Whitehouse Labs -- the only FDA-regulated, GMP-laboratory that offers complete gas testing services following USP test procedures.

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 Labs has invested in the technology and personnel required to offer comprehensive gas testing services for pharmaceutical and biotechnology clients. Commonly tested gases include:

• USP / EP Nitrogen
• USP / EP Carbon Dioxide
  
• USP / EP Oxygen
• USP / EP Helium
  

Whitehouse Labs Helps Clients Improve  Product Quality, Stability and Process Integrity with the recent introduction of a validated Nitrogen Test Procedure equivalent to the compendial of the NF Monograph Gas Chromatograph requirements.  The new test offers detection limits of 100 ppm of oxygen versus the current USP specification of 10,000 ppm.  This means clients can now verify much lower levels of oxygen than the current NF method provides. 

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 Labs 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 Labs' quality assurance team will work with clients to develop gas testing protocols and validation reports to insure your company meets FDA requirements for medical gase usage.   

 Toll Free 877-823-9300