2019 PDA Visual Inspection Forum

Increasing numbers of complex formulations and delivery system presentations that are difficult to inspect have entered the parenteral market. The concept of Difficult to Inspect Parenterals (DIP) describes product container/closure systems and or formations with limited capability for an effective 100% visual inspection. Robust product defect lifecycle management is the key to maintaining product quality with DIPs. The USP<1790> compendial chapter and PDA Technical Report 79 released in 2018 have clarified guidance on how to manage DIP products. This session will present discussions on control strategy approaches to address DIP inspection and supplemental destructive testing.

8:30 a.m. – 8:50 a.m.
Keys to Successful Qualification of Automated Inspection Equipment 
Ron Lawson, Senior Inspection Technology Specialist, Bristol-Myers Squibb

8:50 a.m. – 9:10 a.m.
Rise of the Machines: Can Automated Visual Inspection Reduce Human Error in Difficult to Inspect Products?
Amber H. Fradkin, PhD, Director, Particle Characterization Core Facility, KBI Biopharma, Inc.

9:10 a.m. – 9:30 a.m.
Transitioning from Semi-Automated to Automated Inspection: A Case Study for a Difficult to Inspect Product (DIP)
Aaron Shirkey, Senior Specialist, Engineering, Merck & Co., Inc. and
Ian T. Jehring,Specialist, Engineering, em>Merck & Co., Inc.

9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion

This session will provide some real-world problem solving when moving toward automated or multi-stage inspection processes.  Learn from those who have “been there before” to reduce false rejects in deployed automated systems, ensure that a new multi-stage inspection process is compliant and robust, and selecting the appropriate technology for your specific product.  These case-studies will also highlight contemporary methods for root cause analysis, evaluating inspection effectiveness, and targeted defect detection.

10:45 a.m. – 11:05 a.m.
Case Study: Controlling Interactions Between Packaging Components and Injectable Products that Can Lead to False Rejects
Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

11:05 a.m. – 11:25 a.m.
Compliant Approach to Implementation of Multi-Staged Inspection that Combines Automated and Manual Methods Techniques
Nicola Mauriello, GTO ExM Specialist, MSD International GmbH and
Andrea Cedrola, Equipment Validation Specialist, Patheon, part of Thermo Fisher Scientific

11:25 a.m. – 11:45 a.m.
Use of Automated and Manual Visual Inspection of Container Closure Integrity
Elizabeth Zybczynski, Director, Production and Process Control, Baxter Healthcare

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

Visual inspection systems are constantly evolving to take advantage of new concepts and technology. This session is designed to provide a quick survey of some of the unique technical capabilities in commercially available inspection systems. It should provide a useful benchmark for those considering upgrading existing hardware, assessing how best to meet a new inspection need or preparing for a future transition from manual or semi-automated inspection to automated inspection.

1:45 p.m. – 1:55 a.m.
Reliable Differentiation of Air Bubbles From Transparent Particles
Christain A. Scherer, Head of Sales, Seidenader Maschinenbau GmbH

1:55 p.m. – 2:05 p.m.
Particle Detection and Other Challenging Inspections Through a Phased in Machine Learning Approach
Steven Wardell, Director, Imaging, ATS Automation

2:05 p.m. – 2:15 p.m.
Deep Learning in Deep: From Research to Real Application
Massimo Frasson, General Manager, Brevetti C.E.A. Spa

2:15 p.m. – 2:25 p.m.
Automatic Visual Inspection of Lyophilized Products, Characterizes as Difficult to Inspect Products (DIP), with Very Low False Reject
Søren Christoph Meyer, Mechanical and HW Engineering Manager, InnoScan

2:25 p.m. – 2:35 p.m.
Particular Challenges in Automated Visual Inspection of Cartridges for Parenteral Drug Administration
José M. Zanardi Ocampo, PhD, Senior Manager, Bosch Packaging Technology K.K.

2:35 p.m. – 2:45 p.m.
Session Wrap-up

Nearing the conclusion of two days discussing the technical and scientific facets of particulate matter control, characterization, and identification this session will explore the question “What does all this mean clinically and what are clinicians saying?” The first speaker will discuss the challenges and risk management strategies involving the potential medical impact of particulates in difficult to inspect products. Next, a review of laboratory and clinical studies will be presented, looking at the potential mitigating impact of bedside in-line filtration in ICU settings. Third, an overview of the potential clinical implications of particles given current manufacturing and inspection capabilities will be presented. The Q&A provides a great opportunity to exploring the interface between capabilities and clinical impact.

3:30 p.m. – 3:50 p.m.
Inline Filtration IV Drugs
Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG

3:50 p.m. – 4:10 p.m. 
A Review of the Potential Clinical Implications of Particulate Matter in Injectables
R. Douglas Ross, MD, MBA, Senior Director, Pfizer Inc.

4:10 p.m. – 4:30 p.m.
Challenges and Risk Management Strategies for Medical Impact of Particulate Matter in Difficult to Inspect Parenterals 
Nathan Cox, Senior Manager, Quality Engineering, KYMANOX

4:30 p.m. – 5:00 p.m.
Questions and Answers/ Discussion

This is an opportunity to highlight, summarize and discuss the key points from both days of the Forum. Each of the session moderators will provide a brief summary of the highlights from their session during the conference.

5:15 p.m. – 5:45 p.m.
John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC
Roy T. Cherris, Managing Partner, Bridge Associates International & InQuest Science LLC
Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG
Robert J. Miller, Senior Manager Technical Services, Pfizer Inc.
Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines
Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

5:45 p.m.
Closing Remarks and Adjournment