Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.
Moderator
Hélène Pora, Ph.D.
Vice President, Single Use Technology
Pall Corporation
Speakers
James Hathcock, Ph.D.
Senior Director, Regulatory and Validation ConsultingTeam
Pall Biotech
Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
White paper: A risk based approach to validation studies for sterilizing filtration.
Biotech | Pall Corporation webinar series
¡Todo sobre los ensayos de validaciones para cumplir con los máximos estándares regulatorios!
Hablaremos sobre puntos cruciales de los servicios de validación, incluyendo:
1. Necesidad de validación
2. Cómo se realizan los ensayos de validación
3. Análisis de riesgo: re uso de filtros y toma de decisión en ensayos a realizar
4. Servicio de Validación Pall: documentación requerida para iniciar una cotización
¡No pierdas esta segunda oportunidad!