EEquipment Validation

All automatic, mechanical, and electronic equipment used in production, quality control testing, packaging, and storage of cGMP product must be validated. 21 CFR section 211.68 states the following:

Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is used, it shall routinely be calibrated, inspected, or checked according to a written program designed to assure proper performance.

Our expert equipment validation team specializes in following types of equipment.

Analytical Lab Equipment

  • Spectrophotometers (UV/VIS, IR, FTIR)
  • Plate Readers, Micro Readers, Flow Cytometer, Protein Sequencer
  • Incubators, Autoclaves, Refrigerators, Freezers, Ovens
  • MB Laminar Flow, Biosafety Cabinets,
  • Degassers, TOC Analyzers, Lyophilizers
  • Titrators, Dissolution, Stability Chambers

Software and DAS Systems

  • Chemstore, Chemstation, Empower, MassHunter, Millenium, OpenLAB
  • SoftMax Pro, Delta V, DSC, SCADA

Manufacturing Equipment

  • Mixers, Dryers, Fluid Bed Dryers, Tablet Presses, Sterilization Tunnels, Tanks
  • Syrup, Capsule, Ampoule and Vial Fillers
  • Coating, Blistering, Cartooning, & Labelling Equipment
  • Ointment and Cream Filling
  • Bioreactors, Centrifuges, Columns, Filters etc.


  • Steam Sterilizer (Aseptic and Terminal), Dry Heat Sterilizers, Isolator Sterilization
  • Hydrogen Peroxide, Gamma Irradiation C60
  • Product and Commodity Sterilization systems
  • Clean in Place (CIP), Steam or Sterilize in Place (SIP)

Vision and Labeling Systems

  • Labelers
  • Automated Vision Systems
  • Labeling and Inspection for HIBC and Barcodes
  • Laser and Engraved Printing


  • Inventory Recognition Systems (RFID)
  • Heat Tunnels and Blister Pack
  • Cartoners, Trayers, Checkweigher Machines, Inkjets, Case Formers and Tapers
  • Sealers, UDI Labelers

Test Equipment

  • Friability testers, Dissolution Samplers
  • Refractometers
  • Powder Handling Equipment
  • Freeze Dryers