ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

  If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.

• Characterizing The E&L Profile Of Stoppers For Drug Stability

  The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

• Six Inhaler Sustainability Myths – And Why They Must Be Busted

  The solution to the carbon footprint of respiratory disease is complicated. The prevailing “myths” must be examined and addressed to achieve the shared industry vision of a decarbonized inhaler market.

• Designing Delivery Devices For Older Adults With Cognitive Impairment

  Leverage our insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment.

• Masking Bitter Drug Taste In Pediatric Formulations With Microcaps

  The challenge was developing a taste masked, convenient dosage formulation of a very bitter API for patients two-years old and older undergoing treatment of HIV infection.

• PFAS In Medical Devices: Expert Insights On Frequently Asked Questions

  Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.

• FAQs On The Revised EU GMP Annex 1: Volume 2

  Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Establishing And Safeguarding Shelf Life In Combination Products

  Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

• Building Sustainability Into Medical Devices

  Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.