For many years Toxikon has been performing biocompatibility testing of medical devices.  Biocompatibility testing is a risk/benefit approach in understanding the safety of a medical device or product. That process can be pretty simple, using the guidance of ISO 10993 and regulatory guidance for industry. Resources like ISO 10993-1 and the FDA’s guidance available today can be helpful in risk assessment for a medical device but those documents are still a bit vague in some areas.

Medical packaging can affect the safety of medical devices for a number of reasons.  Contaminant transfer from the package to the device has happened and is always a possibility. A risk assessment of potential contaminants is helpful in understanding the packaging’s effect on the safety of a device.

When people ask me for guidance of what to do, here is what I generally propose.

Step 1:  Ask

Ask packaging and material suppliers for any available information related to the package.

Step 2:  Identify

Characterization per USP 661.2 – Plastic Packaging Systems for Pharmaceutical Use. This chapter of USP is specifically written for packaging systems for pharmaceutical and biologic products. This study will provide information on the physical and chemical properties of the system and contains published acceptance criteria that is useful in understanding the packaging system even for a device. The acceptance criteria of the assay are based upon results analyzed for the Absorbance, Acidity or Alkalinity and Total Organic Carbon of the system.

The only question at this time is “Does the packaging system contain PET or PETG?

This chapter of USP is specifically written for packaging systems for pharmaceutical and biologic  

Step 3: Understand

Biocompatibility:

• A Cytotoxicity test should be performed. I generally recommend a quantitative test with 4 dilutions. This in-vitro assay can provide a score used to predict the safety of the packaging system or materials used for the system.

• A Material Mediated Pyrogen test will provide in-vivo data and on the potential systemic effects of the packaging system and materials.

I generally suggest that the package should be evaluated after it has seen the complete process of manufacture and include package printing and labels.

The steps above can generally be completed within a few weeks for less than $4K. If an unexpected result is found in any of the above evaluations, you will now have a direction to explore the failure.  If not unanticipated, you now have useful data for risk evaluation of the package and a way to understand its effects on the product within.

Fighting the public health threat of counterfeit medicaments