Segregated Purification Sections for Faster Bioprocess Changeover
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Solution Overview
Problem
Conventional purification systems require extensive downtime for product-to-product changeover (PCO) due to the need to clean and sterilize all purification units, reducing the operational time and increasing costs in facilities that produce multiple biological materials.
Innovation Solution
A purification system with segregated purification sections, where airflow is blocked between sections, allowing simultaneous purification and maintenance in separate areas, enabling parallel processing and reducing PCO time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If all purification units are replaced, washed, and sterilized sequentially during PCO, then cross-contamination is prevented, but PCO time is excessively long
Solution Approach 1:
The purification facility is divided into multiple independent purification sections (first purification section, second purification section, third purification section) that can operate independently. Each section has its own purification units that can be maintained separately, allowing parallel operation and reducing overall PCO time while maintaining cross-contamination prevention through physical separation.
Solution Approach 2:
While purification units in one section are being maintained (replaced, washed, sterilized), other purification sections continue to perform purification operations without interruption. This parallel processing ensures continuous productive action across the facility, maximizing operational time and minimizing PCO downtime.
2Reliability
If purification facilities are dedicated to single biological material production, then manufacturing quality is ensured, but facility utilization efficiency decreases
Solution Approach 1:
The purification facility is designed with multiple purification sections that can handle different biological materials through systematic cleaning and sterilization protocols. Each section can be dedicated to specific material types while the overall facility serves multiple product lines, achieving both quality assurance and high utilization efficiency.
Solution Approach 2:
The facility uses controllable parameters such as airflow direction, pressure differentials, and sterilization conditions to transition between different biological material productions. By changing these parameters, the same physical infrastructure can safely produce different materials without cross-contamination, enabling high facility utilization while maintaining manufacturing quality.
Data Source
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AI summary
The present invention relates to a purification system and a method of purifying biological materials using same, the purification system comprising: (a) a first purification section comprising one or more purification units; and (b) a second purification section comprising one or more purification units and atmospherically segregated from the first purification section by blocking airflow therebetween. According to the purification system of the present invention, the time required for product-to-product change over (PCO) can be dramatically reduced, thus having the surprising effect of maximizing the operation time of a purification facility.