Mr Mats Serler, the Manager of Maintenance & Engineering, explains what his department is doing, and describes their most important work
”Our job is to maintain all production depended systems in a shape to produce quality products without any disturbance” Mr Serler explains. ”To achieve that we have an overall maintenance system covering all machinery, utility systems and buildings as well as a calibration system for all critical instruments and meters.”
Why are these systems so important?
“First of all, to be able to run a production site for pharmaceuticals we have to follow guidelines and requirements from the authorities in different countries such as MPA, EMEA and FDA. They stipulate rules for what must be in place to follow GMP, Good Manufacturing Practice. That means we must maintain and calibrate all our production critical equipment within certain intervals.”
What intervals are typical?
“For calibration of instruments we have a typical period of one year between calibrations, but for example, a balance must be verified before each use. For maintenance of equipment or buildings there can be other periods but the most important is that it is performed and documented.“
What about utility systems such as water, ventilation and process gases?
“The same principle is in place for these systems, but here we have even more requirements, such as quality tests of the manufactured products. As an example we test the produced Purified Water every day when we use it in the production of pharmaceuticals."
You mentioned buildings earlier, is there requirements also for buildings?
“Buildings and premises are very important to keep in a good status, especially production, packaging and laboratory buildings, because this have influence of the ability to keep the premises clean and tidy, and last but not least, the overall impression of our plant."
What else does Maintenance & Engineering work with?
“New production projects, installations and rebuilding as well as daily routines to keep all systems under control.”