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Raising the Bar on Quality

Seeking Subvisible Particles

Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.

While there are no standardized definitions for particulate sizing, subvisible particles are generally considered to be particulate in the range of 1 to 25 µm. In its recent Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter,” the FDA offered a non-binding recommendation for an insoluble particulate matter test for injections. The test is harmonized with the European and United States pharmacopeias. The insoluble particulate matter test for injections or infusions is designed to test for subvisible particulate and includes two possible procedures: Light obscuration Particle Count Test and the Microscopic Particle count Test. The FDA notes that it may be necessary to conduct both tests to ensure that the injectable product conforms to requirements.

For customers concerned about subvisible particles, West offers NovaPure® components, which West developed using a comprehensive quality target product profile (QTPP) that included a subvisible particle specification as part of the component critical quality attributes (CQAs).

Features and processes that help ensure reliability include:

  • FluroTec® barrier film – a proven, effective barrier against extractables that also provides lubricity without the need for silicone oil
  • Validated wash and sterilization processes that help ensure consistency of stopper preparation
  • 100 percent vision verification to assure extremely low levels of visual defects
  • Lot-to-lot extractable profile to assure material consistency

For more information about NovaPure, click here.

NovaPure® and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. FluroTec technology is licensed from Daikyo Seiko, Ltd.