Have you addressed these four common challenges to sterile packaging for your medical device?

Neil Thompson

Congratulations! You want to sterile package your medical device. Now what?

Here are four issues to keep in mind to make your packaging project a success.

Concern #1--Specifications and Design

Since budget is always a concern, the first question you should ask yourself is, "How many products or product lines do I want to package?" A package that fits multiple product lines or product sizes will drop your costs significantly by reducing the number of validations you need to perform. You can also consider a package scheme that fits two or three sizes and covers all product lines.

Concern #2--Sterilization Method

What's the most effective sterilization method? It depends. First, ensure that the sterilization method you choose is compatible with your product and your packaging materials. The two most common sterilization methods are gamma sterilization and ethylene oxide gas. If you choose gamma sterilization, check that your materials do not change color after sterilization since some materials such as Acrylonitrile-Butadiene-Styrene (ABS) and polyvinyl chloride (PVC) tend to turn yellow. With ethylene oxide gas, you need to make sure that there isn't residual gas left on your product. A good rule of thumb is if you need surface sterilization, choose gamma. If your product has intricate surfaces, go with ethylene oxide. Gamma can also penetrate through most materials, but it's dependent on the density of your product's component materials.

Concern #3--Lead Time

The choice between tray and pouch will determine the timeline. Trays have a longer lead time because their tooling is more involved and, in most cases, production trays must be completed before the tray sealer tool can be machined. Pouches do not require as much time because there is no custom equipment for sealing.

Aside from choosing materials and prototyping, the lead time includes three major validations that need to be completed: equipment implementation (installation qualification, operational qualification, and performance qualification (IQ, OQ, PQ)), packaging validation, and sterilization validation. The shelf life of your packaging validation will greatly impact your timeline. For example, if you want a two-year shelf life, accelerated aging can take 52 days. A five-year shelf life? That number can jump to 131 days (depending on the temperature profile chosen for the accelerated aging chamber). 

Concern #4--Manufacturing Implementation

If you currently manufacture in house and have a cleanroom set up, then implementation will include equipment implementation, standard operating procedures (SOP), and a slight restructure of your material requirements planning (MRP) system. The SOPs will typically be created as you finalize your IQ, OQ, and PQ reports.

If you don't have a manufacturing packaging facility, then you'll need to engage a packaging contract manufacturer that is ISO 13485 certified. It is important to ensure that this manufacturer has an ISO-classified cleanroom and has a proper MRP system in place that will be able to track all units per lots released. 

Neil Thompson is Business Development Director at Steriliant Sterile Packaging & Design. Reach him at [email protected].

[Image courtesy of TUMISU/PIXABAY]