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Related Experiment Videos

Achieving "Zero" Defects for Visible Particles in Injectables.

Jennifer Johns1, Paolo Golfetto2, Tia Bush3

  • 1Pfizer, Inc, N. Peapack, NJ, USA.

PDA Journal of Pharmaceutical Science and Technology
|September 21, 2018
PubMed
Summary

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This summary is machine-generated.

Controlling visible particles in parenteral products is crucial for quality. The Parenteral Drug Association (PDA) and Pharmaceutical Manufacturers Forum (PMF) are developing new methods to assess primary packaging cleanliness and analyze the supply chain for particle contamination.

Area of Science:

  • Pharmaceutical Manufacturing
  • Quality Control
  • Drug Delivery Systems

Background:

  • Visible particle control is essential for high-quality parenteral products.
  • Primary packaging materials are a significant source of particles in injectable products.
  • Current methods for assessing packaging cleanliness require improvement.

Purpose of the Study:

  • To develop and validate improved test methods for assessing the cleanliness of primary packaging components.
  • To conduct an end-to-end supply chain analysis to identify particle entry points.
  • To establish risk-based acceptance limits for particles in injectable products.

Main Methods:

  • Formation of a joint task force by the Parenteral Drug Association (PDA) and Pharmaceutical Manufacturers Forum (PMF).
Keywords:
Injectable productsPrimary packaging componentsProcess improvementRisk assessmentVisible particles

Related Experiment Videos

  • Development of new test methods for evaluating particle contamination from primary packaging.
  • Comprehensive analysis of the entire supply chain, from shipment to fill and finishing operations.

    • Main Results:

    • Progress in developing standardized test methods for primary packaging cleanliness.
    • Identification of critical control points within the supply chain where particles may be introduced.
    • Establishment of a framework for aligning control limits between suppliers and manufacturers.

    Conclusions:

    • Improved particle control strategies are necessary for consistent parenteral product quality.
    • Enhanced collaboration and standardized methods will lead to better control of visible particles.
    • The initiative aims to ensure injectable products meet compendial and GMP standards.