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Extractables And Leachables Characterization Of Drug Products Packaging Manufacturing And Delivery Systems Medical Devices Dennis Jenke

Name: Extractables And Leachables Characterization Of Drug Products Packaging Manufacturing And Delivery Systems Medical Devices Dennis Jenke
SKU: BELL-44448614
Price: 31.00 USD
Availability: InStock
Rating: 4.7 (16 reviews)

SKU: BELL-44448614

Extractables And Leachables Characterization Of Drug Products Packaging Manufacturing And Delivery Systems Medical Devices Dennis Jenke

$ 31.00 ~~$ 45.00~~ (-31%)

4.7

16 reviews

Extractables And Leachables Characterization Of Drug Products Packaging Manufacturing And Delivery Systems Medical Devices Dennis Jenke instant download after payment.

Publisher: John Wiley & Sons

File Extension: PDF

File size: 10.57 MB

Pages: 457

Author: Dennis Jenke

ISBN: 9781119605072, 1119605075

Language: English

Year: 2022

Product desciption

Extractables And Leachables Characterization Of Drug Products Packaging Manufacturing And Delivery Systems Medical Devices Dennis Jenke by Dennis Jenke 9781119605072, 1119605075 instant download after payment.

EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices
Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards.
Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices.