Equipment 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
- HPLC, UPLC, GC, LC-MS
- 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.
STERILIZATION
- 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
PACKAGING
- 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