Powder Transfer System Cleaning via Segmented Backflush and Spray Cycles
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Solution Overview
Problem
Complex powder transfer systems face challenges in effective cleaning due to their complexity, leading to residual microbial and pharmaceutical contaminants, and existing clean-in-place (CIP) methods often leave behind residues, making fully automatic cleaning impractical.
Innovation Solution
A method involving a washing fluid source, spray device, backflush valve, and membrane filter is implemented, with sequential backflush and spray device cycles using different cleaning solutions and pressures to thoroughly clean the system, including a big bag station, ensuring thorough removal of residues without reintroducing contaminants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a fully automatic CIP system is employed, then cleaning efficiency and productivity are improved, but device complexity increases making it impractical for complex powder transfer systems
Solution Approach 1:
The receiving device is divided into an upper chamber and a lower chamber that are cleaned separately through different valves (backflush valve for upper chamber, spray device valve for lower chamber). This segmentation allows the complex cleaning task to be broken into manageable parts that can be handled by simpler, dedicated cleaning mechanisms for each section.
Solution Approach 2:
The backflush cycle reverses the normal flow direction by flushing fluid from the washing fluid source through the upper chamber in reverse flow direction. This inversion of cleaning approach allows effective removal of residues from the upper chamber without requiring complex disassembly or manual intervention.
2Reliability
If conventional CIP methods are used, then cleaning is performed, but manufacturing residues and cleaning solution residues remain behind reducing reliability
Solution Approach 1:
The cleaning process uses periodic alternating cycles of backflush and spray device operations, with multiple sequential steps including prewash, main wash, and rinse phases. This periodic action ensures thorough cleaning by repeatedly exposing different areas to cleaning fluid at different times, preventing residue accumulation.
Solution Approach 2:
A membrane filter is introduced as an intermediary component between the upper and lower chambers. This filter not only separates the chambers but also serves as a cleaning target itself, being backflushed to remove residues. The filter acts as a mediator that prevents cross-contamination while allowing effective cleaning of both chambers.
3Manufacturing precision
If the upper and lower chambers are cleaned together, then cleaning time is reduced, but cleaning precision decreases allowing contaminants to be reintroduced
Solution Approach 1:
The receiving device is divided into an upper chamber and a lower chamber that are cleaned separately through different valves (backflush valve for upper chamber, spray device valve for lower chamber). This segmentation allows the complex cleaning task to be broken into manageable parts that can be handled by simpler, dedicated cleaning mechanisms for each section.
Solution Approach 2:
The backflush cycle is performed first to clean the upper chamber and membrane filter before the spray device cycle cleans the lower chamber. This preliminary action prevents potential cross-contamination by ensuring the upper chamber is cleaned and sealed off before cleaning the lower chamber, maintaining cleaning precision throughout the process.
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 removes manufacturing residues and cleaning solution residues, meeting pharmaceutical industry standards by using a combination of fluid dynamics and mechanical principles, creating an air barrier to prevent re-introduction of contaminants and enhancing cleaning action.
Implementation Method 1
opening the backflush valve to initiate a backflush cycle, running the backflush cycle to wash the upper chamber with a fluid from the washing fluid source
Implementation Method 2
opening the spray device valve to initiate a spray device cycle, running the spray device cycle to wash the lower chamber with a fluid from the washing fluid source
Implementation Method 3
a membrane filter disposed between the upper and lower chambers
Implementation Method 4
opening a pressure valve to provide a processed control air (PCA) to the receiving container
Implementation Method 5
running the backflush cycle to wash the upper chamber with a fluid from the washing fluid source
Implementation Method 6
agitating the washing fluid in the bag body
Data Source
AI summary
A method of cleaning a complex powder transfer system including providing a powder transfer system having a washing fluid source, a spray device valve in fluid communication with the washing fluid source, a backflush valve in fluid communication with the washing fluid source, a receiving device having an upper chamber, a lower chamber, and a membrane filter disposed between the upper and lower chambers. The method includes opening the backflush valve to initiate a backflush cycle, running the backflush cycle to wash the upper chamber with a fluid, and closing the backflush valve after the backflush cycle completes. The method includes opening the spray device valve to initiate a spray device cycle, running the spray device cycle to wash the lower chamber with fluid, and closing the spray device valve after the spray device cycle completes. The method includes opening a pressure valve to provide PCA to the receiving container.