Journal Preview

This edition of the PDA Journal of Pharmaceutical Science and Technology offers three papers on pharma microbiologys: Tidswell & Sandle on Micro Data Integrity; Menezes, et al, on QRM and micro contamination for non-sterile drug products; and Jimenez, et al, on real-time PCR for low-level contamination.

Review

• Edward C. Tidswell, Tim Sandle, “Microbiological Test Data – Assuring Data Integrity“
• Fran L. DeGrazio, “Holistic considerations in optimizing a sterile product package to ensure container closure integrity“

Research

• Matthew V. Tirrell, et al., “Inhibiting sterilization-induced oxidation of large molecule therapeutics packaged in plastic parenteral vials“
• Bruna Filipa Ribeiro Berardo, Ana Teresa Machado Reis, Rui Loureiro, “Quality of medicines in Portugal: a retrospective review of medicine recalls (2000–2015)“
• Natarajan Rajagopalan, et al., “Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System“

Case Study

• José C. Menezes, et al., “A QRM Discussion of Microbial Contamination of Non-Sterile Drug Products, using FDA’s and EMA’s Warning-Letters Recorded Between 2008 and 2016“

Technology/Application

• Luis Jimenez, et al., “Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination“

Commentary

• Derek Willison-Parry, et al., “Elastomer Change Out—Justification for Minimizing the Removal of Elastomers to Prevent Cross-Contamination in a Multiproduct Facility“
• Derek Willison-Parry, et al., “Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities“

Letter/Erratum

• John Mattila, et al., “Erratum to “Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration” “