Wednesday, 22 May 2019
9:00
Welcome & Introduction
9:30
Theory 1: Introduction Into Regulatory Requirements of Visual Inspection
- USP 1, USP 788 and 1788, USP 790 and 1790
- PhEur e.g. 2.9.20 • JP e.g. 6.06
- Annex 1
- Similarities and differences in compendial methods
- 100% inspection and AQL testing
- Definitions and practical examples of inherent, intrinsic and extrinsic particles
10:45
Coffee Break
11:15
Theory 2: Introduction Into Technical Principles of Automated Inspection Machines
- Functionality of automated inspection machines
- Camera systems / light / motion
- Image processing and database system
- Interlinkage of parameters: Speed, Rotation speed, Inspection parameters, Detection probability, False reject rate
- Properties, capabilities and limitations of automated inspection systems
- Scope of Automated Visual Inspection
12:15
Lunch Break
13:15
Theory 2: Introduction Into Technical Principles of Automated Inspection Machines (cont.)
14:15
Theory 3: Considerations on Primary Containers and Product Properties
- Vials, Ampoules, Syringes, Blow – Fill - Seal, Viscous liquids, Air bubbles / scratches, Refrigerated product containers
14:45
Exercise 1: Developing an URS Considering the Triangle Cost / Quality / Time
15:45
Coffee Break
16:15
Theory 4: Selection and Purchasing of an Automated Inspection System
- Technical requirements
- Integration into existing processes, lines/ machines and systems
- Cost and effort considerations
- Risk Assessment
17:15
Exercise 1 (cont.): Presentation of the Results of the Sub-Groups and Discussion of the Results
Q & A
17:30
End of Day 1
Thursday, 23 May 2019
9:00
Recap of Day 1
9:15
Theory 5: Transition from Manual Inspection to Automated Inspection
- Manual inspection as a prerequisite for transition to automated inspection
- Interpretation of inspection results and validation data
- Considerations on validation program for automated inspection
- Performance measurement
- Maintaining the manual inspection
10:15
Exercise 2: Principle Basic Image Processing Using an Open Source Library
11:00
Coffee Break
11:15
Exercise 2 (cont.): Presentation of the Results
12:00
Theory 6: Qualification Test Set and Routine Test Set
- Statistical considerations on number of objects containing defects
- Particle selection, particle size and size uniformity
- Labelling of test set objects
- Supply/purchase of test sets
- Maintaining and lifecycle of test sets
- Sampling from rejects
- Defect master library
- Types of defects
- Quality requirements
13:00
Lunch Break
14:00
Theory 7: Visual Inspection Lifecycle and Control Strategy
- Integration of visual inspection into overall manufacturing process
- Elements of lifecycle
- Particle identification/characterization
- Defect libraries as dynamic database
- AQL and control charting
15:00
Theory 8: Operation and Maintenance of Automated Inspection Systems
15:30
Coffee Break
16:00
Future Trend of Automated Visual Inspection
16:30
End of Training Course