Forming, Filling and Sealing, Oh My!

So, you’ve been assigned the job of purchasing and validating a new Form-Fill-Seal (FFS) machine? Congratulations! An FFS project can be a great assignment for packaging engineers who want to take their professional skills to the next level by working on high volume medical device packaging projects.

Form fill seal packaging projects challenge knowledge and test resourcefulness. They force you to apply sound analysis and decision making across a wide range of disciplines. They require business, operations, supply chain, packaging design, engineering and quality expertise. Lastly, be prepared to literally roll up your sleeves and dig into mechanics and maintenance. Oh, and did I mention that all of those must be synchronized and aligned to ensure the final solution is the right solution? Finally, here is the real kicker: there’s no going back once all that time and money is spent and you are staring at a large hunk of metal taking up half of your clean room. Trust me, this author’s been there.

This article is meant to give you a road map to success, based on personal experience with dozens of FFS packaging projects. I hope you’ll benefit from the best practices we’ve learned. First and foremost: don’t be intimidated!

Step 1. Assess your Manufacturing Environment

In other words, do you really need an FFS machine? Many people I’ve spoken to are intoxicated by the idea of cranking out thousands and thousands of finished products every month. Sounds pretty good, right? Well, have you considered:

• How are you going to feed thousands and thousands of products to the machine?
• Can your people or processes keep up with that?
• What about cartoning/boxing on the back end? Will parts pile up on the floor?
• What about lot sizes? Line clearances can easily take a half hour and burn several hundred feet of your top and bottom webs.
• How about the mix and variety of sizes and shapes? Changeovers are miserable, often taking an hour or two depending on the complexity of that changeover. Not to mention how expensive each toolset is.
• Do you have technically-capable people who feel comfortable performing service and maintenance on the machine? Are they available each and every shift? Full-on breakdowns aren’t as common with today’s FFS packaging machines – but considering how interlocked the sensors and alarms are, small glitches will shut down an entire line until they are identified and corrected. Do you have someone who knows maintenance of the form fill seal machine inside and out, so that they know what to look for?

Not to disparage FFS machines; they are a great technology for the right application. We’ve seen the best success when FFS machines are pursued a few years after product launch. Why? Because the operations and production teams have mature systems by now, there is a low likelihood of device design changes. Additionally, mix and variety is simple, volume is growing over time, and you can approach the project from a position of cost savings, without being under the gun gating a product launch.

Step 2 – Define Your Requirements and Expectations

Once you have established valid reasons to make the purchase, get into the details. It is critical to clearly state performance requirements as well as the expected impact it must make on your business to be considered successful. This is called a User Requirement Specification (URS). It should be provided to each FFS vendor with whom you engage for a bid. Considerations include:

• Volumes and throughput
• Printing and labeling
• How product will be fed to machine and then removed from machine on the backend
• How many people you want at the line (loading, inspecting, boxing)
• Physical space constraints
• Utilities available at your plant
• Cleanliness (in the clean room)
• Materials of construction for the sterile barrier
• Specifications for minimum formed film thickness, seal strength, and seal width
• Process controls and monitoring
• Calibration requirements
• Alarms and cycle-stops
• Safety and ergonomics
• Languages
• Expectations of service and support
• Potential future uses

Never expect that the FFS film supplier and other vendors “know all about” the requirements of ISO 11607 and ISO 13485. Also, never presume that any unstated or implied expectations will be met unless you clearly articulate them.

Step 3 – Don’t Skimp on Proof of Concept Methods

There is nothing more horrifying than failing a distribution test after the machine has been purchased and installed in your production environment. At that point, making changes to size, shape, and materials is not going to happen easily or cheaply.

Many FFS vendors have trial machines at their shop which they can use for proof of concept studies. To save cost and time, the toolsets are usually “Frankensteined” together or made with cheap, non-production packaging materials. They often lack small details or features, but something is better than nothing. Or so it seems.

FFS test items to consider:

• Running different types of materials or thicknesses
• Putting actual (real) products into the packages to make sure they fit
• Try different box quantities or configurations

Then, send the samples you made during this trial to a testing lab for feasibility drop and vibration testing. Does the sterile barrier remain intact? Are the parts protected? Are there any changes needed to materials, design, size, or shape?

Trust but verify!

Step 4 – Don’t Let the FSS Machine Leave the Factory Until …

This is 100% non-negotiable! You absolutely must personally travel to the manufacturing site to inspect the machine and put it through its paces.

Factory Acceptance Testing (FAT) can be accomplished reasonably within a 3 day visit. FAT activities and expectations should be written into a protocol that is signed by your team and by the vendor, so that everyone’s expectations are clear. Consider:

• Step through the URS and verify that all of your requirements have been met.
• Step through the original machine quote and verify that all features, bells, and whistles are included.
• Evaluate the machine similarly to an Installation Qualification (IQ)—consider safety features, verify that it operates as intended, check the utilities, check process controls, alarms, etc.
• Measure the tools to ensure that the intended dimensions, design, and features match the prints.
• Get trained inside & out by those at the factory who built your machine. Have them show you everything you could possibly want to know. Take videos and pictures. Write notes and instructions.
• Observe the machine operating at the intended production rate. Changeover to each and every toolset and watch the machine operate when each new toolset is installed.
• Physically mark (i.e. with permanent marker) the precise locations of any alignment mechanisms.
• Dial in time, temperature and pressure settings by running the machine through its operating range and testing samples for seal strength, film thickness, and package integrity. Save sealing, forming, and printing recipes in the HMI for later recall.
• Export and store backups of those recipes on a USB stick before leaving the factory.

It’s much easier to make final tweaks and adjustments at the factory before the machine ships. After all, they are motivated to get the machine out of their warehouse and collect your money. Make sure they earn it!

Step 5 – Final Installation and Debugging in Your Production Environment

Logistically, consider hiring third-party riggers to unload the machine and move it into position. Make sure your clean room will be cleared and not running other product – it will be busy and messy. Have utilities available and ready to hookup. Ensure that your IQ protocol is well written and that it offers a clear roadmap to follow as activities happen in real time.

At this point, you should be ready to undertake normal packaging validation activities (i.e. sealing and forming qualification, ship testing, aging). While we could spend more of your time discussing best practices for FFS validation, we’ll save that for another article at another time. Most importantly, we hope that at this point, you have developed the right packaging solution for your application and mitigated risk through due diligence at multiple steps along the way. Now is the fun part, so time to celebrate and reflect on what a cool learning process that was!

PCL’s engineers routinely work with FFS machines. We are ISO 17025 certified. We would love to chat with you about your next FFS project. Contact us today and let’s talk about how we can help with your success!