Product/Service

Biologic and Pharmaceutical Sterilization

Source: REVOX Sterilization Solutions

Peracetic Acid (PAA) vapor is a gentle, room temperature sterilization method available for fragile biologicals. Since large molecule biologics have a complex molecular structure, the Revox sterilization process is ideal for ensuring sterilization while leaving delicate proteins intact and not harming the efficacy of the biologic. 

Paracetic Acid (PAA) vapor sterilization has an advantage over ethylene oxide (EtO) processes in that it does not degrade the pharmaceutical or biological compounds within syringes or other drug delivery mechanisms. During EtO processing, aeration cycles can unplug syringes creating an ingress opportunity for EtO to reach the syringe content.  Unlike the elevated temperatures associated with EtO sterilization processes, the Revox sterilization process operates at room temperature, allowing sterilant contact with the syringe’s contents without compromising the functionality of the syringe.

Typical Sterilization Challenges

  • Materials compatibility issues associated with “low” temperature gas sterilization, radiation, and steam methods
  • Chemical residuals impacting device integrity, quality or safety
  • Long contract processing turn-around times associated with pre-conditioning and post sterilization aeration requirements
  • Small in-house gas plasma chamber options limit throughput efficiencies
  • Exorbitant capital requirements to achieve on-site efficiency
  • Limited dedicated, expert support to address unique project objective

Peracetic Acid (PAA) Sterilization Solutions

  • Gentle room temperature process (18oC – 30oC)
  • No harmful residuals
  • PAA chemistry breaks down to CO2, H20, and O2
  • No lengthy pre-conditioning or post-processing aeration required
  • Multiple chamber configuration options for safe, efficient, on-site sterile processing
  • Fast turn-around contract sterilization services
  • Expert guidance to help meet technical, operational, and financial project objectives

Download the brochure for more information on Revox’s biologic and pharmaceutical sterilization.

To learn more about how you can bring sterilization capabilities into your manufacturing facility please click here.