Cycle Development & Optimisation
The key objective of Cycle Development is to ensure that the product or load item is sterile and functional at the end of the cycle. This often requires careful control of the cycle parameters to ensure these objectives are met in conjunction with the development of a qualification approach to demonstrate the desired Sterility Assurance Level (SAL) objectives are achieved during Performance Qualification.
Experience really helps to determine the most effective cycle parameters and tests to demonstrate the steriliser cycle is effective in the shortest time.
Some examples of cycle development carried out by the Honeyman Group;
- Pre-filled syringes
- Aerosol products / filled canisters
- Components used in Biotech processes
- Complex filling manifolds
- Implantable medical devices
- Heat sensitive medicinal products
To schedule a free initial (confidential) consultation call with one of our subject matter experts, please contact us with your details and a short introduction, so we can arrange a call back at a time convenient to you.