Compliance and Validation Services

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Equipment and Facilities Validation

PharmaSys can assist your company with equipment qualifications, provide a turn-key solution for initial validation in preparation for pre-approval inspections, and provide re-qualification as well as remediation services. As required by the client, PharmaSys also offers project management.

Capabilities

The PharmaSys staff has performed equipment/system validation and performance qualifications for the following:

  • Environmental control systems including HVAC systems, Building Management Systems (BMS) such as Metasys, clean rooms and temperature/humidity/differential pressure control systems.
  • Plant utility systems including water-for-injection (WFI),deionized water (DI), steam systems, compressed air systems, alcohol systems, and nitrogen systems.
  • Temperature mapping of ovens/dryers (walk-in and laboratory), drying rooms, autoclaves, coolers, refrigerators, freezers, cool storage rooms, cold storage rooms, incubators, environmental chambers/stability rooms (temperature and relative humidity mapping) utilizing Kaye Validator®, Digistrip®, and Kaye ValProbe® systems.
  • Sterile/Biotech equipment/systems including lyophilizers, sterile/bioreactors, filter systems, filter integrity test systems, pressure/temperature controls, packaging systems and environmental controls.
  • Laboratory systems including ovens (furnaces, muffle ovens, and vacuum ovens), coolers, refrigerators, freezers, environmental controls, glass washers, laboratory information systems (LIMS), chromatography data collection systems and instrumentation. Other instruments validated include: UV-Vis spectrometers, FT-IR spectrometers, high performance liquid chromatography (HPLCs), gas chromatographs (GCs), and capillary electrophoresis systems (CEs).
  • Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls, and automated sequences.
  • Solid dosage bottle, solid dosage blister, ointment, cream, liquid and sterile packaging lines including optical inspection stations and check weighers.
  • Solid dosage packaging lines including bar code verification systems, bottle unscramblers, heat sealers, inspection machines, labelers, pouch dispenser, and shrink bundlers.
  • Pharmaceutical blenders, horizontal and vertical mixers, granulators, milling machines, dryers (walk in tray dryers), drying rooms, metal detectors, emulsifiers, polishing pans, steam kettles, pumps, hand held mixers, fluid bed processors, weighing systems, tablet coating systems, tablet presses, and encapsulators.
  • Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).


If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.


 
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