Yingtai: Advantages of Vacuum Freeze Drying Technology in Biopharmaceuticals

Yingtai: Advantages of Vacuum Freeze Drying Technology in Biopharmaceuticals

(1) The application of vacuum freeze drying technology can compensate for the shortcomings of traditional drying methods, improving the drying effect and ensuring the final product quality.

(2) Traditional drying methods often cause issues such as wrinkling and breakage of the product during drying. However, vacuum freeze drying technology uses the sublimation of solids into gases, preventing excessive damage to the material and effectively protecting the biological structure.

(3) Since this technology operates in a completely vacuum environment, it avoids contamination and the presence of unnecessary impurities, making it easier to transport. This provides a solid foundation for the widespread application of biopharmaceuticals.

1. Selection of Freeze Dryer Performance
The freeze dryer is a critical component for implementing vacuum freeze drying technology. When applying this technology to biopharmaceuticals, it is essential to analyze and choose the freeze dryer performance based on the pharmaceutical production and processing requirements, ensuring the selection of the best equipment according to the corresponding standards.

When making this selection, the following issues should be considered: (1) The specifications, capacity, and shelf dimensions of the freeze dryer must align with the actual production volume.

(2) Ensure that the front and back surfaces of the shelves are smooth, maintaining uniform temperature across the shelves. The temperature difference between any point on the shelf and between different shelves should stay within the required range to ensure uniform quality for the entire batch.

(3) Ensure the condenser temperature can drop to the required temperature within 2-5 hours, not exceeding 45°C.

(4) The vacuum level of the chamber should be tested using an empty chamber test, ensuring that it can reach 2.66Pa within 30 minutes. This creates the required environment for subsequent drying processes. To prevent steam condensation, vacuum leakage from the condenser and freeze dryer chamber, etc., a leakage test should be conducted on the pressure-bearing components inside and outside the equipment to avoid contamination of the pharmaceutical products.

(5) Since biopharmaceuticals are particularly sensitive, the design of the chamber should be reasonable. It is recommended to choose stainless steel materials and adopt scientific design methods to ensure easy cleaning and corrosion resistance. To prevent pharmaceutical raw materials from corroding the chamber and its components, careful selection of materials for pipes, the freeze dryer chamber, and shelves is necessary. To facilitate later cleaning, the internal structure of components should be kept simple, reducing the number of parts while ensuring proper functionality.

(6) To ensure that the minimal material cleanliness, ease of cleaning, and gas discharge volume meet the required standards in the vacuum environment, the surfaces of the shelves and freeze dryer chamber should undergo mirror polishing to guarantee optimal drying performance.

2. Advantages of Yingtai Freeze Dryers
Yingtai pilot-scale freeze dryer technical advantages:

(1) Shelf empty-load cooling rate: +20°C to -40°C ≤ 60 min
(2) Shelf empty-load heating rate: ≥ 1°C/min (chamber vacuum < 1Pa)
(3) Shelf empty-load temperature uniformity: ≤ 1°C (When the temperature reaches equilibrium, the temperature difference between different points on the shelf at -40°C, 0°C, and 40°C should be within 1°C)
(4) Shelf flatness: ≤ ± 0.4mm/m²
(5) Shelf roughness: Ra ≤ 0.3μm
(6) Heat transfer oil control precision: ≤ ± 1°C