The Sporfix® is a new concept used during the qualification and validation of Bioreactors and Fermentors and other utilities. It can especially be used to control SIP validation in harsh environments.
The placement of the Sporfix® is secured by the solid metal wire. This wire and the thermocouple wire are taped together and brought inside the system through either a valve membrane or a sampling gasket. The distance between the Sporfix® and the outside connection can be any length. The Sporfix® is designed for single use to avoid direct handling of the BI’s after studies.
When the sterilization cycle has ended the Sporfix® will be removed from the wire by cutting the wire. The biological indicator in the Sporfix® will after the thermal study, only be handled by the laboratory staff during incubation which will reduce the risk of cross-contamination considerably.
Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries.
Successful SIP validation depends on more than accurate temperature measurements alone. The positioning and handling of biological indicators are equally important, yet traditional methods often rely on improvised solutions that can lead to inconsistent placement, lost indicators and an increased risk of contamination. Sporfix® was developed to standardize this critical step in the validation process.
By providing a secure and repeatable method for positioning biological indicators, Sporfix® helps improve the consistency and reliability of validation studies while reducing manual handling after sterilization. The single-use concept minimizes the risk of cross-contamination and supports a more controlled qualification process for bioreactors, fermentors and other SIP applications.
Developed in collaboration with validation specialists and extensively tested in real-world pharmaceutical environments, Sporfix® reflects Ultrapharma’s commitment to simplifying validation while improving process integrity and operational confidence.
Standardize your validation. Increase confidence in every SIP cycle.
Available Compounds
Available Compounds
For even smaller ½” tubing area’s we have developed an extra small (short) Sporfix®. This one is only 46 mm long and can hold a blue envelope Sporestrip which is only 25 mm long. This will open up lots of new opportunities to constantly measure SIP validation sterility tasks.
Available Compounds
Our technical team is ready to help you select the right solution for your application
