Bio-Pharmaceutical Validation Services

Fluid Components provides the biopharmaceutical market with Validation Services, particularly focused in the areas of sterilizing filter validation and polymeric product contact extractables testing and validation.

A typical Sterilizing Filter Validation includes the following, all in accordance with the PDA Tech Report #26 guidelines;

• Viability testing
• Bacterial challenge testing
• Product specific integrity value determination
• Chemical compatibility testing

Detailed Extractables Testing services on filter products or any polymeric material (i.e. tubing, bio bags, etc) coming in contact with your pharmaceutical product. This is a qualitative and quantitative analysis of detectable compounds, down to ppm/ppb levels. Testing protocols are developed using ‘worst case’ extraction, followed by wide range of analytical techniques including; FT-IR, GC/MS, RPHPLC, UV-VIS, GPC, HPCE, SFC, NVR, and TOC.

Sartocheck IQ/OQ and Calibration services. On-site execution of IQ and OQ protocols and testing of Sartocheck integrity tester instruments as well as routine calibration.