Jeff Sauter, Business Development Manager at Nutek, talked about sterilization efforts for healthcare products and medical devices, atwww.bio2devicegroup.org event.
Most commonly used forms of sterilization are EtO, Gamma and E-Beam with X-ray sterilization as an emerging ‘new’ technology. Nutek is an E-Beam sterilization facility that is FDA and DEA registered and is ISO 13485 and ISO 11137 certified and is going through ISO 11135 certification for EtO, said Sauter. While Nutek is known in the industry as a niche player and is sought out world-wide to solve complex sterilization issues, they also have the capability to sterilize large volumes of product.
Sauter discussed various sterilization modalities. SmartEO Ethylene Oxide Sterilization or EtO is effective and cheap modality for R&D testing as a well as for high volume and low volume production. It is used for terminal sterilization of devices. With EtO, it is important that the packaging is breathable where it may be torturous route for microbes to get in but gas can still get in for sterilization. Primary challenges are with residuals and significant environmental concerns have led to EU mandates to exhaust all other sterilization methods before resorting to EtO.
Gamma radiation method is effective and cheap and can also do high volume. However, there are significant security issues surrounding gamma. In December 2013, in Mexico,hijackers opened the canisters being transported in a truck and disappeared unaccounted for, said Sauter. If it falls into the hands of the terrorists, they could potentially make a dirty bomb. Gamma also needs to be disposed of properly and it is buried permanently deep in the earth.
E-Beam has some advantages over Gamma. E-Beam is less harsh to the product as compared to Gamma, said Sauter. In case of Gamma, the product resides in the Gamma chamber and is exposed to radioactive energy for several hours. Whereas E-Beam, typically a high energy electron beam goes over the product in less than a minute. E-Beam also offers more flexibility in processing of sensitive drugs or biologics. E-Beam offers advantage of continuous temperature control, split dose processing, and intelligent tooling. It also offers more scalability for processing differing volumes and turnaround times can be much faster, compared to Gamma. E-Beam is also environmentally friendly and poses no security risk.
The technology in X-ray has only recently caught up to make it a practical modality, in sterilization, said Sauter. X-ray is also emerging as a more obvious choice over Gamma. X-ray delivers doses rapidly, allows for greater temperature control, allows for maintaining tight dose range, can penetrate all types of product packaging including foils, and causes no damage to sterile seals on product packaging. Nutek is moving a new facility in Fremont, which will include state of the art X-ray sterilization modality.
All modalities have their place, their advantages and limitations, said Sauter. If any product contains Teflon or electronic components then EtO is the more likely methodology to go with. It is very important to consider sterilization modality earlier in product development. Sometimes a wrong modality is chosen and the result is good, viable products don’t see the light of the day, said Sauter. Some of the important considerations in choice of a sterilization modality are: material compatibility and product functionality, product and packaging qualification, bioburden issues and dose selection, modified atmosphere packaging considerations, security and environmental risks, future sustainability, and cost considerations.
The session was followed by Q&A.