July 12, 2021
The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be...
See BlogNovember 20, 2020
Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective. Lyophilized drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution...
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May 26, 2020
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy. When that balance is disturbed by issues such as product adulteration, the damage to patients, revenues and corporate...
See BlogDecember 11, 2019
In Chemical Characterization studies for Medical devices, as well as in Extractables & Leachable Studies for Pharmaceutical Packaging Systems, it is of the utmost importance that one can correctly identify the compounds encountered by your screening methods. The reason for...
See BlogNovember 5, 2019
During their Extractable & Leachable Qualification work, many Pharma and Biopharma companies qualifying their Small Volume Parenteral Container Closure systems (vial, syringe, or cartridge) may have come across certain compounds that they now recognize as rubber oligomers. While the...
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