LYOPHILIZATION APPARATUS WITH ENHANCED EFFICIENCY

Abstract

The invention discloses an improved lyophilization apparatus that enhances efficiency, reduces processing time, and ensures product quality. It features a modified chamber design with multi-tier shelves for maximum space utilization and uniform vapor flow. The shelves have coated heat transfer surfaces for superior thermal conductivity and reduced product adhesion. An advanced thermal control system with thermoelectric modules and liquid circulation ensures precise and rapid temperature zoning. A high-efficiency condenser with specialized fin structures and alloys enhances heat transfer and vapor removal. The refrigeration cycle uses multi-stage compression and advanced refrigerants for stable low temperatures. The system is managed by intelligent process software with adaptive algorithms, employs real-time monitoring and machine learning to optimize the lyophilization cycle. A multi-stage, oil-free vacuum system ensures contamination-free operation. The method automates phase transitions and integrity tests, significantly reducing lyophilization time compared to conventional systems.

Specification

Description:The lyophilization apparatus (100) of the invention features a modified chamber design (101) that includes a multi-tier shelf 108 configuration. The multi-tier shelf 108 arrangement allows maximum utilization of the available area while helping to vaporize a uniform flow at all locations during the drying process and removes bottlenecks in a conventional system. Heat transfer surfaces (102) on each shelf have been provided with specific surface coatings so that it exhibits excellent thermal conductivity and disallow any product attachment on these shelves, thus allowing equal heat conduction throughout all vials during the several drying phases.

It also features an advanced thermal control system 103, which consists of thermoelectric modules and liquid circulation channels. This module maintains fast and precise temperature zoning across the different shelves. The thermal control system 103 is in stabilizing product temperatures through the freezing, primary, and secondary drying phases.

There is a high-efficiency condenser 104 in the apparatus. This condenser has an advanced fin structure that is made of special alloy so that the heat transfer surface 102 efficiency becomes very high. The vapor removal efficiency is at its best with this and enhances the lyophilization process further. This apparatus is integrated with the improved refrigeration cycle 105, which has multi-stage compression systems and advanced refrigerants. It takes care to maintain optimal temperature conditions at every phase. Energy consumption in processing is minimized the speed in overall processing is also enhanced.

The apparatus includes intelligent process management software (106) using real-time monitoring for parameters such as shelf temperature, chamber pressure, and vapour flow. Adaptive control algorithms (107) by the software self-adjust the operating conditions with a view to optimizing the lyophilization cycle for maximum effectiveness based on real-time data. It employs machine learning techniques that predict the right time for phase transitions and improves the process continuously based on historical performance data.

The complete operation is further streamlined with the automated controls, which manage the transition from the freezing, primary drying, and secondary drying phases without the need for manual intervention. The software also includes multi-stage, oil-free pump configuration operating in tandem with intelligent control algorithms to provide sustained vacuum during the cycle.

The utility cycle for the lyophilizer assembly is therefore proposed as a series of steps rather tightly controlled. For this purpose, vials of the product are loaded onto a multi-tier shelf arrangement within the modified chamber design (101). When the vials are loaded, the lyophilisation cycle is initiated and entirely controlled by the intelligent process management software 106. In this way, constant real-time monitoring is ensured to guarantee that all of the critical parameters are falling in the desired range in the course of the process.

High-efficiency system continuously varies shelf temperatures and chamber pressure to exactly satisfy process demands, hence highly improving the uniformity of the product. The removal of vapor is very critical in the condenser as high efficiency system helps ensure phases of drying are performed as fast as possible. Once the final phase of drying is accomplished, the apparatus performs automated integrity tests prior to breaking the vacuum and recovery of the product, thus ensuring quality of batches and reducing the possibility of contamination.

Embodiments
1. Modified chamber design (101) and Shelf Configuration
Improved lyophilization apparatus (100) includes a modified chamber design (101) which saves precious space and improves the overall processing efficiency. The chamber further provides a new multi-tier shelf (108) configuration which allows it to accommodate more product vials than a single cycle.

In the multi-tier shelf 108 configuration, all levels have heat transfer surfaces 102 that are made of a high-conductivity material, such as an aluminum alloy with a special coating, so that fast and uniform heat distribution is achieved. The application of a coating for this surface also has the advantage of acting as a non-stick layer to prevent product contamination, and is relatively easy to clean.

The shelves have been designed to optimize spacing for both efficient flow of vapors and accommodation of varied sizes of vials. This is important in ensuring that all the product units have a uniform drying rate. The shelves are mounted on a well-designed light structure which minimizes thermal mass. Therefore, with the change in temperature, when changing from one phase of lyophilization to another, it shall be faster.

2. Advanced thermal control system (103)
This apparatus includes an advanced thermal control system 103. The use of the apparatus is further empowered by integration of precision temperature sensors and heating/cooling elements into each shelf of the apparatus. It gives the possibility of having precision temperature zoning across the chamber, making conditions in one area of the apparatus to be designed towards freeze-drying.

A hybrid approach uses both thermoelectric modules and liquid circulation channels within the shelves. This type of configuration is deliver rapid response for fine-tuned temperature control and stable long-term temperatures. Thermoelectric modules are used for faster response to fine temperature control whereas high thermal loads are handled efficiently by liquid circulation systems.

All heating and cooling units are controlled by a central thermal management unit. These units are connected to the intelligent process management software 106 so that temperature is dynamically adjusted according to real-time process data.

3. High-Efficiency Condenser
The high efficiency condenser is such as important component for reducing lyophilization time. This features increased surface area with a new fin arrangement, thus maximizing the ability to collect ice while keeping air flow resistance as low as possible. Condenser coils made from a special alloy are established to ensure the possible efficiency for heat transfer.

The improved refrigeration cycle 105 incorporated with the condenser includes a multi-stage compression system and advanced refrigerants. This enables the condenser to achieve extremely low temperatures of up to -80°C or lower efficiently, even in vapor load conditions as high as those experienced during the primary phase of drying.

This condenser comes with an integrated defrosting mechanism. In this a heating element and a warm gas bypass are used to rapidly defrost the condenser between cycles; thereby, reducing down time and overall system productivity.

4. Intelligent Process Management Software 106
The intelligent process management software (106) is the thinking brain of the freeze dryer. It implements a real-time monitoring through a network of sensors placed at locations within the chamber. These sensors monitor on-line, in real time, critical parameters such as:
Temperature at multiple points on each shelf and inside sample vials.
Pressure is within the modified chamber design 101.
Moisture content is in the chamber atmosphere.
Condenser is ice accumulation.
Product resistance and temperatures.

The software uses adaptive control algorithms (107) that update real-time information. The described algorithms make use of machine learning approaches to the dynamic optimization of lyophilization cycle. For example, the software alters shelf temperatures and adjusts chamber pressure in response to product resistance variability during the drying stage in a manner that ensures high sublimation rates without risking product collapse.

5. Vacuum System
The vacuum system has maintained low pressures stable under conditions of high vapor loads. It adopts a multi-stage design with oil-free technology in the bid to avoid contamination of the product.

The vacuum system offers integration with intelligent control software to ensure accurate pressure control during the lyophilization cycle. This integration allows such challenging techniques as a pressure rise test to perform end-point determination in a way that does not break up the course of drying.

6. Vapour Flow Optimization
The modified chamber design (101) has appropriately engineered pathways in the form of paths for the vapor movement from the product shelves towards the condenser. These are optimized using computational fluid dynamics to provide the least resistance to the flow of vapor. Optimization is done by:
• Strategically placed baffles
• Internal polished surfaces to reduce turbulence
• Optimized geometries of the chamber to avoid dead zones

7. Rapid Heating and Cooling System
This technique of fast heating and cooling is achieved by a combination of technologies, such as the following:
- High-performance fluid circulation system with suitable heat transfer fluid
- Thermoelectric modules for precise temperature control
- Radiation shields to allow minimal transfer of heat between shelves
This equipment is for rapid changes between various lyophilization stages, particularly optimization of the freezing step and the induction of primary drying.

8. Safety and Monitoring Features
There are several safety and monitoring elements in the equipment:
-Redundant temperature and pressure transmitters for fail-safe operation
-Program controlled emergency shutdown protocols
-In real-time alerts and notifications for off-spec processes
-Data logging and batch record generation in compliance

The method of performing the invention:
1. Place the product flasks on the multi-tier shelf and distribute the loads evenly.
2. Activate the cycle of lyophilization by the intelligent process management software 106.
3. It invokes optimized freezing protocol, relying on rapid cooling effects to provide equal ice crystals formation.
4. Automatic transition from freezing to primary drying is founded on temperature sensors and pressure rise tests.
5. Primary shelf temperature, along with the chamber pressure, is adjusted in real time based on the product's data through adaptive control algorithms 107.
6. High-efficiency condenser 104 maintains optimal vapor-removal rates at all stages.
7. Secondary drying is automatically initiated by the software once it determined that ice sublimation is complete.
8. Once a cycle is complete, the system is an integrity test that opens the vacuum for product recovery.
, Claims:1. A lyophilization apparatus 100 comprising:
a modified chamber design (101) with a multi-tier shelf 108 configuration;
enhanced heat transfer surfaces (102) on each shelf;
an advanced thermal control system (103) enabling precise temperature zoning;
a high-efficiency condenser (104) with increased surface area;
an improved refrigeration cycle (105);
intelligent process management software (106) utilizing real-time monitoring; and
adaptive control algorithms (107) for process optimization;
wherein the combination of these elements results in reduced lyophilization processing time while maintaining product quality.

2. A method for lyophilisation apparatus as claimed in claim 1, comprising the steps of:
loading product vials onto a multi-tier shelf configuration within a modified chamber design (101);
initiating a lyophilization cycle controlled by intelligent process management software (106);
continuously monitoring process parameters through real-time monitoring;
dynamically adjusting shelf temperatures and chamber pressure using adaptive control algorithms (107);
efficiently removing vapour using a high-efficiency condenser 104; and
automatically transitioning between freezing, primary drying, and secondary drying phases;
wherein the method significantly reduces lyophilization time compared to conventional processes.

3. The apparatus as claimed in claim 1, wherein the multi-tier shelf 108 configuration is optimized for maximum space utilization and uniform vapour flow.

4. The apparatus as claimed in claim 1, wherein the enhanced heat transfer surfaces 102 comprise a specialized coating for improved thermal conductivity and reduced product adhesion.

5. The apparatus as claimed in claim 1, wherein the advanced thermal control system 103 includes thermoelectric modules and liquid circulation channels for rapid and precise temperature control.

6. The apparatus as claimed in claim 1, wherein the high-efficiency condenser 104 includes a fin arrangement and is made of a specialized alloy for enhanced heat transfer.

7. The apparatus as claimed in claim 1, wherein the improved refrigeration cycle 105 comprises a multi-stage compression system and advanced refrigerants.

8. The apparatus as claimed in claim 1, wherein the intelligent process management software 106 employs machine learning techniques for optimizing the lyophilization cycle.

9. The apparatus as claimed in claim 1, further comprising a vacuum system with multi-stage, oil-free pump configuration integrated with the intelligent control software.

10. The method as claimed in claim 2, further comprising the step of performing automated integrity tests before breaking a vacuum and retrieving the product.

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