The key concept of lyophilization is sublimation – a process where a substance changes from a solid to a vapor without passing through a liquid phase. When comparing freeze-dried products with their liquid counterparts, they have:
2. What are the steps of freeze-drying?
Freeze-drying consists of three major process steps:
The steps of the process will be dependent upon the nature of the product being lyophilized. The freeze-drying cycle parameters for each product will vary depending upon the freezing and drying behavior of each product. The success of the overall process is dependent upon proper definition and execution of each step.
3. What are the materials of construction for both the GORE™ LYOGUARD® Tray and Container?
These completely enclosed, single-use, autoclavable lyophilization products are constructed of polypropylene and expanded polytetrafluoroethylene (ePTFE).
The microporous ePTFE membrane is incorporated into the top surface of the tray and container, protecting the product inside from cross-contamination and reducing fly-out. The tray has a convenient fill port and the container has a removable screw-top for ease of filling.
The flexible, thin-film polypropylene bottom closely conforms to dryer shelves for efficient and uniform heat transfer.
4. What is the significance of the Gore ePTFE membrane barrier?
Expanded polytetrafluoroethylene membrane provides the perfect balance between vapor transmission rate and barrier properties. This proprietary combination of attributes enables product to be properly contained and protected with minimal drying cycle extensions.
The ePTFE membrane surface is:
5. Do existing processes need to be modified?
GORE™ LYOGUARD® Freeze-Drying Trays can be used as a direct replacement for open stainless steel trays and/or other lyophilization containers and are compatible with most freeze-drying processes. Manufacturers are able to improve sterility assurance, reduce product loss and improve throughput with minimal or no change to existing processes.
6. How will cost savings be realized from using GORE™ LYOGUARD® Freeze-Drying Products?
The greatest cost savings come from increased product yields and decreased cleaning and cleaning validation costs. Additional savings may be possible through risk reduction, increased capacity, or process improvements. GORE™ LYOGUARD® Freeze-Drying Products create a safe environment by providing an effective barrier between the product and the worker.
Many of today's pharmaceutical products in development are more potent than earlier generations, posing challenges in current manufacturing facilities. In response to these challenges, manufacturers are choosing to adopt new processes or invest in new capital equipment and facilities in order to meet compliance. GORE™ LYOGUARD® Freeze-Drying Products can be a part of an integrated program to properly handle these products, offering an effective alternative to costly facility upgrades.
7. What impact will GORE™ LYOGUARD® Freeze-Drying Products have on throughput?
GORE™ LYOGUARD® Freeze-Drying Products increase throughput by increasing yields and reducing overall processing times. Reduced cycle times have been seen in faster freezing, faster drying and faster tray loading due to the absence of spilling. Additional production capacity can also be gained by reducing or eliminating cleaning and/or sterilization or the freeze-dryer.
8. How do GORE™ LYOGUARD® Trays compare to tray wraps and barrier isolators?
Improvised tray wraps offer minimal product protection and containment. Significant cycle-time extensions and product melt-back due to poor vapor transfer properties are common.
Barrier isolators require a major capital investment, extensive validation and can be difficult to work with.
Neither tray wraps nor barrier isolators can match the unique combination of advantages provided by GORE™ LYOGUARD® Freeze-Drying Trays.
9. How can GORE™ LYOGUARD® Freeze-Drying Products be used for storing and transporting products?
To prevent the ingress of moisture, GORE™ LYOGUARD® Freeze-Drying Trays can be sealed in a foil pouch. Once heat-sealed in the foil pouch, the trays can be returned to the original shipping container for intermediate storage and transportation. Contact your local Gore sales representative for more information ordering foil pouches.
10. In what condition should GORE™ LYOGUARD® Products be stored?
The trays and containers should be stored in a controlled environment, similar to those found in an air conditioned office or lab environment.