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Validation of Aseptic Pharmaceutical Processes
Revised and expanded from the 1986 original. Provides a detailed, single-source reference for designing, qualifying, calibrating, certifying, and validating systems required to prepare aseptic and non-aseptic pharmaceutical products. Compiles compliance and regulatory principles, documentation practices, scientific approaches, and engineering concepts that can be used independently or in combination to validate products, processes, and equipment. Among the topics are facility design, monitoring non-viable particles, validating utilities, steam sterilization-in-place technology, sterilizing-grade filters, preparing components, packaging operations, and process control and quality systems.
Co-editor with Frederick Carleton, Validation of Pharmaceutical Processes: Sterile Products,
29 Chapter text on the validation of systems utilized in the production of sterile products.
2nd edition published by Marcel-Dekker in 1999.
ASIN: 0824773624
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Reviews
"…an excellent presentation on the subject of validation of pharmaceutical processes related to sterile products. It is written in a simple language and can be easily understood at the same time without losing the importance of the subject. The book will be an asset to education institutions in pharmacy and pharmaceutical technology, project and manufacturing personnel of sterile product manufacturing organisations and also to quality assurance and R&D personnel."—Pharmatimes
James Agalloco has published a variety of other publications. If you'd like a copy of any of these papers, please send Jim an email.