Accessories

Validation capsules for Biological Indicators (BI’s)

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

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

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 fixed by the solid metal string

in ex. tubes, process tanks and especially safe placement through diaphragm valves.

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)

or Silicone (see certificate) approved by FDA.

See instruction “how to use” Sporfix® and how to fit the temperature sensor

and the solid metal string – video.

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.