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Smart Gasket® For Biological Indicator Validation In Sanitary Process Lines.pdf

biological-indicator-gasket.pdf
Preview of Smart Gasket® for Biological Indicator Validation in Sanitary Process Lines
🔗 Source: auspol.com.pl
📊 Size: 989 KB
📄 Pages: 2 pages
⬇️ Downloads: 202

Summary

Rubber Fab introduces the Biological Indicator Gasket, a product designed for sanitary process lines that integrates a self-contained biological indicator and/or temperature probe. The Rubber Fab Smart Gasket® supports both top loading and inline positioning of EZTest® indicators, offering rapid results in 24 hours compared to traditional spore strips which take five to seven days. This gasket ensures secure placement and easy retrieval of the indicator, preventing loss downstream.

Available for various sanitary Tri-Clamp process line sizes (3/4'', 1.0'', 1.5'', and 2.0''), it meets high pharmaceutical standards including U.S. Pharmacopeia Class VI Certification, Cytotoxicity Criteria, CFR Title 21 Section 177.2600, traceability, certification, ASME-BPE Standards, USDA Standards, 3-A Sanitary Standards, CGMP, and offers metal detectable elastomers without animal-derived ingredients.

The EZTest® biological indicator complies with U.S. Pharmacopeia, ISO 11138, and European Norm 866 standards. The gasket is also available with a Smart Gasket® Thermocouple Port for enhanced functionality. Rubber Fab Technologies Group holds patents and trademarks related to these products. For more information on inline system validation products, visit their website.

Rubber Fab Technologies Group is located at 26 Brookfield Drive, Sparta, NJ 07871, contactable via phone or fax, with additional technical details available upon request.

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Description

Rubber Fab introduces the Smart Gasket®, a product that allows self-contained biological indicators to be used in sanitary process lines. It supports top loading or inline positioning of EZTest® indicators and temperature probes, offering faster results (24 hours) compared to traditional spore strips (5-7 days). The gasket ensures secure placement for easy retrieval and is available for various Tri-Clamp sizes, meeting high pharmaceutical standards.

Technical Information

  • File Format: PDF
  • File Size: 989 KB
  • Pages: 2
  • Language: EN
  • Total Downloads: 202
  • Last Updated: 1 month ago

Document Overview

This PDF document about Smart Gasket® for Biological Indicator Validation in Sanitary Process Lines provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into Smart Gasket® for Biological Indicator Validation in Sanitary Process Lines.

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Smart guideSmart tutorialGasket® guideGasket® tutorialBiological guideBiological tutorialIndicator guideIndicator tutorialValidation guideValidation tutorialSanitary guideSanitary tutorialProcess guideProcess tutorialLines guideLines tutorial

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