Contained Vacuum Crystallization for Pharmaceutical Purity
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Solution Overview
Problem
Conventional methods for producing highly purified metal salt hydrates, such as Manganese(II) chloride tetra-hydrate and Sodium molybdate di-hydrate, fail to meet the standards of the pharmacopeia for pharmaceutical applications due to contamination risks and instability issues, particularly in parenteral preparations.
Innovation Solution
A new manufacturing method involving vacuum crystallization combined with a drying process using a condenser trap to remove solvent, ensuring aseptic and ultra-clean conditions, and controlling temperature and pressure to prevent re-dissolution of crystal cakes, allowing for the production of highly pure metal salt hydrates in a contained vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional crystallization methods are used, then crystal production is achieved, but purity and pharmaceutical standards are not met due to contamination
Solution Approach 1:
The patent applies vacuum conditions (inert environment) throughout the crystallization and drying process to prevent contamination from atmospheric oxygen and carbon dioxide. The vacuum environment ensures that no external contaminants can enter the system, guaranteeing pharmaceutical-grade purity of the metal salt hydrates produced.
Solution Approach 2:
The patent replaces conventional mechanical filtration and manual handling with a contained vacuum crystallization system that produces crystals directly in a sterile environment. This substitution of mechanical separation methods with vacuum-based crystallization and drying eliminates contamination risks associated with manual handling and filtration equipment.
2Manufacturing precision
If vacuum crystallization is used, then purity is improved, but device complexity increases
Solution Approach 1:
The patent combines multiple functions into a single integrated vacuum crystallizer system that performs crystallization, filtration, and drying operations sequentially without requiring separate equipment. The vacuum environment is maintained throughout all operations, eliminating the need for multiple sealing systems and complex transfer mechanisms between different equipment pieces.
3Manufacturing precision
If conventional drying methods are used, then solvent removal is achieved, but re-dissolution of crystal cake occurs
Solution Approach 1:
The patent maintains vacuum conditions throughout the drying process to prevent re-dissolution of the crystal cake. The vacuum environment creates a pressure gradient that prevents solvent vapor from condensing and re-dissolving the crystals, while also preventing contamination from atmospheric moisture.
Solution Approach 2:
The patent utilizes controlled phase transitions of the solvent during drying. By maintaining vacuum conditions, the solvent evaporates directly from the crystal cake without passing through a condensation phase that would cause re-dissolution. The vacuum prevents the reverse phase transition, ensuring stable crystal structure.
4Reliability
If aseptic conditions are maintained, then contamination is prevented, but process complexity increases
Solution Approach 1:
The patent uses vacuum conditions as an inert environment that inherently prevents contamination from atmospheric sources. The vacuum state eliminates oxygen and carbon dioxide that could cause oxidation or carbonation of the metal salts, while also preventing entry of microorganisms and particulate contaminants.
Solution Approach 2:
The vacuum system automatically maintains aseptic conditions without requiring additional active contamination control systems. The vacuum environment self-regulates by preventing entry of contaminants and maintaining stable conditions throughout the process, eliminating the need for complex sterilization equipment and procedures.
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
This method enables the reliable production of pharmaceutical-grade, highly pure metal salt hydrates that meet GMP standards, ensuring homogeneity and purity, and avoiding contamination, thereby addressing the limitations of conventional methods.
Implementation Method 1
solvent from the crystal cake is frozen in the condenser trap and thereby removed from the crystal cake
Implementation Method 2
applying vacuum to a vessel containing a solution of the substance to be crystallized to start crystallization
Implementation Method 3
Crystallization is conventionally referred to as a process of the formation of solid crystals, precipitating from a solution or melt
Data Source
AI summary
The present invention relates to means and methods for producing crystals or crystalline substances in a contained vessel. In particular, crystals or crystalline substances, which are useful as pharmaceutical ingredients, can be manufactured.