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Thermo Fisher Scientific

PSB-ICSP-1143-Rev A-Pressurized Eluent Bottles

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Thermo Fisher Scientific has reported incidents of pressurized eluent bottles bursting due to misuse and excess pressure. Only approved eluent bottles, pressure regulators, and pneumatic line sets should be used, as specified in the user manual. Direct pressurization from a gas source is prohibited. Replace bottles periodically to prevent aging and degradation.

Description: 

A.   Background

The IC/SP business unit has received a report of a pressurized eluent bottle bursting due to application of excess pressure being applied.  Investigation into the reports identified that the burst bottles were due to misuse and not following the user manual for that product.

A formal CAPA at Sunnyvale (CAPA-01890) was opened into the issue with the findings listed below.

B.   Symptoms

·         Burst/fracture of eluent bottles, spilling eluent fluid in the laboratory.

·         Eluent bottle parts expelled outwards, damaging property or persons.

Environment:

Eluent Bottles for Aquion, Integrion, ICS-6000 DP/SP, ASE 350, Inuvion, and Integral

Recommendations:

Proactive measures are required for any new installation of an Ion Chromatography instrument which has one or more pressurized eluent bottles.  Only approved Thermo Fisher Scientific eluent bottle P/Ns, with the maximum quantity per instrument, may only be pressurized using the approved pressure regulator and pneumatic line-sets P/Ns as given in the User Manual.  Direct pressurization of a bottle/bottles from a gas source is not permitted as it can pose an unacceptable risk to the user and/or nearby instruments if the bottle’s pressure rating is exceeded.

Current users employing eluent bottle pressurization must be reminded to use only approved Thermo Fisher Scientific bottles, pneumatic fittings/lines, and pressure regulators at no more than the maximum pressure given in the user manual.  Eluent bottles should also be replaced periodically (1-2 years) to ensure aging, or degradation does not occur which could increase the chance of the bottle bursting or leaking.  Direct bottle pressurization from a gas source is also not permitted, even if an external regulator is employed. 

The CAPA issued by the Quality team is still open and the IC/SP BU will continue to monitor. 

Thermo Fisher Scientific Subsidiaries and Distributors:  Please contact the IC/SP PSE Group (ICSP.ProductSupport@thermofisher.com) if the above recommendations do not resolve the issue.