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- Title
Aseptic-containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies.
- Authors
Drinkwater, James L.; Kranenburg, Holger
- Abstract
Patient safety is paramount, so, when sterile toxic and biologically active products are manufactured, the expectation in aseptic processing is that the barrier containment systems are operated at positive pressure and containment attributes are applied to the barrier or by application of other containment solutions, including closed systems. The balance between aseptic processing for patient safety and operator safety in processing hazardous products requires an aseptic containment strategy (ACS) that would need to fit alongside a contamination control strategy (CCS) as defined in the EU Guidelines to Good Manufacturing Practice (Annex 1 revision). This article defines the considerations for preparing an ACS.
- Subjects
BIOLOGICAL products; MICROBIAL contamination; PHARMACEUTICAL industry; ASEPTIC packaging; CLOSED system transfer devices
- Publication
European Journal of Parenteral & Pharmaceutical Sciences, 2019, Vol 24, Issue 1, p12
- ISSN
1740-6277
- Publication type
Article