November 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...
See BlogMay 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...
See BlogAugust 19, 2019
Prior to this past spring the latest version of the ISO 10993 Part 18 was more than 13 years old and was more of a descriptive standard highlighting what kind of techniques and approaches one could possibly take. There was...
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