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.

GORE STA-PURE Pump Tubing Series PFL enables reliable peristaltic pump operation in critical pharmaceutical and biopharmaceutical processing applications that include aggressive chemicals.

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 embossed version of this product with no printing ink on the sheet. 

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

A 113°C (235°F) maximum service temperature, lightweight, spunbonded polyester filter cartridge for use in pulse-jet style dust collectors.

GORE STA-PURE Pump Tubing Series PCS is a durable, resilient tubing product used in peristaltic pumps and is suitable for pharmaceutical and biopharmaceutical manufacturing. The product delivers consistent flow rate and low incidence of rupture, even at operating pressures up to 100 pounds per square inch gauge (psig), thus enabling the pump to work reliably under challenging conditions.

This document is available upon request.