Increasing Packaging Material Inventory Can Mitigate Supply Delays

Earlier this fall, the Advanced Medical Technology Association (AdvaMed) released a fact sheet on ethylene oxide (EtO) sterilization to refute fallacies about medtech manufacturers’ preferred disinfecting method.
 
“A false emerging narrative suggests ethylene oxide (EtO) sterilization is ‘cheaper, easier, and faster than alternatives and thus preferred,” states the fact sheet, released Nov. 1. “Modern Healthcare called it a ‘relatively cheap process that easily penetrates products, making it an attractive choice for device makers.’”
 
For many device makers, EtO is the only sanitizing option due to product size, shape, design complexity, or material composition. Some materials, in fact, actually degrade under radiation or steam decontamination processes.
 
Consequently, EtO sterilization has gained favor with the medtech industry over the last several decades despite its high costs. AdvaMed’s fact sheet notes that ethylene oxide is “often the most expensive, time consuming, and inefficient” sterilizing method. It’s also a more harmful method for human health, given its designation as a carcinogen by the U.S. Environmental Protection Agency.
 
Emissions from EtO sterilization facilities have prompted concerns and lawsuits from both (neighboring) residents and state and local governments. Eliminating ethylene oxide as a cleaning tool would have disastrous public health consequences, as more than half of all medical devices undergo this method of decontamination. “Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality,” AdvaMed has stated.
 
ODT’s packaging and sterilization feature delves into the controversy surrounding EtO disinfection as well as the trends and market forces driving the final stages of product development. Jennifer Gygi, B.S., expert technical consultant at Nelson Labs LLC, was among the experts interviewed for this feature; her full input is provided in the following Q&A:
 
Michael Barbella: What critical sterilization parameters impact packaging material selection and packaging design?
Jennifer Gygi: First, materials need to be compatible with the sterilization modality, meaning they will not severely degrade or lose strength after exposure to the sterilant. Next, the material needs sufficient breathability (for gas-based sterilization) to allow penetration of the sterilant and to equilibrate during sharp changes in pressure that occur within sterilization chambers. Many cycles include pulses where a substantial vacuum is drawn and then released, which can stress packaging seals if the material is not sufficiently breathable. Finally, the materials should be sufficiently durable to maintain the sterile barrier for the expected shelf life regardless of the sterilization modality used.
 
Barbella: How can supply chain-related packaging material shortages best be managed? What options are available to packaging/sterilization providers?  
Gygi: As the pandemic drags on and supply shortages increase, many companies are moving from a just-in-time approach to holding a larger inventory of critical supplies, like packaging. If you need to make a packaging change, either to a different vendor for the same supply or to a different packaging component, these changes need to be carefully considered. Any packaging change must be analyzed against the packaging validation, and while some changes can be more easily justified using a paper rationale, most changes will require additional validation testing to properly assess the impact of the change. As testing requires time and money, these should also be considered when looking for alternate packaging options.
 
Barbella: How can packaging material changes affect the packaging and/or sterilization process? What is required from a validation standpoint?
Gygi: Changes to the packaging (sterile barrier packaging or protective packaging) may make a device harder or easier to sterilize, which is why both the sterilization validation and packaging validation should be reviewed as part of a packaging change. The validation requirements will vary, depending on the estimated impact of the change and could be as simple as a paper justification or as complicated as repeating the entire validation. In most cases, some testing is required to show equivalence from the original to the proposed change or to confirm the estimated impact of the packaging change.
 
Barbella: How have packaging and sterilization providers learned to better manage supply chain risk in the wake of COVID-19?
Gygi: Given the challenges with packaging changes from a validation perspective, the best short-term approach may be to increase the inventory of packaging materials to buffer the impact of a delayed supplies. However, stockpiling materials can increase the severity of shortages for the industry as a whole. A long-term solution would be to validate additional options now to increase flexibility for the future. This applies to both packaging and sterilization. We have seen companies qualifying different sterilization sites as well as different sterilization modalities in some cases to allow for more options when a specific site gets backlogged (or closed). For packaging, having multiple sterile barrier or shipping configurations validated would provide more flexibility should a particular item become difficult to stock.