Visual Inspection and Particulate Control (single user digital version)

Table of Contents:

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Prologue

1. Background
2. Detection
3. Isolation, Characterization and Identification
4. Remediation and Prevention
5. Life-Cycle Approach
6. Case Histories — Examples of Product Failure
7. Epilogue

Appendix A
Steromicroscopical Isolation Station Elements — What's needed?

Appendix B
Level 1-2-3 Flow Chart

Appendix C
Particle Descriptors

Appendix D
Microchemical Tests

Appendix E
An Example of an Internal
Microscopy-Based Database

Appendix F
Method for Destructive Testing
Of Difficult-To-Inspect Products

About the Authors

D. Scott Aldrich, has deep experience in contamination analyses for a broad array of pharmaceutical products with a rich history in many aspects of pharmaceutical product development. He is a recognized expert in pharmaceutical particulate matter control using solid-state analytical approaches. His passion is the application of microscopic methods for the identification of particulate matter. With over 40 years' experience in his pharmaceutical and consulting career, Scott has investigated particulate matter problems affecting parenteral liquids, suspensions and lyophilized products, ophthalmic liquids and suspensions, capsules, compressed tablets, coatings and polymeric delivery systems. Scott is an experienced teacher and lecturer in microanalytical applications, primarily optical microscopy, electron microscopy, infrared spectroscopy, and knowledgeable in optical crystallography, particle size, physical character determination, X-ray diffraction, and thermal analysis.

Scott received his BS in Microbiology from Western Michigan University and trained with McCrone Research Institute, Chicago IL. With pharmaceutical positions in Upjohn, Pharmacia, Pharmacia & Upjohn and Pfizer, he directed analytical labs supporting both quality control and R&D organizations tracking the source of contamination and product instability, supporting R&D product formulation development and evaluating new package presentations. As the principal consultant for Ultramikro, LLC he provides particulate matter control investigation and microanalytical training for personnel in the pharmaceutical, instrument and food industries in the Americas and Europe. Scott has published and presented his work in the field of visual inspection, microanalysis and spectroscopic analyses. He has served on USP expert committees for the last 10 years, and is currently a member of the USP Dosage Forms expert committee. Scott has designed and presented particle determination teaching modules for USP Pharmacopeial Education, and is an active member of PDA, AAPS, ACS and microscopical societies.

Roy T. Cherris has over 39 years of Quality Assurance experience. He is a founding member and Managing Partner of Bridge Associates International consultancy focused on pharmaceutical manufacturing excellence. He is also President and founder of InQuest Science which troubleshoots product defect issues and provides training and guidance on particulate matter control, optimized inspection and defect tracking systems. Roy formerly served as the head of Microbiology Laboratories for Hoechst Marion Roussel and Aventis Pharmaceuticals with a focus on the microbiological aspects of parenteral, liquid and solid dose manufacturing. Roy is a well-respected expert in the field of visual inspection systems and investigative microscopy for particle source identification and mitigation. He also specializes in the physical characterization of excipients, bulk drug substances and primary packaging components as it applies to pharmaceutical development, clinical and commercial manufacturing. His technical expertise includes visual Inspection, investigative microscopy, aseptic manufacturing, sterilization processes, environmental monitoring, microbiological testing, medical devices, laboratory and process development, as well as the qualification of equipment, facilities, and instrumentation. He has extensive experience with the validation of software, computerized control systems and metrology systems. Roy has worked internationally throughout the Americas, Europe and Asia.

Roy received his B.Sc. degree in Life Sciences with concentration in Microbiology at Trenton State College with further studies at Pacific Western University. Roy also studied forensic microscopy extensively at the McCrone Research Institute in Chicago. He also served as a member of the PDA task force on Visual Inspection and is the chair of the PDA task force for evaluating particulate matter in Difficult to Inspect Parenterals. Roy is on the USP Expert Panel for Visual Inspection of parenterals. He has been key in drafting guidance which lead to the establishment of USP <790> Particulate Matter in Parenterals and General Guidance ChapterUSP<1790> for best practices in particulate matter inspection programs. Roy's professional activities have included various technical committees in ASQ, ASTM, ISPE, PhRMA, PDA, American Society for Microbiology, Institute of Environmental Sciences, the New Jersey Pharmaceutical Quality Control Association, and the United States Pharmacopeia.

John G. Shabushnig, Ph.D. is the founder and Principal Consultant of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience including Sr. Manager/Team Leader in Pfizer's Global Quality Operations where he was responsible for providing visual inspection, microbiology and aseptic manufacturing technical support to manufacturing sites worldwide. He began his career in the pharmaceutical industry as a Research Scientist with The Upjohn Company responsible for development projects in the areas of Process Analytical Technology (PAT) and visual inspection. With the formation of Pharmacia and Upjohn, he became the Director of Technical Support and Engineering with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering, automation and documentation. He was subsequently promoted to the position of Business Unit Director of the Center for Advanced Sterile Technology (CAST), Pharmacia's sterile isolator production facility.

John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association (PDA), having served on the Board of Directors (2003-2011) and as Chair (2008-2009) and is currently serving as Chair of the Science Advisory Board (SAB) and the founder and leader of the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute (TRI). John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He is also a member of the American Chemical Society (ACS). He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and visual inspection of pharmaceutical products.