Rubber Fab is proud lo introduce a new product that enables the use of a self contained biological Indicator In sanitary process lines. This unique Rubber Fab Smart Gasket® permits either Lop loading or Inline positioning of an IZTest® self contained biological indicator and/or a temperature probe.
The great advantage of a self contained biological Indicator over the traditional spore strip in glassine is the time saved when confirming spore kill. Results are easily obtained in only 48 hours (versus the five to seven days required with a spore strip) and without problematic laboratory transfer.
You can feel secure knowing that the biological Indicator will mil be lost down stream in the process. The tail-safe Rubber Fab Smart Gasket® holds the indicator in place for easy retrieval. Available for 3/4”, 1.0”, 1.5” and 2.0” Sanitary, Tri-Clamp process lines. The Biological Indicator Gasket is also available with one (1) Smart Gasket Thermocouple Port.
Meets High Pharmaceutical Standards
- U.S. Pharmacopeia Glass VI Certification
- Cytotoxicity Criteria
- CFR Title 21 Section 177.2600
- Traceability: Lot and Batch
- Certification: Lot and Batch
- ASME-BPE Standards
- USDA Standards
- 3-A Sanitary Standards
- Currenl Good Manufacturing Practices (CGMP)
Validation of steam systems
- U.S. Pharmacopeia
- ISO 11138
- European Norm 866
- Pharmaceutical Tanks
- Sanitary Inline Pipes
- Pharmaceutical Hose