Sterilization, storage and quality-control solutions aligned with EU GMP, FDA 21 CFR Part 11 and USP. In-house manufacturing in Abrera under ISO 13485 with documented IQ/OQ/PQ qualifications.
The pharmaceutical industry demands laboratory equipment that proves metrological traceability, process repeatability and documentary compliance. JP Selecta manufactures autoclaves, ovens, refrigerated cabinets and centrifuges that meet the EU GMP guidelines, the FDA 21 CFR Part 11 requirements on electronic records and the USP general methods on temperature uniformity and exposure time.
Our Autester, Presoclave and Conterm ranges include data loggers, auditable alarms and validatable software. Every unit ships with a calibration certificate traceable to national standards and full IQ/OQ/PQ qualification documentation ready for review by your quality assurance officer or external auditor.
Requirements for moist and dry heat sterilization — autoclaves and depyrogenation ovens.
Electronic records integrity: digital signatures, audit trail, access control in equipment software.
General methods on temperature uniformity, heat distribution and validated sterilization cycles.
Sterilization of healthcare products — validation and routine control of steam processes.
Quality management system for medical devices — JP Selecta certified at its Abrera plant.
Current good manufacturing practice for finished pharmaceuticals.
Saturated steam sterilization with fractional vacuum and F0 load validation, Autester and Presoclave lines.
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Dry heat depyrogenation at 250 °C, Drytime and Hightemp ovens with DIN 12880 uniformity.
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Storage of thermolabile products at 2-8 °C and -20 °C with alarms and temperature traceability.
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Separation of plasma, serum and cell suspensions in tabletop or floor format with interchangeable rotors.
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Pilot-scale synthesis and formulation with PID control of temperature, agitation and dosing.
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Quality control of syrups, suspensions and emulsions in compliance with USP <911>.
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In-house manufacturing plant in Abrera certified ISO 9001:2015, ISO 14001:2015 and ISO 13485:2018.
Own technical service with guaranteed spare-part availability throughout the equipment lifecycle.
76 years of track record (founded 1947) supplying European pharmaceutical laboratories.
IQ/OQ/PQ documentation delivered with every unit and validatable software per 21 CFR Part 11.
Our technical team supports you in selection, qualification and maintenance of the equipment. Request a no-obligation quote and receive the matching regulatory documentation.