While some medical device manufacturers (MDMs) have in-house packaging lines and capabilities, many companies use a contract packager for their medical devices. Small-batch sealers are relatively inexpensive, but large-volume production requires expensive packaging equipment that uses a lot of valuable floor space in a production facility. As a result, many companies opt to use a contract packager rather than make that large investment in equipment and space. If your company falls into this category, here are some important things to consider when using a contract packager.

Medtech Knowledge

Packaging is used everywhere for products ranging from food to consumer goods to medical devices and pharmaceuticals. The medical device and pharma industries operate under a unique set of rules and restrictions designed to ensure these products are safe and effective and, where required, sterile to the point of use. A contract packager that normally packages food items or consumer goods may not be aware of all the regulations and requirements for medical and pharma packaging. With the current COVID-19 crisis, many new players are entering the market trying to provide much needed medical supplies and personal protective equipment for the first time. Most of these companies are well meaning and are switching gears to help where needed, but they may not have the background or knowledge necessary to comply with the regulations.

Quality System in Place

The contract packager is a critical member in your supply chain. As such, you should follow your internal quality system to qualify them as a vendor. This would normally include routine audits of the services and facility (either via a paper audit or an in-person visit). Ensure the contract packager you select has the necessary expertise to follow all medical device packaging requirements. Verify through the audit that they are following all regulations. Do they have a quality system in place? Do they have a training program in place? Are their facility and equipment validations in place? Is there evidence that their processes are under control? Do they have calibration and maintenance schedules in place (and are they following them)? Do they have individuals who have the necessary education and experience to perform the required functions?

Package and Process Validations

While you will rely on the contract packager’s expertise and services, you will ultimately be responsible for the packaging of your medical device. This includes two key components: the packaging process validation and the packaging validation. When FDA audits your company, they will expect you to be able to produce all the necessary documentation that both your packaging and your packaging process has been properly and thoroughly validated. For the purposes of this article, we will be focusing on the packaging process validation. Let’s look at what this means.

Per ISO 11607-2, you must validate the packaging process. This includes at a minimum an Installation Qualification (IQ), an Operational Qualification (OQ), and a Performance Qualification (PQ) for the equipment used. You also need a process specification for the forming, assembly, and sealing of the packaging. The packaging equipment should be validated by whomever owns and uses the equipment. The contract packager should have an IQ/OQ on file for the sealer, documenting the initial installation. They should also perform a product-specific PQ with your device to show the package with your final product can be sealed to those process specifications previously set.

Where do the process specifications come from? The seal strength is dependent on the materials used in the packaging and the settings on the sealing equipment. The contract packager should be familiar with the materials in the packaging and the sealing equipment. They should know what the expected strength range could be. However, they would not know what your required minimum seal strength value needs to be. That will be dependent on what your device is and what minimum value is required to keep your package sealed with your product inside. If the contract packager has a generic, established minimum seal strength value, you are still responsible to justify to a regulatory body why this value is appropriate for your device. Ask the contract packager for copies of the IQ/OQ/PQ or a summary for your records so you have them readily available for an auditor.

In addition, the protective packaging is a critical component of the packaging system. Changing or improperly assembling the protective packaging can negatively affect the sterility of the finished device. The contract packager needs to have clear and concise instructions for assembling the packaging system. The assembly process should be verified.

Calibration Schedules

The contract packager is responsible for calibrating and maintaining the packaging equipment. For instance, they should have established procedures and policies in place to ensure the sealer is continually operating within the validated process parameters. This would include maintenance, calibration schedules and procedures, and routine quality tests of seals to ensure seal-strength values are in the range set by the validation. You should request supporting documentation for these activities for your files.

Training

The contract packager is responsible for the ongoing training of their employees. This would include operating the packaging equipment and inspecting the finished packages. Most companies perform some type of quality control inspection before boxing. This process should be documented and followed. Individuals performing inspections should have evidence of proper training and demonstrated proficiency in performing the inspections according to the written inspection procedure.

Change Control

Does the contract packager have change control procedures in place? Changes in equipment, processes, or supplies need to be evaluated for potential impact to the packaging system. Some changes will require that additional validation activities be performed. Are you notified of changes and are the changes evaluated for impact by the contract packager? You will need documentation of changes made and their impact, either provided by the contract packager or written by your company.

Appropriate Design Support

Lastly, let’s touch upon design. Ensure any package recommended by the contract packager meets the specific needs of your device. Packaging needs to be of an appropriate size for the product, sufficiently durable, protective to withstand the rigors of transportation and distribution, and be designed for sterilization compatibility. Even though the contract packager is recommending a package, you are responsible for justifying the selection of the packaging (why the size is appropriate, why the materials were chosen, why the protective packaging was selected, etc.).

Moving Forward with a Contract Packager

The contract packager is a valuable partner. Many companies rely on their expertise and services to package medical devices and pharmaceuticals, but the ultimate responsibility for what they do resides with the medical device manufacturer. The same level of care and concern that is spent on device production needs to carry over into the packaging process. Carefully perform your due diligence with your contract packager to ensure this critical step in your device production meets all your quality expectations.