PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)

Visual inspection of filled injectable products is an important part of the control strategy of the manufacturing process. It offers a means to improve quality by removing noncompliant units and provides information to drive continuous process improvement.

This technical report addresses test and inspection methods for visible particles in primary packaging components for injectable products, specifically glass vials and syringes, and the elastomeric closures used to seal them. This document is most relevant for ready-to-sterilize (RTS) and ready-to-use (RTU) components since these are not subjected to a further cleaning process immediately before use.

These studies and methods were developed as part of a larger initiative to eliminate visible particles in injectable products. The test and inspection methods discussed within this report are the first step in a standard-setting process. Once test and inspection methods are available, accepted, and implemented, they can be used to assess process capability and establish meaningful process control limits. Without reliable measurements, reliable control limits are not possible.

An overview of this initiative was published previously, and a detailed analysis of particle entry points to the manufacturing process was subsequently published, as follows:

• * Achieving "Zero" Defects for Visible Particles in Injectables
• * Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations

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Format: PDF (1 file 2.22 MB)

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