Flexible Bag Lyophilisation System for Uniform Drying
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Solution Overview
Problem
Conventional lyophilisation trays face issues with cross-contamination, fragility, limited capacity, non-uniform freezing, and high costs, particularly the Lyoguard trays, which are prone to membrane damage and have limited capacity, making them unsuitable for large-scale or high-potency product lyophilisation.
Innovation Solution
A flexible-walled bag system for lyophilisation that includes a filling port, capable of containing products with a thickness ranging from 0.1 μm to 500 μm, made from robust materials resistant to low temperatures and sterilisation, with optional multi-layer construction for enhanced barrier and moisture transmissivity properties, allowing for efficient and uniform drying of products up to 5 kg or more.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional steel or plastic freeze dryer trays are used, then cross-contamination risk increases and cleaning time increases, but tray strength and reusability are maintained
Solution Approach 1:
The patent employs disposable trays made from flexible, biodegradable materials that are discarded after a single use, eliminating the need for cleaning and sterilization between batches. This resolves the contradiction by accepting single-use limitation (short-living) to achieve zero cross-contamination risk and zero cleaning time, while the low cost and biodegradability make the approach economically and environmentally viable.
Solution Approach 2:
The trays are constructed from flexible, thin-film materials that can be disposed of after use, providing a clean surface for each batch without requiring cleaning. The flexibility and thin-film nature enable easy disposal while maintaining sufficient strength during the lyophilisation process, thus eliminating cross-contamination risks and cleaning time requirements.
2Reliability
If Lyoguard trays with water permeable membranes are used, then moisture egress is enabled, but membrane fragility and capacity limitations occur
Solution Approach 1:
The trays are made from composite materials combining flexibility, strength, and biodegradability properties. These composite materials provide sufficient structural integrity to resist damage during handling and use, while also enabling effective moisture egress through their inherent permeability characteristics, thus resolving the contradiction between membrane strength and moisture egress capability.
Solution Approach 2:
By using disposable trays, the patent eliminates the need for fragile, reusable membranes that require repeated cleaning and sterilization. The single-use nature removes the cumulative damage issue, allowing optimal moisture egress design without compromising on durability, as each tray is used once and then discarded.
3Productivity
If larger capacity trays are used, then productivity increases, but uniform freezing and drying become more difficult
Solution Approach 1:
The flexible trays can adapt their shape and conform to the product load, changing the physical parameters of the drying surface. This flexibility allows large capacity trays to maintain uniform contact with the product, ensuring even heat and mass transfer across the entire surface area, thus achieving uniform drying despite increased capacity.
Solution Approach 2:
The trays transition from a static, rigid structure to a dynamic, flexible structure that adapts to the product being processed. This dynamic characteristic enables the tray surface to conform to varying product shapes and volumes, maintaining uniform drying conditions across the entire surface area regardless of the total capacity or load size.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The flexible bag system minimizes contamination risks, ensures uniform drying, and supports large-scale lyophilisation with reduced costs, maintaining product viability and efficiency comparable to or exceeding that of conventional Lyoguard trays, while being more cost-effective and resistant to damage.
Implementation Method 1
the pressure to which it is exposed is reduced, and a moderate amount of heat is applied, which causes the frozen water present in the product to sublime
Implementation Method 2
In the third phase, desorption, the temperature is increased to remove any non-frozen water molecules present in the product
Implementation Method 3
a condenser to remove moisture from the freeze dryer by condensation
Implementation Method 4
a vacuum pump to reduce the pressure in the dryer
Data Source
AI summary
The present invention relates to a process for lyophilising a product (3), comprising the steps of providing a bulk product (3) loading system in the form of a bag (1), the bag (1) having an interior and an exterior defined by a flexible wall, the bag (1) further comprising a filling port (5) providing access to the interior of the bag (1), filling a product (3) having a first moisture content into the interior of the bag (1) via the filling port (5), and exposing the product (3) in the interior of the bag (1) to a lyophilisation cycle such that the moisture content of the product (3) is reduced from the first moisture content to a second, lower, moisture content.