The medical device industry is increasingly relying upon the use of bioabsorbable implants, and that trend will continue to grow. In fact, the bioabsorbable stent market alone is expected to reach $2.4B by 2021, up from $400M in 2016, according to a 2016 MarketsandMarkets report. Traditional sterilization methods, however, have typically posed significant problems for implants like bioabsorbable stents and related FDA Class II and Class III medical devices.
vaporized peracetic acid
Inventor of VPA technology and current Director of Research & Development and Operations with REVOX Sterilization Solutions, Mason Schwartz, discusses the science behind VPA.
1. The VPA sterilization process has a distinct advantage over many other sterilization solutions because it is executed at room temperature. From a chemistry standpoint, why is this important?
- Sterilize products without exposing them to high temperatures, moisture, radiation or hazardous chemical by-products
- Gently sterilize all surfaces of a product within its package, leaving behind no residuals
- VPA breaks down into relatively harmless, natural occurring substances: water, oxygen and carbon dioxide
- Safe and easy to install, the VPA system adds efficient in-line sterilization to your manufacturing process
Because REVOX room-temperature sterilization is a recent innovation in industrial disinfection, medical manufacturers are often curious about how vaporized peracetic acid (VPA) could be used in the process without damaging their products. REVOX co-inventor Mason Schwartz says he occasionally encounters some initial misunderstandings about the chemical reaction, and he notes that it’s crucial to differentiate liquid PA from vaporized PA, which is used in the REVOX process.
On-site placement and operation of the REVOX vaporized peracetic acid (VPA) sterilization units are safe, simple, and efficient.
Available large-capacity units can eliminate inefficiencies associated with off-site processing, such as long turnaround times, external quality processes, and the need to maintain large inventories. In-production-line - or JUST-IN-TIME STERILIZATION™ - may further optimize your efficiencies.