Vapor Phase API Sterilization Without Heat Degradation
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Solution Overview
Problem
The bioburden of active pharmaceutical ingredients (API) and the equipment used to process such ingredients is a significant concern, particularly for injectable or intravenous dosage forms, necessitating effective methods to reduce contamination while maintaining the integrity of the API.
Innovation Solution
A method involving vapor phase deposition with sterilization steps using ozone or H2O2 vapor, followed by inert gas purging, is applied to particles comprising an API, ensuring the bioburden is reduced by forming a metal oxide or metalloid oxide coating without exposing the API to high temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sterilization methods (autoclaving, dry heat) are used to reduce bioburden, then sterilization effectiveness is improved, but API degradation occurs due to high temperatures
Solution Approach 1:
The patent changes the sterilization parameters from high temperature (autoclave at 121°C or dry heat at higher temperatures) to low temperature chemical sterilization using ozone or H2O2 vapor at temperatures below 60°C, thereby achieving effective sterilization without causing API degradation
Solution Approach 2:
The patent employs strong oxidizing agents (ozone or H2O2 vapor) to achieve sterilization through oxidation of microorganisms and contaminants, providing effective bioburden reduction at low temperatures without requiring thermal energy that would degrade the API
2Productivity
If vapor phase deposition is performed without prior sterilization, then processing time is reduced, but bioburden contamination remains high
Solution Approach 1:
The patent merges the sterilization step with the vapor phase deposition process by performing both operations in the same reactor chamber without removing or transferring the particles, thereby achieving both bioburden reduction and coating application in a single integrated process that minimizes handling time and maintains productivity
3Ease of manufacture
If particles are removed from chamber after sterilization and reloaded for coating, then sterilization and coating can be performed separately, but handling time increases and contamination risk rises
Solution Approach 1:
The patent combines multiple process steps (sterilization, drying, and vapor phase deposition) into a single continuous operation within one reactor chamber, eliminating the need to remove and reload particles between steps, thereby reducing handling time and minimizing contamination risk while maintaining process flexibility
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 method effectively reduces bioburden by more than 80-90% while preserving the API's integrity, allowing for the application of thin coatings at low temperatures without degradation.
Implementation Method 1
The sterilization step comprises: injecting ozone into the chamber to reach a predetermined ozone concentration and holding for a predetermined period of time
Implementation Method 2
The sterilization step comprises: injecting ozone into the chamber to reach a predetermined ozone concentration and holding for a predetermined period of time
Implementation Method 3
applying a vaporous or gaseous metal or metalloid precursor to the particles in the reactor by pulsing the vaporous or gaseous aluminum precursor into the reactor
Implementation Method 4
applying a vaporous or gaseous metal or metalloid precursor to the particles in the reactor
Data Source
AI summary
The disclosure is directed at methods for reducing the bioburden of both particles comprising an active pharmaceutical ingredient (API) and the equipment used to process such particles.