Sterilization Development

Lifecore has decades of experience, using its proprietary filtration system, filter sterilizing very high viscosity solutions (>100,000 cps sodium hyaluronate solutions) while conforming to industry standards for filter sterilization.

Our engineers and filtration specialists can help you with your most challenging product filtration problems. After development, our validation engineers ensure that you have a robust, validated filtration system.

Two separate considerations are made during drug product sterilization development:

  • Primary sterilization is usually accomplished by sterile filtration, but sometimes, by heat or radiation. Additional routes to primary sterilization can be explored in formulation development.
  • Drug products that will be used in a sterile surgical field are secondary sterilized. The outer surfaces of the syringe and inner surface of the packaging are treated with ethylene oxide (EO).
  • Lifecore’s process development and validation specialists work with qualified contractors to design secondary sterilization parameters meeting the industry standard requirements for ethylene oxide sterilization.

Additionally, we have experience with terminal sterilization meeting the industry standards for gamma irradiation, e-beam and steam. We work with outside vendors to validate an appropriate cycle.