Custom equipment is used for automated packaging at a medical device contract manufacturing facility

Breaking down barriers to scale up medical device manufacturing

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medical-device packaging equipment

Medical device companies are under intense pressure to develop programs that get their products on the market fast.

For the leaders in charge of the small or mid-sized firms that don’t have in-depth manufacturing engineering or manufacturing expertise in-house, that pressure manifests in the questions they repeat as they lay awake at night.

Does my contract manufacturer know enough to help me through the process? Can they scale up on my timeline? How can I know I won’t get burned when it’s time to ramp up?

The answers to those questions depends on who you have in your corner and the depth of guidance they can provide as you take your program out of the lab and onto the market.

As you read, you’ll see that the art of scaling up is about knowing what to plan ahead for.

How to think about process validation

A critical area of advance planning necessary for successful scale-up is settling on a consistent way to verify the repeatability and reliability of medical device manufacturing and packaging.

What do we mean by consistent?

When programs are in development, it’s common for prototypes or trial runs to be inspected after assembly and packaging. Human inspectors can easily manage a pace of a few hundred units a day.

Obviously, the situation changes at high volume. For one thing, when you’ve ramped up to tens of thousands of units daily, human inspection is infeasible. For another, medical device and packaging inspection is often destructive.

So, contract manufacturers instead rely on well-controlled processes to stand in when final inspection either is unrealistic or destructive. In other words, they master the art of working backwards. It requires:

  • A deep technical understanding of which process parameters and equipment settings cause variability you would ordinarily inspect for
  • Implementing controls that eliminate that variability
  • Demonstrating via testing that those controls are adequate and can be maintained

Consider the nuance within that final point above and you’ll see why the validation process can be such a headache. The process you validate must be effective now and later. It has to work as well today as it does under the rigors of manufacturing at high volume.

Case in point: J-Pac is currently working with a customer that developed a nasal swab test for detecting COVID-19 among other respiratory conditions. While the customer supported some packaging and sterilization capabilities in-house, they lacked the specific equipment required to package and sterilize this novel product in a way that could be validated. On top of developing a valid packaging and sterilization process, J-Pac committed to investing in additional equipment and owns raw material sourcing to continue packaging and sterilizing the customer’s products through ramp-up to full production.

Supply chain management and bottleneck planning are essential

Of vital importance to any program is marshalling resources and organizing the complex network of suppliers needed to successfully scale up medical device manufacturing.

Some companies try to manage this aspect of their programs on their own to save time and money. Unless they have a seasoned logistics pro on staff, this often comes back to bite them.

If you’ve had the rug pulled out from under you because your supply chain wasn’t as robust as you thought it was, you know the feeling.

It’s better to lean on your outsourcing partner for supply chain management because they’re trained to ask: Where will this process break down? What are the bottlenecks? How can we prevent them before they even emerge? Consider what such a partnership can achieve for you:

First, the right outsourcing partner has connections to a much wider supplier network than you. When they leverage it, it gives you a head start in sourcing materials that match your exact product specifications.

Second, they’re keenly aware of how your supply chain needs will change as your program ramps up. They vet suppliers with one eye on the present and the other on the future. You need suppliers who can keep you stocked today and tomorrow. The ideal outsourcing partner usually knows which suppliers are better able to adjust their capacity according to changes in demand (and can get them to commit to that flexibility under the terms of supplier contracts).

Third, if you engage them early enough, your outsourcing partner’s advance supply chain planning might even drive changes to your design or manufacturing process that generate cost and time savings.

In our view, supply chain management is not an expense anyone should try to avoid. It’s one of the most important risk management plays you can make.

Good process design flattens ramp-up costs

By the time a medical device is approved for commercial production, your manufacturing process is set in stone and must remain intact even as production volumes ramp from hundreds or thousands to millions.

But developing a process that can sustain exponential increases in volume over time is only part of the story. Even a process that “works” is no good if the cost to run it rises on the same curve as volume. We’ve seen many companies wrestle with a bad process that forced them to plow would-be profits back into frequent capital expenditures.

The alternative — halting a program to re-validate a better process — is even worse.

The ideal outsourcing partner should understand your product and program well enough to develop processes that make the most efficient use of capital equipment expenses. This does not mean we want to skimp on equipment. Rather, it means that we bring equipment online within a process designed to harness its most efficient future use.

That means we need to break apart the steps in a manufacturing process and then add discrete equipment to those steps. It might appear counterintuitive or clunky early on, but it’s designed so that a linear addition of manpower to existing infrastructure drives an exponential increase in volume. In our experience, this is the most effective way to scale a program that breaks through to profitability quickly. 

Walking that example backward in time, you can see from another angle the importance of planning ahead during the validation stage. Your success hinges not merely on having a validated process, but on validating the right process.

Case in point: We’re currently helping a new-entrant customer commercialize a device designed to simplify laparoscopic surgery. Our work so far has focused on developing a packaging and sterilization process which is currently under review by the FDA and European regulators. As a young company, the customer approached suppliers in search of one who would take them seriously and guide them through a complex process. In digging into the process and making helpful suggestions during process design development, J-Pac shortened the customer’s project timeline by three to four months.

Chart a course for your competitive edge

Medical device company leaders pour countless hours into developing products that advance the healing art. They need guidance from technical experts to execute the science of getting those products to market.

J-Pac Medical is committed to breaking down the barriers and providing the close support you need to secure profitability and maintain the competitive edge.

If your program is approaching a critical stage, now’s the time to contact us.

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?

A compliance flowchart explaining how to understand ISO FDA Requirements

Understanding ISO 13485, ISO 11607 and FDA 510(k) to get to market faster

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Understanding ISO and FDA requirements graphic

A truckload of statutes, standards and benchmarks govern the way medical devices are designed, manufactured, packaged and marketed. Medical device companies bringing new products to market will be familiar with these three which are specifically important:

ISO 13485 – The most widely accepted quality management system criteria that companies, including contract manufacturers, must meet if they serve the medical device industry.

ISO 11607 – It specifies the requirements and testing methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems; this information is essential to earning FDA clearance to market a product.

FDA 510(k) – Documentation submitted to the U.S. Food and Drug Administration that demonstrates a new product is similar enough to a prior-approved predicate that the lengthy Premarket Approval process is unnecessary.

Below, we illustrate how processes are streamlined and time to market is compressed when a turnkey manufacturing outsourcing partner is engaged in the hard work of meeting these requirements.

The FDA 510(k) submission matters most, so we’ll start there.

Don’t let FDA 510(k) be a bottleneck

Gaining FDA clearance to market a new medical device via the 510(k) submission process is much-preferred compared to the Premarket Approval process.

If you’re under pressure to get to market fast, and the product you’ve developed is substantially similar to a product already cleared by the FDA, you could earn 510(k) clearance in as little as 90 days.

On the flip side, it could take much longer if

Documents compiled in the 510(k) submission demonstrate that your company follows the Good Manufacturing Practices (GMP) as defined in federal law (21 CFR part 820). Aspects of GMPs include:

  • Adequate design and manufacturing controls
  • Supplier management procedures
  • A way to receive and investigate complaints

To earn clearance as quickly as possible, it’s imperative that you collect and organize all the information the FDA needs to see to make a speedy ruling. Among the documents the FDA requires are data showing the package design will work for the shelf life required, the process to manufacture the packaging is reliable and the sterilization process is validated.

In our experience, small or midsize device companies are sometimes taken by surprise here. Often, they initiate the submission process before solidifying a packaging and sterilization plan. The potential bottleneck that emerges here can set timelines back by several weeks — an amount of time no company can afford to lose.

Engaging an outsourcing partner earlier in program development will give you greater awareness of what the 510(k) process requires. Choosing a turnkey provider can accelerate the process because they coordinate the myriad tests the results of which are required as part of the submission.

Learn about J-Pac Medical’s turnkey approach here.

(Note: While the GMP requirements under FDA 510(k) mention the ISO 13485 standard — and even though the FDA in 2018 stated its intent to use 13485 as the basis for amended quality systems legislation — the two today remain separate and their distinction is important to understand.) 

Developing processes that meet ISO 13485

ISO 13485 covers much of the same ground as the FDA does in its GMP rules. And while the former standard is voluntary in the U.S., it might as well be a prerequisite here for all the importance that device companies place on their suppliers and contract manufacturers in being certified.

If you intend to market products for export to Europe in addition to domestic sales, ISO 13485 is legally required by the European Union.

The certification goes a bit further in its requirements than the FDA, assessing the structures and systems that impact how a company is managed. For one example, to earn the certification companies must show that they have strong resource allocation abilities. For another, certified companies must prove they have mechanisms in place to receive and investigate complaints and identify corrective actions.

Also, ISO 13485’s requirements pertaining to the validation of manufacturing and packaging processes for which verification is destructive or too expensive are stricter than what FDA mandates.

(As an aside, note how interconnected all these requirements are: Validation is also a hallmark aspect of the ISO 11607 standard described below; the results of testing conducted in the pursuit of meeting ISO 11607 requirements are instrumental to earning clearance from the FDA.)

Importantly, ISO 13485 tells us what is required but gives no guidance on how to achieve it. Same goes for the FDA. That being the case, the how falls on device companies and their outsourcing partners.

In the case of small- to medium-size device companies that require added guidance from outsourcing partners to launch new products, it’s imperative that their partners can develop quality procedures that comply with both FDA and ISO requirements at once.

Navigating the complexities of ISO 11607

If the FDA 510(k) submission is the most important documentation generated in your medical device development program, then the ISO 11607 standard is the most complex.

Consider that the 11607 standard is over 50 pages long and references an additional 100 standards within its text. It’s hard enough to grasp that the Association for the Advancement of Medical Instrumentation (AAMI) saw fit to publish a technical report providing guidance on interpreting the standard. That guidance is twice as long as the standard itself.

Boiled down, companies developing processes in compliance with the standard must show:

  • How a product is designed
  • That the way the product is manufactured and packaged will work
  • Test results proving the products will survive transport
  • Test results proving the product meets stated shelf-life requirements

In our experience, medical device companies underestimate the complexity of meeting ISO 11607 requirements.

In fact, around 30% of all device packages fail their validation test.

Obviously, companies under pressure to launch products on aggressive timelines shouldn’t accept only a 70% chance of success. A turnkey manufacturing outsourcing partner with the right knowledge and capabilities in place will know what it takes to pass inspection every time.

A summary of J-Pac Medical’s suite of packaging development and testing capabilities illustrates the point:

  • Established knowledge and existing networks of available raw material sources
  • Biocompatibility testing to guarantee a good match between selected packaging materials and manufacturing equipment and processes for sterilized products
  • In-house tooling, thermoforming and photorealistic rendering to aid in prototyping
  • In-house verification testing to predict future formal test results or anticipate potential failures and develop corrective action

All told, bringing all this under one roof can shave as much as two months off your launch timeline.

Another key benefit that relates specifically to meeting ISO 11607 criteria is that your product might be a candidate for pre-validated packaging.

Once your product design is solidified, good manufacturing outsourcing partners should determine whether the product can be packaged using materials and processes that have already faced scrutiny under ISO 11607 criteria.

In our view, there’s no need to reinvent the wheel. If we don’t have to, we won’t, and the timeline to launch your product can be further reduced by several weeks.

Reduce risk and commercialize faster with turnkey outsourcing solutions

Medical device companies know they need to meet the many requirements that govern the development of the innovative products they create. But actually bringing these innovations into the world can be daunting.

It is J-Pac Medical’s mission to own the process with turnkey assembly, packaging and sterilization solutions that meet regulatory muster so you can deliver these essential products to clinicians and patients without delay.

If you’re staring at the regulations and standards and wondering how you’ll get it all done on a tight timeline, we might be the partner you’re looking for. Contact J-Pac now.

Factors influencing reagent blister manufacturing costs

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“Cost” is an awfully big word for being only four letters.

And as developers of point-of-care diagnostic reagent blisters know well, the costs to bring reagent blister products to market have many different sources.

Some are easier to spot than others. Some stay hidden until it’s too late, putting years of work (and lots of money) in jeopardy.

Here, we offer our take on manufacturing cost drivers and share ways a manufacturing partnership can keep your program on track for successful commercialization.

Reagent blisters of various shapes and sizes

Reagent type

The characteristics of the reagent held within a blister will impact material and manufacturing decisions that influence overall cost in two main ways.

First, some reagents are corrosive to the plastic lining of material layers that are welded together to form blisters. The corrosive effect can degrade the seal over time, increasing the risk of a leak that could damage costly analyzing equipment. To combat this, materials with different barrier properties or a different heat sealing process might need to be specified.

Second, some reagents are temperature-sensitive and must be kept refrigerated. That introduces the following cost drivers:

  • It’s much more costly to ship bulk reagent in refrigerated containers
  • It’s more costly to keep reagent in refrigerated storage
  • The heat sealing process of blister manufacturing becomes much more complicated for reagents that degrade when exposed to heat

The earlier a product developer is aware of these potential issues, the more proactive they (and their manufacturing partner) can be in identifying material or manufacturing process alternatives that keep programs on track for timely, cost-effective commercialization.

Blister material set

As the applications of point-of-care testing have evolved, so have the materials available to manufacture reagent blisters.

As this variety widens, it’s critical that developers understand that cheaper is usually never better. Granted, some programs in which the cheapest materials are specified can be successful. But in our experience, that’s rare and often only coincidental.

It’s better to rely on thorough investigation and sound engineering to land on the right materials that will result in the most reliable, least risky large-scale manufacturing.

Reagent blister processing tray

Validation requirements

Depending on industry or statutory requirements, some blister products must undergo more intensive testing for validation prior to commercialization.

Manufacturing partners add value to this stage of product development because they understand how to appropriately manage product development and manufacturing timelines that account for more time-intensive validation stages.

They also understand the additional raw material requirements that must be satisfied for successful product testing (for example, the difference in cost between non-destructive and destructive testing that results in reagent loss can be significant).

Finally, they know how to develop validation processes and are familiar with the equipment required to execute them.

Seal strength and pierce force specifications

Seal strength refers to the strength of the bond formed when blister materials are welded together via heat sealing. Pierce force is the force required to cause the blister to break to access the reagent for testing.

It’s critical that a blister’s seal strength be greater than its pierce force. If a seal is weaker than the force required to puncture a blister, reagent will leak out of the blister from the failure site and potentially damage the sensitive electronics inside an analyzer.

However, material capabilities and reagent chemical properties make for a tricky tradeoff.

For one example, some materials are incapable of achieving extremely high seal strengths regardless of how the manufacturing process is tweaked. For another, even if chosen materials and an adjusted manufacturing process do achieve a given seal strength and pierce force combination, it’s all for nothing if the reagent cannot tolerate those parameters.

Developers and manufacturing partners must learn in advance whether it’s more cost effective to iterate on material specs or manufacturing processes to accommodate actuating equipment characteristics, or whether revising the actuation process will allow for the use of more established and cost-effective materials.

Manufacturing expertise from J-Pac

Any successful reagent blister product development program hinges on the combination of the right materials and the right manufacturing process to produce blisters by the million without fail.

As such, J-Pac Medical’s diagnostic reagent blister service emphasizes design for manufacturability. This solution-seeking approach guides customers toward simplified product designs that reduce complexity and variability in manufacturing. It results in a more robust and reliable production program that saves time and money.

What reagent blister product development challenges do you face? Our engineers are ready to lend their eyes and ears to help identify the right solution. Talk to one here.

The challenge of pinpointing reagent blister seal strength specifications

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The mechanical forces specified to access reagents packaged in on-board microfluidic blisters used in point-of-care diagnostic products is essential to their clinical use. But designers of these products must consider how these activation forces relate to risks inherent to the blister manufacturing process that could manifest in later clinical use.

Identifying the ideal blister pack seal strength is arguably the most important consideration. Some practical challenges must be addressed to ensure a blister development and manufacturing program is viable for mass production.

Point of care diagnostic consumable cartridge  with blisters

What is reagent blister seal strength?

A reagent blister is manufactured from polymer-lined foils that are cold-formed into shape and then heat-welded to create a perimeter seal around the blister that keeps the liquid from leaking out.

Typically, a reagent blister is activated by a mechanism within the diagnostic instrument that applies pressure to the top of the blister while a piercing mechanism punctures the bottom of the blister, enabling the reagent to flow from the blister to the microfluidic consumable. The force required to pierce and extract the reagent from the blister is termed the “activation force.”

Seal strength differs from activation force in that it is the maximum force that the blister can withstand without leaking. Seal strength refers to the strength of the bond made by heat welding the perimeter of the blister foils, which contain plastic laminate layers that bond to each other under heat and pressure. Material characteristics, blister geometry and heat seal process temperature combine to determine the strength of that bond.

In addition, the chemistry of the reagents may cause the seal to weaken over time, so it is crucial that product developers and manufacturers choose materials wisely.

Seal strength is a critical risk management metric

In general, microfluidic-based diagnostic test developers favor higher seal strengths to prevent blisters from leaking. Higher seal forces prevent blisters from leaking their reagents onto delicate test instruments, which can risk severely damaging the sensitive electronic equipment contained inside. It’s a costly problem that also invalidates the diagnostic tests the equipment is designed to perform.

However, there are costs and technical limitations to the seal strengths that can be achieved. Reliability, or process capability, is essential. Developers should partner with manufacturers during program development to conduct compressive force testing to identify the ideal design and manufacturing specs that will result in the most reliable high-volume manufacturing of these critical products.

Dome shaped pierceable diagnostic blisters

Manufacturers must manage tradeoffs

There is a tradeoff relationship between the blister activation force and the burst force that causes the perimeter seal to fail. If the force required to activate the blister is greater than the blister’s perimeter seal strength, the blister will leak. Likewise, even if the activation force is less than the seal strength, a malfunction of the piercing mechanism can cause a buildup of forces within the blister that also exceeds its seal strength. This will also cause a leak.

One of the ways product designers have historically addressed the risk of blister leaks has been to specify very high seal strengths. Likewise, designers tend to specify strong activation mechanisms to minimize the chance the blister fails to activate.

But sometimes these specifications do not account for limitations imposed by the blister materials, manufacturing process parameters and reagent chemical properties that react with the seal. There will be a unique limit to the maximum seal force that can be achieved depending on how those variables interact.

For one example, the upper limit of seal strength differs depending on foil and polymer coatings materials. Some materials might not be able to achieve a specified seal strength regardless of how manufacturing parameters are tweaked.

For another, temperature-sensitive reagents cannot tolerate prolonged exposure to high-temperature tooling responsible for welding blister material layers together.

How a device manufacturer can help

Partnership with a medical device manufacturer closes the circle for product developers by delivering a comprehensive understanding of manufacturing considerations to product development challenges.

J-Pac Medical was among the industry’s first to provide reliable manufacturing of reagent blister products. Our engineers’ expertise has been essential to identifying the fastest, most reliable and most cost-effective pathways to market for some of the most commercially successful diagnostic reagent blister products.

It’s helpful to show as well as tell, so we invite you to order a sample blister kit as you consider working with a manufacturing provider. And if you want to make our team part of your own, let’s get in touch.