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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.
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 the 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
As a non-member of PDA, you can purchase this Technical Report for $325. Or, you can join PDA by 19 May for $279 and download your personal digital copy for FREE! And, when you become a PDA member, you will gain on-demand access to the entire online library of more than 80 peer-reviewed Technical Reports – valued at more than $10,000. Join PDA for less than the non-member price of this Technical Report and gain access to all Technical Reports and technical documents and a wealth of other members-only benefits. Be sure to join by 19 May to gain FREE access to Technical Report No. 85 (TR 85): Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers.
