Ravona's strict validation process is designed to ensure that our global customers enjoy optimized aseptic operations.
Expert engineering is the key to isolator excellence, but it’s not enough. In order to ensure optimal aseptic operation, a thorough and continuous validation process is also required.
Ravona’s validation experts have designed a comprehensive process that is aligned with specific customer requirements, and ensures that their isolators have a 6-log reduction or more Sterility Assurance Level (SAL). The entire process is documented.
1. Pre-Cycle Development
2. Gassing Cycle Development
The objective of the gassing cycle development protocol (GCD) is to define and establish a robust sporicidal gassing cycle for routine use in normal aseptic operations, within specific aseptic isolators operated by Ravona’s customers. To execute the GCD, we use biological indicators that can effectively demonstrate the efficacy of the sporicidal gassing process (6-log reduction).
3. Performance Qualification
The PQ process has one central objective: to validate and approve the gassing cycles developed under the specific gassing cycle development protocol, for a single designated load pattern. The process is conducted several times, in order to ensure zero deviations.
Performance qualification revalidation takes place every six months-to-a-year, and is conducted onsite, at the customer’s facilities, in accordance with current load patterns.