• Bulk Manufacturing
  • Atmospheric Gases (e.g., Oxygen, USP; Nitrogen, NF)
  • Carbon Dioxide, USP
  • Nitrous Oxide, USP
  • Helium, USP
• Container Manufacturing (High pressure, liquid containers)
• Container Labeling (handling, precautionary wording)
• Container filling
  • Liquid to Liquid (transports, vehicle mounted vessels, large cryogenic containers, cryogenic home vessels - patient use vessels)
  • Liquid to Gas (filling cylinders using a storage tank, pump, and vaporizer system)
  • Gas to Gas (filling cylinders via pressure cascade, or compressor aided transfer)
  • Mixtures (partial pressure blends, gravimetric blends, dynamic blends, pre-mixes)
  • Calibration Standards
  • Compressors used for filling air
• Product Distribution
• Hospital/Healthcare Facility Installation

To assure that manufacturing equipment and processes consistently produce gas products that meet expected specifications, the firm using the equipment and process should validate the equipment and/or process. Gas Regs, Inc., can assist your firm identify the critical process parameters, develop a validation protocol, and conduct the validation study.

To verify specifications are met, in-process materials and/or final products are typically tested in accordance with a sampling and testing plan for conformance to established identity, strength, quality, and purity characteristics. To assure the tests are scientifically sound, regulations require test methods to be validated (except official USP/NF test methods that are followed precisely). In addition, all methods used (including USP/NF methods), must be shown to be acceptable under actual conditions of use. Gas Regs, Inc. can assist a firm develop a test method validation protocol and conduct the validation studies.

Gas Regs, Inc., can also offer expert testimony as to current manufacturing and handling practice within the medical and food gases industry.