PDA TR 76

PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers consistent and standardized quality criteria that can be used by pharmaceutical and medical device manufacturers for the visual inspection of incoming elastomeric components and aluminum seals, and by suppliers for outgoing inspection. This report is not intended to establish mandatory standards for the classification and identification of elastomeric component and aluminum seal nonconformities. It is intended to be a single-source overview that complements existing guidelines and standards or documents listed in the reference section of this technical report.