Validation of Equipment
 

We specialize in the qualification of equipment and systems as well as in the validation of manufacturing, packaging, cleaning and sterilization processes. Our experienced team of specialists will assist you in meeting the qualification and validation regulatory requirements.

 

 We offer our clients

 
 
 
Validation Master
Plan Writing
Risk Analysis Studies
to equipment/system
qualifications and GMP Requirements
Equipment and System
qualification
Process Validation
 

 We qualify the following equipment and systems

 
  • HVAC and building management systems (BAS)
    as well as clean rooms and controlled environments
  • Utility systems:
    water-for-injection (WFI), purified water, clean/pure steam, compressed air systems, nitrogen systems, etc.
  • Temperature-controlled equipment:
    autoclaves (steam sterilizers), lyophilizors, dry heat ovens, refrigerators, freezers, incubators, environmental chambers/stability rooms, etc.
  • Laboratory equipment:
    ovens (furnaces, muffle ovens, and vacuum ovens), water baths, shakers, evaporator, pH meters, glassware washers, etc.
  • Solid dosage products manufacturing equipment:
    blenders, mills, granulators, dryers, fluid bed dryers, tablet presses, tablet coaters and encapsulators
  • Semi-solid products manufacturing equipment:
    mixing kettles, homogenizers, and mixers
  • Packaging equipment:
    bar code verification systems, bottle unscramblers, heat sealers, inspection machines, labelers, pouch dispensers, shrink bundlers, filling machines (tablets and liquids), cappers and case packers.
 

 Process Validations

Oral solid dosage, semi-solids (ointments, creams and suspensions) as well as liquids manufacturing
Packaging validation studies
Cleaning validation studies