With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have expanded as well. Medications for regulating blood glucose levels are […]

Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a range […]

Poster presented on the Chemical Characterization of Leachables/Extractables from Medical Devices PBL Analytical department recently presented a poster on the Chemical Characterization of Leachables/Extractables from Medical Devices at the Extractables and […]

Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the drug's safety and effectiveness." 1 While in vivo drug interaction studies […]

On March 1, 2016 the International Organization for Standardization published the new edition of the ISO 13485 standard. Previously updated in 2003, the revision places more emphasis on the quality […]

A recent article from the Parenteral Drug Association (PDA) Journal provides some of the best information we have found on methods to determine and characterize extractables. It is definitely suggested […]

In March of 2015, the FDA published a new guidance document titled, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.  A draft guidance on the same subject […]

According to a recent Markets and Markets report, the global bioburden testing market is expected to reach $565.6 Million by 2018, and Pacific BioLabs has been listed as one of […]

Now available is the recorded copy of the webinar PBL and Nutek presented in April, "Why Understanding Bioburden and Sterilization is Key to Successful Device Development. You can listen and […]

Pacific BioLabs and Nutek used to work closely together to perform the microbiology and sterilization needed for medical device sterilization validation programs.  Nutek was bought out by BART and the […]