GORE LYOGUARD Freeze-Drying Trays are fully enclosed, single-use, disposable containers that use expanded polytetrafluoroethylene (ePTFE) membrane technology to contain and protect liquid or lyophilized active pharmaceutical ingredient (API) during the entire freezedrying process.

This certificate is based on the test program of TÜV Anlagen- und Umwelttechnik or VDI 2440, November 2000 edition, which covers qualification testing of flange seals with respect to their leak rate, blow-out resistance and continuous functionality and verification of sealing characteristics and controlled production quality. The above points were verified in an initial test. Prerequisite is the use of flange systems made of steel, which, when installed, achieve or exceed minimum surface pressure.

Bright, reliable lighting can dramatically enhance the enjoyment – and safety – of public and commercial spaces and transitways. People feel safer and more secure when the places they park and walk have bright, working luminaires. But over time, environmental factors can degrade the luminaire’s original level of Ingress Protection (IP). This will allow damaging moisture and contaminants to enter the enclosure.

The Federal Institute for Materials Research and Testing (BAM) tests the sealing material compatibility for use in flanged connections with liquid and gaseous oxygen. Further information on the test procedure and the result can be found in the following test report. Please note that the test was conducted on the version of this product with no adhesive backing.

CAUTION: Extra care is advised to ensure that the gasket surface is free from particulate contamination that accumulates due to static charge.

Autoclave sterilization guidelines for GORE LYOGUARD Freeze-Drying Trays

This certificate is based on the test program of TÜV Anlagen- und Umwelttechnik or VDI 2440, November 2000 edition, which covers qualification testing of flange seals with respect to their leak rate, blow-out resistance and continuous functionality and verification of sealing characteristics and controlled production quality. The above points were verified in an initial test. Prerequisite is the use of flange systems made of steel, which, when installed, achieve or exceed minimum surface pressure.

Recommendations for tray handling during filling, dryer loading/unloading, product sampling and removing or reconstituting dried product.

A 135°C (275°F) maximum service temperature, stayed-polyester felt filter cartridge for use in pulse-jet style dust collectors where high differential pressure and high cleaning pressures are required due to aggressive dust loading.

GORE Gasketing products are comprised of expanded polytetrafluoroethylene (ePTFE), an inert fluoropolymer material. Some of these products may be supplied adhesive backed or screen printed. 

GORE® GR Sheet Gasketing has received a PDA (Product Design Assessment) certificate under the ABS Approval Program. The scope and limitations of this assessment are detailed on the pages attached to this certificate.