Particulate Matter, E&L Topics of Interest to Journal Readers

Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of February.

1. Review. Stephen E. Langille, “Particulate Matter in Injectable Drug Products” May/June 2013
2. PDA Paper. Stan Bukofzer, et al. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products” January/February 2015
3. Research – PQRI Special Section. Dennis Jenke, et al. “Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products” September/October 2013
4. Review – PQRI Special Section. Diane Paskiet, et al. “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)” September/October 2013
5. Review. Edward C. Tidswell and Tim Sandle, “Microbiological Test Data— Assuring Data Integrity” January/February 2018
6. Review. Fran L. Degrazio, “Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity” January/February 2018
7. Case Studies. Ana M. C. Santos, et al. “A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016” January/ February 2018
8. Research. Galen H. Shi, et al. “Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System” January/ February 2018
9. Research. Dennis Jenke, et al. “Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products” March/April 2017
10. Research. Jeffrey R. Vieregg, “Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials” January/February 2018