Until recently, medical gas testing was routinely assigned to industrial testing labs (non-GMP) that tend to serve a variety of industries. In June 2003, the FDA issued a new Guidance Document on medical gas usage. Since then the pharmaceutical industry has begun the process of qualifying gases they routinely use in production operations.
To meet these emerging needs, Whitehouse Laboratories has invested in the technology and personnel required to offer comprehensive gas testing services for pharmaceutical and biotechnology clients.
Commonly tested gases includes:
- USP / EP Nitrogen
- USP / EP Oxygen
- USP / EP Carbon Dioxide
- USP / EP Helium
- USP / EP Medical Air
Proper sampling of gases is critical since most test failures result from sampling errors. Whitehouse Labs offers on-site sampling at the client location.
If on-site sampling is not required, Whitehouse Laboratories will assist clients with sample cylinder rental and shipping. The Labs also offer an extensive inventory of stainless steel sample cylinders that undergo a routine and extensive cleaning process.
Whitehouse Laboratories quality assurance team will work with clients to develop gas testing protocols and validation reports to insure your company meets FDA requirements for medical/process gas usage.