The Biological Indicator Gasket
Rubber Fab is proud to introduce a new technology that enables the use of a self contained biological indicator in sanitary process lines. This unique Rubber Fab Smart Gasket® permits either top loading or inline positioning of the EZTest® self contained biological indicator and/or temperature probe.
Patent #6,927,058
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The Biological Indicator
Gasket
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 24 hours (versus the 5 to 7 days required with a spore strip).
You can feel secure knowing that the biological indicator will not be lost down stream in the process. The fail-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.
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Meets High Pharmaceutical
Standards
• U.S. Pharmacopeia Class 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
• Current Good Manufacturing
Practices (CGMP)
EZTest®
• U.S. Pharmacopeia
• ISO 11138
• European Norm 866
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