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Full-service support: Cleanroom qualification and calibration

Full-service support: Cleanroom qualification and calibration

Losan Pharma GmbH.

Reference

Full-service support: Cleanroom qualification and calibration

at Losan Pharma GmbH, Neuenburg

Losan Pharma GmbH develops and produces solid, oral drugs for notable pharmaceutical manufacturers. In addition to the production of various solids, the products are assembled and packaged, e.g. in stick packs, blister packs or tubs. In Neuenburg, Losan Pharma operates cleanrooms of classes C and D and ISO classes 7, 8 and 9.

In 2006, Testo Industrial Services performed the first qualification of cleanrooms and HVAC systems within the course of extension of production facilities at the Neuenburg site. Since then, the re-qualification of cleanrooms and the calibration of stationary systems, measuring systems and test equipment have been the focus of cooperation. In addition to end-to-end support, resources for events such as shutdowns, campaigns and new buildings are managed flexibly and according to expenditure.

Full-service-support

Our scope of services

at Losan Pharma GmbH, Neuenburg

  • Annual re-qualification of all cleanrooms in compliance with DIN EN ISO 14644-1
  • Determination of the particulate purity class
  • Filter leak test
  • Flow visualisation
  • Determination of the room air change
  • Recovery time measurement
  • Determining volume flow
  • Differential pressure measurement
  • Determination of the sound pressure level & illuminance
  • Performance of the cleanroom re-qualification in the course of extension of production facilities and conversions
  • Qualification of laminar flows (FFUs)
  • Plan development (OQ, PQ) in Testo’s own qualification format, adapted individually to customer requirements
Clean room qualification by Testo Industrial Services
  • Calibration of stationary production facilities, e.g. vacuum granulators, fluid bed coaters, tray dryers, spheronizers, agitators & container mixers, muffle furnaces, stick pack systems, extruders, blister lines, blister testers, and sachet machines
  • Measured parameters calibrated on site: Temperature, pressure and differential pressure, volume flow, and time measurement
  • Annual calibration of the monitoring system (GLT) and the testo Saveris® system used in the temperature-controlled cabinets and storage rooms for finished products
  • Daily discussion of the results and immediate feedback for test equipment outside the tolerance range
  • If necessary, performance of repairs and adjustments
On-site calibration by Testo Industrial Services
  • Thermodynamic measured parameters (data loggers, measuring instruments for surfaces, infrared, humidity and temperature)
  • Mechanical measured parameters (pressure sensors and force measuring instruments)
  • Dimensional measured parameters (calliper gauges, thickness measuring instruments, gauge blocks)
  • Volume flow and flow rate (vane and volume flow hood)
  • Electrical measured parameters (multimeters) and optical measured quantities (rpm)

 

Laboratory calibration at Testo Industrial Services

Full-Service-Support

The result

at Losan Pharma GmbH, Neuenburg

“The production of our innovative dosage forms in the various compositions and our large fleet of machinery require a broad range of expertise in quality assurance. Testo Industrial Services not only provides the necessary metrological and regulatory expertise, but also practised customer orientation; this means we have been able to rely on this support in the area of qualification and calibration for more than 10 years. Thanks to the permanent use of Testo Industrial Services experts at Losan in Neuenburg, we have been able to enjoy utmost reliability in terms of observing compliance requirements, with little coordination effort and transparent processes.”

Magdalena Zakowski, Head of Equipment Management at Losan Pharma

Meeting situation Testo Industrial Services

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

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