Main Presentation: Qualification of Primary Container Closures

Presentation 1 (15 Min)

Breaking the Bacterial Barrier: Enhanced Targeted Therapy on the Lipopolysaccharide of Pseudomonas aeruginosa Using a Phage-Antibiotic Cocktail

Presented by

Ms. Driti Rajkumar

Microbiology & Immunology Research Intern

Department of Microbiology and Immunology,

University of California, Irvine

Abstract: Antibiotic resistance has become a global crisis, demanding innovative solutions beyond traditional drugs. Phage therapy—using viruses that target specific bacteria—offers a promising alternative due to its precision, biofilm-degrading ability, and low toxicity. This study focused on Pseudomonas aeruginosa, a multidrug-resistant pathogen responsible for hospital and cystic fibrosis infections. We investigated the synergy between bacteriophage OCP-2 (isolated from North Ohio sewage) and aminoglycosides Gentamicin and Tobramycin. The phage-antibiotic combinations significantly inhibited bacterial growth in vitro. Sequence analysis of OCP-2 revealed tail proteins resembling depolymerases, supporting its capacity to break down polysaccharides. Both treatments targeted lipopolysaccharides to enhance bacterial eradication. Future work aims to re-engineer phages with multiple mechanisms of action to boost therapeutic potential. These results underscore phage-antibiotic synergy as a powerful strategy to combat antibiotic-resistant P. aeruginosa.

Presentation 2 (45 Min)

Qualification of Primary Container Closures

Presented By

Aryo Nikopour

Vice President

Global Pharma Market Segment

Nelson Labs (A Sotera Health Company)

Abstract: Ensuring the integrity and performance of primary container closure systems (CCS) is a critical element of pharmaceutical product quality, safety, and regulatory compliance. As global regulatory expectations evolve — including requirements from the FDA, EMA, USP <1207>, ISO 8871 series, and EP 3.2 guidelines — manufacturers are under increasing pressure to implement robust qualification programs that address both functional performance and chemical safety.

This presentation highlights the scientific and regulatory framework for qualification of primary container closures, emphasizing the following key areas:

· Extractables & Leachables (E&L) Studies

· Container Closure Integrity Testing (CCIT)

· Functional & Mechanical Qualification

· Regulatory Expectations & Industry Trends

By combining scientific rigor with a risk-based, patient-centric approach, the presentation outlines best practices for developing a comprehensive qualification strategy that supports global submissions, mitigates compliance risk, and ensures that primary container closure systems perform reliably throughout a product’s lifecycle.

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