Sporfix

Validation capsules for Biological Indicators (BI’s)

Sporfix® has been developed by Ultrapharma in cooperation with our validation specialist.

The validation capsules Sporfix® for biological indicators are used during Qualification and Validation of:

Bioreactors and fermentors and other utilities
Equipment sterilized with SIP (Sterilization In Place)
Autoclaves

The biological spore strips that are used for this validation work have to be placed inside the pipework and be exposed to saturated steam. There is no standard solution for fixing the spore strip inside pipe work. Across the World everyone uses their own method of fixing the biological indicator (BI) of which some likely disappear during the sterilization process. Another aspect of these hand made solutions is that they introduce inconsistencies leading to failures or contamination of the BI.

Sporfix® and tool for safe handling, will add value to your validation by securing the biological indicators and temperature sensors during thermal studies.

The placement of Sporfix® is secured by the solid metal wire in ex. tubes, process tanks and especially safe placement through diaphragm valves. 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 Sporfix® and the outside connection can be any length. Sporfix® is designed for single use to avoid direct handling of the BI’s after studies.

The biological indicator in Sporfix® will after the thermal study, only be handled by the laboratory staff during incubation which will reduce the risk of cross contamination considerably.

The BI validation capsules are made of EPDM (see certificate), Peroxid Cured Silicone (see certificate) or Platinum Cured Silicon (see certificate). All materials approved by FDA.

For detailed and approved instruction of the BI validation capsule and tool – Instruction.

Request for quotation:

Request for quotation by clicking on the request form.

Contact and support:

If you have additional questions regarding Sporfix® or need technical support to your validation project, we will be glad to help you.

Send us an e-mail at info@qv-compliance.dk or call us at +4570707229.