In the past few decades, biopharmaceuticals and preparations have made breakthrough progress in improving the quality of life of people suffering from various major diseases and poor physical health. As the demand for such formulations gradually increases, it is crucial to reduce manufacturing costs and extend the service life of formulations without affecting product safety, quality, and efficacy. More and more biological products are being continuously researched in the form of lyophilization powder.

What Is Lyophilization, and Why Do We Need Freeze-drying Technology ?

Lyophilization is a key technology used to preserve the active ingredients of biological products, active pharmaceutical ingredients, vaccines, etc., extend their shelf life, and maintain their physicochemical stability through low-temperature freezing and vacuum sublimation dehydration.

The process of freeze-drying mainly consists of four steps: pre freezing, sublimation drying (primary drying), analytical drying (secondary drying), and sealed storage.The key material required for all processes is the breathable membrane.

Figure 1 Schematic diagram of freeze-drying disc principle

The following conditions should be met during the freeze-drying process:

·The curing temperature of the product is lower than its eutectic point;

·The sublimation drying temperature should be lower than its disintegration temperature;

·The analytical drying temperature should be lower than its glass transition temperature Tg.

The freeze-drying product can be stored at room temperature or refrigerated for a long time according to the above steps. When needed, it can be restored to its pre freeze-drying state by adding a suitable solvent for reconstitution.

Biological products that have undergone freeze-drying treatment can be stored for a long time, greatly reducing process losses and saving costs for enterprises.

What Materials Can Ensure the Safety of Biological Products During the Freeze-drying Process？

The vast majority of items in the food and biotechnology industry are stored using freeze-drying. However, due to the susceptibility of biological products to contamination by airborne bacteria, viruses, and other microorganisms during storage, the freeze-drying process is usually designed using a biosafety process. For highly pathogenic biological products (such as live virus vaccines), disposable freeze-drying trays and closed transport systems are used to avoid cross contamination. This type of freeze-drying tray must use a special material (freeze-drying membrane that combines isolation and breathability) to prevent cross contamination between air components and freeze-drying materials, and to meet the effective evaporation and escape of water molecules during the freeze-drying process to achieve pressure equilibrium. In order to ensure the long-term safety performance of biological products, the membrane used for freeze-drying must also have a certain strength. Based on the above points, Membrane Solutions developed a PTFE venting membrane material specifically for freeze-drying, which meets the urgent market demand for the safety of the freeze-drying process of biological products.

How Do PTFE Venting Membrane Actually Work in Freeze-drying Process?

PTFE venting membrane work through:

• Welding assembly - By welding shells of different materials to form components, biological samples are ensured to be leak free and isolated from external bacterial contamination, which requires venting membrane materials that are easy to weld;

•Sterilization treatment - The freeze-drying components assembled must undergo gamma irradiation or high-temperature and high-pressure sterilization treatment to prevent microorganisms in the components from affecting biological products. Therefore, it is required that the venting membrane must withstand gamma irradiation or high-temperature and high-pressure sterilization;

• Freeze drying exhaust - The product to be freeze-drying is placed in a freeze-drying component, and after low-temperature freeze-drying process, the material forms ice crystals, which sublimate and remove water vapor under vacuum conditions. This process requires materials with high air permeability to facilitate water vapor removal;

• Physical isolation - The entire freeze-drying cycle requires freeze-drying components to have a certain physical barrier effect on the external environment to prevent component damage, so venting materials need to have good strength.

At Membrane Solutions, our PTFE venting membrane technology provides highly efficient freeze-drying effect, offering both Radiation sterilization and moist heat sterilization membrane options tailored to your application.

What Makes Membrane Solutions PTFE Venting Membrane Stand Out?

In order to ensure the safety concerns of users during the transfer and storage process of biological products, the Maiborui R&D team has conducted experimental verification and found that the unique high-temperature composite technology combines e-PTFE membrane with PE/PP material. This membrane combines the high breathability of PTFE membrane with the strength and weldability of PE/PP material, fully ensuring the convenience of post-processing for back-end freeze-drying equipment manufacturers.

Figure 2 Freeze-drying membrane of MS

The main advantages of MS freeze-drying membrane are as follows:

·High air permeability: The high porosity of e-PTFE membrane ensures its air permeability;

·Good sterilization effect: adopting a unique membrane making process to ensure the uniformity of membrane pore size, thereby preventing contamination by particles, bacteria, microorganisms, etc;

·Strong compatibility: After thermal composite process design, the freeze-drying membrane can be assembled with various freeze-drying equipment;

·Good product stability: The simpler production process control makes mass production easier and can fully ensure the stability of product performance;

·Resistant to gamma irradiation and moist heat sterilization: After special membrane making process improvement, this freeze-drying membrane can withstand gamma irradiation sterilization methods that other e-PTFE venting membranes do not meet, while also meeting multiple moist heat sterilization requirements, which makes it easier for you to use;

·Good biocompatibility: This PTFE venting membrane can meet USP87 testing requirements. The materials used for this membrane are relatively safe for biological products, and we did not add any other ingredients during the processing, which ensures biological safety.

Figure 3: Advantages of MS Freeze Dried Membrane

Final Thoughts: Are PTFE Venting Membrane Worth It?

Yes, PTFE venting membrane is definitely worth it for any enterprise concerned about cost reduction and safety protection of biologics. With the intensification of market competition, finding suitable low-cost, high-efficiency, and high protective materials is the most critical measure for enterprises. Explore MS's biosafety protection technology and find products that meet your needs. We are here to help you significantly save costs and build a safe and high-value future.