Maintenance and calibration

TOF mass spectrometers are very robust and usable with a wide variety of ion sources and inlet systems. Having only simple electrostatic and no magnetic fields, their construction, maintenance, and calibration are usually straightforward. There is no upper theoretical mass limitation all ions can be made to proceed from source to detector. In practice, there is a mass limitation in that it becomes increasingly difficult to discriminate between times of arrival at the detector as the m/z value becomes large. This effect, coupled with the spread in arrival times for any one m/z value, means that discrimination between unit masses becomes difficult at about m/z 3000. At m/z 50,000, overlap of 50 mass units is more typical i.e., mass accuracy is no better than about 50-100 mass... 

Variety of instrumentation leads to complex maintenance and calibration procedure, e.g., different types, different manufacturer, and ages of instrumentation leading to problems in maintenance. 

Check HVAC maintenance records against equipment lists. Collect existing maintenance and calibration records and check them against the construction documents (e.g., equipment lists and mechanical plans). Equipment that has been installed in inaccessible or out-of-the-way locations is frequently overlooked during routine maintenance. 

Samanta, P. K. and S. P. Mitra, Modeling of Multiple Sequential Failures During Testing, Maintenance, and Calibration, BNL, December 1981. 

Detectors will require frequent maintenance and calibration to perform accurately. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

Operational qualification involves performing a series of tests to check that all elements of the system are functional across the specified operating range. This usually involves performing challenges at the worst case extreme operating conditions. The process should allow confirmation of final operation, maintenance and calibration procedures. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

The purpose of the regulations was to ensure proper operation of laboratories that generated data to support either INDs or NDAs. In particular, they addressed animal studies, including animal care and animal accountability. They also involved the equipment used to do the various procedures for analysis and the maintenance and calibration of the equipment. In general, these regulations now cover the operation of the laboratories and how the data are collected and... 

Maintenance and calibration of equipment Standard operating procedures... 

Documented inspection, cleaning, maintenance and calibration of apparatus. Calibration to be traceable to national or international standards... 

Subpart D presents the regulations for the equipment used in a study. There are two subsections in both sets, the FDA and the EPA GLP one for equipment design and one for maintenance and calibration. The text of both sets are virtually identical, stating that all equipment must perform as required by the... 

Check the Code of Federal Regulations, Chapter 40, Part 160.81, and tell whether an SOP is required for maintenance and calibration of equipment. 

When appropriate means that a laboratory only need specify remedial action in response to equipment failure or malfunction when remedial action is appropriate to the piece of equipment. A laboratory may elect to discard rather than repair faulty equipment however, records for the discarded equipment, including records of previous maintenance and calibration, must be retained for the length of time described in 58.195(b) and (f). 

Operation, maintenance and calibration procedures Before commencing performance qualification, authorized procedures must be in place for routine use of the facility or operation, training of operators, routine calibration and maintenance, notification and recording of problems, and for the definition of actions to be taken in the event of breakdown. 

Ensure that maintenance and calibration routines are in operation... 

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