GORE® LYOGUARD® Freeze-Drying Tray
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FREEZE-DRYING TRAYS Single-use disposable containers for bulk API lyophilization Protect and contain product during lyophilization Product Description GORE® LYOGUARD® Freeze-Drying Trays are fully enclosed, singleuse, disposable containers that use a unique ePTFE membrane technology to both prevent cross-contamination and fly-out, and enable the free exchange of moisture vapor during lyophilization. Vapor (water and solvents) escaping GORE™ ePTFE Membrane barrier Contaminants being repelled Spout Gore’s unique ePTFE membrane enables high efficiency lyophilization yet provides a barrier to product cross-contamination. The ePTFE tray surface is chemically inert, biocompatible and includes a convenient fill cap. The flexible, thin-film polypropylene tray bottom closely conforms to dryer shelves for efficient and uniform heat transfer. These autoclavable trays are designed to be direct replacements to open trays and are compatible with most freeze-drying processes. Common Applications • Bulk API lyophilization up to 1800 ml • Formulation research and development • Clinical phases and full scale manufacturing Material of Construction Product Contact Surfaces • Polypropylene • GORE™ expanded polytetrafluoroethylene (ePTFE) membrane Other External Materials • Polyester Regulatory Information The GORE® LYOGUARD® Tray is intended for use as a processing aid in the production of materials that are frequently subject to FDA regulation. The regulatory status of the end product resulting from a manufacturing process, such as a pharmaceutical, does not transform a manufacturing apparatus into a medical device. The GORE® LYOGUARD® Tray is neither classified nor regulated as a medical device. Key Features and Benefits Protective ePTFE barrier membrane • Offers high moisture vapor transmission rate • Developed for freeze-drying processes • Reduces product cross-contamination • Limits exposure to API with reduced fly-out • Reduces or eliminates freeze dryer cleaning costs • Provides optimized throughput with shorter cycle times Single-use, disposable trays fit standard freeze dryers • Enables the use of existing equipment during processing • Provides an alternative to tray covers or open trays Bio-compatible, chemically inert materials of construction • Suitable for pharmaceutical lyophilization Thin flexible bottom film and tray frame • Enables uniform and efficient heat transfer Tray Manufacturing Environment and Quality Assembly operations for the GORE® LYOGUARD® Trays are conducted in an ISO 8 clean room with particle monitoring to ensure that the room is operating to at least ISO 7 (class 10,000) during operation. Final inspection and packaging are conducted in a controlled environment. GORE® LYOGUARD® Freeze-Drying Trays are manufactured in a manner that adheres to relevant current Good Manufacturing Practices (cGMP), as defined in a quality system certified to ISO9001, ISO13485, and ISO15378. GORE® LYOGUARD® Trays are 100% visually inspected for d

LYOGUARD. FREEZE-DRYING TRAYS rSingle-use disposable containers for bulk API lyophilization GORE® LYOGUARD® Freeze-Drying Trays meet the requirements of the following: The details of test procedures and results are available in the GORE® LYOGUARD® Freeze-Drying Trays Validation Guide. Recommended Tray Fill Volume Maximum volume: 1800ml Minimum volume: 200 ml Chemical Compatibility All product contact surfaces are composed of polytetrafluoroethylene or polypropylene. Both polymers are chemically inert and have a high degree of compatibility with a variety of fluids. As with other processing...