News | April 17, 2017
Orthopedic Design and Technology Magazine featured Pacific BioLabs in their recent March/April issue. The article discussed new medical device technologies and the testing challenges incurred with these more advanced devices. PBL explains the cleaning, […]
News | July 17, 2016
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 A draft guidance on the same subject […]
News | May 17, 2015
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 […]
News | May 17, 2015
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 […]