By Niall Deans
Technical Sales Manager
• A leading Dublin based biopharmaceutical facility experienced problems involving leakage from titrant header valves on a critical process line.
• The location of the process line means it is difficult to maintain.
• Problems remained unidentified until scheduled preventative maintenance windows.
• Diaphragm valves were replaced with ITT EnviZion valves which eliminated the leaks from the process line.
• A new switch pack was installed which costed 50% less than the original switch pack.
• The installation of ITT EnviZion valves eliminated the need for unscheduled maintenance and allowed maintenance to be completed within a shorter timeframe
A leading Dublin based biopharmaceutical facility experienced a number of problems on a critical process line involving leakage of titrant from a number of key diaphragm valves. This is a shared line which makes it difficult to schedule a maintenance window to replace the diaphragms. Compounding this problem, following the replacement of the diaphragms they usually started to leak within 3-6 months. The titrant is sodium carbonate which is used for PH control as part of the Clean-in-Place (CIP) operations in the bioreactors. The titrant repeatedly leaked forming large alkaline deposits of white residue around the valves at all nine titrant drops. Drip trays were installed by the client to provide a short-term solution to the problem. However, a permanent solution was required to solve the problem as part of Good Manufacturing Practice (GMP). The titrant header valves had multiple issues in relation to seal reliability and they required frequent unplanned corrective maintenance. As the diaphragm valves involved were in use for many years in a highly demanding area, they were damaged and worn and they longer functioned as intended by the manufacturer.
Valve Blocks Assessed Drain Angles Excessive Residue
Following consultation with the client, the installation of ITT EnviZion valves was proposed as a solution to the problem. A number issues needed to be addressed in relation to the valves performance characteristics and the installation of new valves into existing pipework. Performance criteria included achieving functional equivalency of the previous valves such as matching flow rates, enhanced cleanability, and reliability improvements such as improving first time maintenance, decreasing maintenance time and extending preventative maintenance intervals. In order to meet these performance criteria, Induchem Group, in consultation with ITT, recommended ITT EnviZion valves which have been proven in the field to solve all of the problems encountered by the facility. This new valve technology enables tool free installation and diaphragm replacement. Diaphragm changes are reduced from an industry average of 23 minutes down to 3 minutes, a 90% reduction in maintenance time. The ITT EnviZion valve, both actuated and manual, is particularly beneficial for use in chemical distribution systems, CIP skids and other systems with limited maintenance windows in difficult to access locations. In terms of the installation considerations involved, Induchem Group and ITT engineers had to ensure that the new hardware would fit in the space available and match the existing pipework connections. This involved 3D modelling, drawings consultation and extensive physical checks before the new valve designs were finalized. The ITT EnviZion valves were specified to match the existing installations flow chart characteristics ensuring cleaning and process systems remained unaltered. This revolutionary valve technology, as well as allowing diaphragm changes to be completed in less than five minutes, also utilizes a unique sealing system which maintains full reliability even if subjected to extensive thermal cycling during lengthy preventative maintenance intervals.
Results & Conclusion
Induchem Group and ITT completed this project within the timeframe requested by the client without any impact on production. A new passivation plug was installed which provided double isolation during the passivation of new welds and enabled the operation of other bioreactors during the project. The project facilitated the replacement of a valve block where the lines from two titrant headers converge on a bioreactor. This improved reliability prevented the further accumulation of excessive caustic residue. The replacement of the existing obsolete switch packs with new switch packs enhanced the overall reliability of the installation. Furthermore, the improvement of valve orientation and the use of new valve technology enables tool free maintenance on titrant drops which reduces the time required to complete elastomer change outs. The client received overwhelmingly positive feedback from maintenance technicians and it plans to replicate the installation on a further six titrant drop valve blocks. The new valve technology eliminated leaks from the critical process line which has increased operational efficiency. Furthermore it eliminated the need for unscheduled corrective maintenance and allowed maintenance to be completed within a dramatically shorter timeframe.
ITT Envizion Valve Benefits
• Mount and turn design allows quick disassembly.
• No tools required for installation and diaphragm replacement.
• Integrated thermal compensation system eliminates the effects of thermal cycling.
• Diaphragm changes reduced from an industry average of 23 minutes to 3 minutes resulting in a 90% reduction in maintenance time.