density of the larger load. This can be an impractical method for new product launches because it often requires more product to be produced than needed for initial market launch.

The second popular method is “single lot release.” This is accomplished by sterilizing three separate smaller lots of product and then performing a retrospective study to create a validated sterilization process. All three lots must be processed within one year. The single-lot release is a sterilization verification method — not a validation method — because each lot is tested to verify its sterility. This is often more expensive than validating a larger load but is often the most practical approach.

Sterilization validation should use manufactured product out of PQ so that it represents product produced under a validated manufacturing process. So, while package transit testing should use OQ-low to ensure the package protects under worst-case conditions, product from the sterilization validation should be validated using PQ production. This way customers can use the product undergoing sterilization validation.

Timing of the Complete Validation Process

Timing and costs can vary greatly depending on the medical device validation strategy deployed as well as how coordinated the individual processes are managed. Your medical device outsourcing partner should provide a detailed schedule of timing and costs for various scenarios. This timing must also be integrated into the higher-level product development plan. It is very typical for customers to be surprised by the length of this process which often delays 510(k) submissions.

Package Design (#1): 13 Weeks

Sealing and Manufacturing Process Dev. (#2/3) 16 Weeks

Transit Testing and Seal Testing (#4/5/6) 13 Weeks

Sterilization Validation (Assume Lot #1) 8 Weeks

These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.

Conclusion

The requirements for validating the back-end processes for medical device package designmanufacturingsterilization and shelf life of a sterile medical device is often misunderstood. Errors and oversights can result in failed validation tests and longer-term sterile barrier reliability. It can take nearly a year to get a validated sterile package to market, and many medical device manufacturers fail to plan for this time and expense. While there are regulations that govern package design and validation, additional regulations for manufacturingsterilization, and shelf life validation must also be coordinated to reduce lead-time, improve quality, and reduce costs. Using an integrated approach to treat all these processes as a system, achieves a faster and less expensive approach. OEMs should ensure that their medical device contract manufacturing partners are well versed in this area and can offer comprehensive schedules and cost estimates that reflect the entire process.

A cleanroom operator is carrying sterilized medical devices in a shipper carton

Medical device packaging and sterilization: a price you won’t want to pay twice

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Packaging and sterilization

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.

Can we connect?