When it comes time for sterilization, one of the first questions device manufacturers ask is what the packaging requirements are for chlorine dioxide (CD) versus ethylene oxide (EO).

 

The answer: You don’t need to package differently for CD or EO. Rather, your packaging considerations may determine if you choose CD or EO. The answer may surprise you.

The Changing Sterilization Landscape

Ethylene oxide (EO) has been a go-to standard for medical device sterilization for years, and for good reason. It sterilizes almost all medical devices effectively. It can penetrate packaging, plastic, and small spaces without damaging them, and sterilize otherwise hard-to-sterilize product configurations. In fact, according to the Food and Drug Administration, EO is used for about 50% of sterile medical devices – approximately 20 billion devices – every year.

 

However, EO also bears some key disadvantages requiring tremendous levels of caution and care. Along with often lengthy cycle times, it is a known carcinogen. EO is also a flammable, colorless gas that can explode if improperly vented, or handled. 

 

Enter CD. It can sterilize almost everything EO can – including plastic components and electrics – at room temperature. CD is an effective, efficient, clean, environmentally friendly method of sterilization. It is not a carcinogen. It is non-flammable and non-explosive at standard use configurations. It aerates quickly, reducing cycle times and eliminating the time-consuming post-sterilization aeration process. CD sterilizers also are easier and less expensive to manage than their EO counterparts. All told, CD can cost 10 times less than EO. 

EPA Final Rule on EO

Then, earlier this year, the U.S. Environmental Protection Agency (EPA) issued a final rule that will put in place the strongest measures to date for ethylene oxide commercial sterilization facilities – a rule that will impact virtually all medical device contract sterilization companies. 

 

The rule does not eliminate EO sterilization, but in working to reduce any exposure to it, imposes a number of requirements that make it more cumbersome and more expensive. Consider that a large sterilization facility could convert its EO chambers to CD for less than it would cost to comply with the new regulations.

Three Key Considerations

CD and EO are both here to stay. For some devices, EO will continue to be the sole sterilization choice. For many devices, how you package may open up options you did not know you had. 

 

• Utilization of chamber space

When you contract with a sterilization company, your cost will typically be based on the physical volume of the product you are sterilizing. Because device packaging must allow for sterile barriers, items are usually not packaged very densely. You’re also generally sterilizing devices in a pouch or try, which is put into a shelf box, which then goes into a cardboard shipping box. The entire amount of packaging – primary, secondary, and tertiary – creates excess volume. As a result, you are paying to sterilize a good amount of air. 

 

Medical device developers focused on speeding their products to market – and controlling costs – can work more smartly on how they utilize chamber space. For large batches of products or larger devices, CD may be more economical. The key, whether using EO or CD, is to incorporate thoughtful package design to fit more product into each sterilization chamber.

• Packaging material

How you package a device, and how much-corrugated cardboard you will have in a sterilization chamber, is a major consideration in sterilization. CD soaks into cardboard at orders of magnitude more than EO. If you work with corrugated cardboard packaging, EO may be the way to go. But think differently and you may find that CD presents a safer, more cost-effective option. For instance, perhaps you can change the shipping box to another material (such as corrugated plastic) or remove the product from the corrugated boxes and just sterilize it in shelf boxes.

• Trends in internal versus external sterilization

As CD gains in popularity, it’s likely that we will move from a focused system in which large contract sterilization companies perform most sterilization to a distributed system in which individual companies will install their own CD sterilizers and sterilize in-house. This will radically change the dynamic and economy of sterilization from both cost and logistics perspectives, as it removes a major element of shipping.  



Currently, manufacturers ship the device to a sterilizer and then pay for it to ship back or to drop ship it somewhere else. Costs mount up quickly. However, if handling sterilization in-house, shipping needs – and the associated costs and time – fall away. The packaging itself can change, too. Instead of a corrugated shipping box, for example, you may be able to sterilize in just a shelf box – or even do final packaging after a device has been sterilized. In that scenario, you can change the order of the process to fit more products in a given chamber, which decreases cost as well.  

Conclusion

Packaging has the potential to dramatically impact a device manufacturer’s bottom line and time to market. Whether the choice is EO or CD, considering the utilization of chamber space, the choice of packaging materials and industry trends will result in the most cost-effective, efficient process.

 

Article source: MPO