Product category:
R&D, Test and Evaluation Services
News Release from: CPR Automation | Subject: FDA test rigs
Edited by the Processingtalk Editorial
Team on 09 May 2005
Test rigs conforming to FDA standards
A specific request from one customer asked for a machine to flush and test medical filters using pure water or IPA, giving CPR a challenge, particularly making the design conform to FDA guidelines
Assembly of medical filters using infra red welding or transmission laser welding is one of the world wide strengths of CPR Automation Then one customer asked for a machine to flush and test medical filters using pure water or IPA, and a new set of challenges arose
This article was originally published on Processingtalk on 15 Nov 2006 at 8.00am (UK)
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The project fell into distinct areas, software, fabrication and pipework.
The software was the easy part, as all of the CPR machines have state of the art control systems usually with data collection.
The fabrication and pipework were different matters.
CPR have produced steel fabrications for machines and machine tools, but not in stainless steel and certainly not stainless pipework up to 2" diameter.
The design of the system required considerable thought to ensure that it conformed to all of the medical industry requirements.
In terms of material selection it was decided to go for 316 stainless throughout, and the design of the joints and weld had to ensure no traps or inclusions.
In addition a great deal of design time was spent analysing the system to ensure that there were no dead legs for water or IPA to lie in.
Indeed the requirement for an air leak test meant that the system had to be capable of a total flush to allow the leak test to be carried out.
A clever design meant that the same pipework which introduced the water for flushing was vented after flushing and switched to air for leak testing.
The optimum size of pipe was required to be small enough for accurate leak test but large enough to give sufficient flow to fill the system for flushing.
The project was a huge success and CPR have now built a number of such machines of varying capacity and test parameters, however the basic requirements remain:- keep the pipework runs to a minimum, avoid ledges and have good quality inclusion free welds.
The investment in this project has further improved the CPR ability to provide equipment which meets medical/pharmaceutical requirements and conforms to FDA standards.
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