Visible particulate matter has long been a popular topic for PDA members. In fact, the PDA Paper, “Industry Perspective on the Medical
Risk of Visible Particles in Injectable Drug Products,” has been viewed over 9000 times on the PDA Journal of Pharmaceutical Science and
Technology website (1). Ideally, both industry and regulators seek a clearly defined, risk-based particle specification (e.g., size, type and
quantity). While such specificity is desirable, the lack of relevant clinical trials limits the ability to establish specifications typically done
for other “impurities.” Therefore, sterile manufacturers have relied on a large body of anecdotal information to guide understanding of
clinical risk. While this is useful, it does not offer an exact limit for setting acceptance criteria for injectable products and the primary
packaging used in their preparation. This, coupled with the normal variability of human visual inspection, has led to a wide range of
practices and limits applied to particles in injectable drug products and their packaging materials. Due to PDA members’ involvement in
providing consensus-based guidance to the industry, the Pharmaceutical Manufacturing Forum (PMF) has tasked PDA members with
diving deeper into developing particle specifications.
A new task force has formed to align on a common, harmonized rationale across the industry and develop a practical guide intended for
use along with existing compendial, regulatory and industry standards. The Zero Defects for Visible Particles in Injectables Task Force
plans to identify gaps in current risk assessments and methods used to detect and quantify visible particles in order to develop a series of
best practice documents. The purpose of these documents would be to potentially reduce defects related to particles. Within this group,
subgroups will work on separate workstreams, each working to identify a visible particle size threshold, analytical method gap analysis
(for elastomer and glass components) and validation strategies. Volunteers working within these subgroups will consist of representatives
from both manufacturers and suppliers to ensure a well-balanced perspective for resulting documents.
PDA intends to expand the resources relating to visible particulates to support continuous improvement and development of new best
practices for the industry and its members. In fact, the 2017 PDA Visual Inspection Forum in October will offer opportunities to learn
more about the latest practices in this area and discuss some of the task force’s developments.
- Bukofzer, S. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products.” PDA Journal of Pharmaceutical Science and Technology 69