Session: Development & Validation of a Controlled Extractables & Leachables Testing Program Supporting Inhalation, Transdermal, & Injectable Drug Delivery


Monday, August 20, 2007

8:30 AM-11:00 AM BCEC -- Room 102B
Development & Validation of a Controlled Extractables & Leachables Testing Program Supporting Inhalation, Transdermal, & Injectable Drug Delivery

Sponsor: Chemic Laboratories, Inc., Booth 113. Instructor: Joseph St. Laurent. 8:30-11:00 AM. This exhibitor workshop will feature case studies describing how to design a controlled extraction study. The workshop will encompass evaluation of extractable analyses from inhalation, transdermal, and injection delivery devices manufactured by various companies. Leachable validation schemes and accelerated ageing and stability study designs will be also discussed. Such product testing is required by worldwide regulatory agencies to document the safety, quality and reproducibility of components used in delivery of finished drug products.