The Aseptic Core
01 November 2016

The Aseptic Core

“The Aseptic Core” discusses scientific and regulatory aspects of aseptic processing with an emphasis on aseptic formulation and filling. This column has been developed to provide practical advice to professionals involved in the qualification of aseptic processes and the myriad support processes involved.

  • Construction and qualification of a new aseptic processing area is a complex project involving multiple disciplines
  • Good upfront strategic planning is critical for an effective qualification effort. All involved disciplines should be involved in planning for an aseptic facility.
  • Construction and qualification of a new aseptic processing facility can be divided into several phases: planning, design, construction, commissioning, qualification, submission, and project closeout.
  • Detailed design reviews should be performed on vendor design documents. These reviews should be repeated for any design changes.
  • The US Food and Drug Administration’s aseptic processing guideline, the European Commission’s GMP Annex 1, and International Organization for Standardization (ISO) 14644-4 can serve as useful references during design reviews
  • Cleanrooms are generally designed using a pressure cascade that maintains a minimum differential pressure of 10–15 Pascal positive to adjacent areas of lower classification
  • Cleanrooms and aseptic complexes should be designed for optimum flow of material, equipment, personnel, and waste streams so that raw materials and waste streams cannot cross over finished goods, personnel cannot move from less clean to cleaner areas without gowning, clean and dirty equipment cannot mix, and multiple products are segregated
  • Cleanroom classification is performed per the ISO 14644 series of standards some cleanroom reclassification activities can be satisfied with routine monitoring data.
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