Experience

The PGC Validation staff has performed euqipment/system validation and performance qualifications for the following:

Laboratory System Validation Services

Laboratory System Validation

  • Laboratory equipment validation including ovens, coolers, freezers, glass washers, and environmental controls 
  • Chromatography data collection systems (CMS) and instrumentation validation 
  • Mass spec validation 
  • UV-Vis validation 
  • HPLC validation 
  • GC validation 
  • Analytical method validation services 

Equipment Validation

Equipment Validation

  • Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, dispensing controls, and automated sequences 
  • Solid dosage bottle, solid dosage blister, ointment, cream, liquid and sterile packaging lines includin optical inspection stations and check weighers
  • Solid doasage packaging lines including bar code verification systems, bottle unscramblers, heat sealers inspection machines, lablers, pouch dispenser, and shrink bundlers 
  • Pharmaceutical blenders, horizontal and vertical mixers, granulars, milling machines, dryers, drying rooms metal detectors, emulsifiers, polishing pans, fluid bed processers, weighing systems, tablet coating systems, tablet presses, and encapsulators 

Facilities and Utilities Qualification

Facilities and Utilities Qualification

  • Environmental control systems including HVAC systems, Building Management Systems (BMS), Clean Rooms, and Temperature / Humidity / Differential Pressure Control Systems
  • Plant utilities systems including water-for-injection (WFI), deionized water, steam system, and compressed air systems 
humidity chambers

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