Wednesday, 04 October 2023
Welcome & Introduction of Trainers and Participants
Introduction into test sets for manual visual inspection
- What is in principle a test set?
- Why do we need test sets?
- When should a test set be created?
- Overview of agenda of the training course
- naming the different types of test sets covered in the course
- main purpose
- timing when this type of test set will be covered during the course
- Distinction of test sets required for visual inspection from test sets required for CCI testing
Introduction into test sets for automated visual inspection
- How to handle test sets during a project?
- Test set for validation of automated visual inspection machine including AVI development test set
- Test set for daily performance check of automated visual inspection machine
- Knapp test set
10:15 Coffee Break
Purposes of test sets and background to the test set qualification process
- 100% VI and AQL
- QC testing (e.g. stability)
- Generation of supportive data for quality investigations/ Inspection support - justification of qualification process and control system
Design of test sets
- Introduction into a flowchart that has all the necessary steps to decide on the design of the test set (the flowchart should be one of the main course deliverables)
- Why do I need a risk assessment?
- How do I perform the risk assessment?
- What must the test set look like?
- Which primary packaging do I have in the facility?
- Which particle sources do I have in the facility?
- Which product defects do I regularly see in the facility?
- Which defects must be included in my test sets?
- Relevance to quality investigations: criteria for assessment of the criticality of quality events
- Frequency of occurrence
- Typical vs Atypical
- Relevance to QC testing
- Introduction into US FDA classification
- Generic vs. product-specific test sets
Particles and defects
- Overview of types of particles
- Spherical particles (balls)
- Irregular glass fragments
- Adhering particles
- Overview of other defects
- Container defects (Cracks, Scratches, Leaking)
- Stopper defects
- Cap defects or crimping defects
- Contaminations (inside outside)
- Solution defects
- How many containers must be included in the test set?
- “defect-free” containers
- “defective” containers
- What must my associated defect library look like?
- Types of defects
- Sizes of defects
- Major defect
- Minor defects
- Critical defects
- Which classes of defects must be included in the test set?
12:30 Lunch Break
Tour to the Körber Vision Laboratory
Vision evaluation of a test set, step by step
- Check test set for completeness
- Visibility of defects
- Mechanical set up for test set evaluation
- How do particles behave
- Definition of camera stations and illumination for AVI
- Creation of vision configuration for AVI, based on test set
- Definition of detection rate & false eject rate of AVI
15:00 Coffee Break
Special test sets - what do they need to look like?
- Lyophilized products
- Difficult to inspect products
- Colored glass containers
- Turbid liquids
- Substitute solutions versus real product
Technical considerations on test sets for difficult-to-inspect products
- Small volume and large volume containers
- Lyo containers
- Infusion bags
- Solutions with turbidity
- Colored solutions
- Colored containers
- Solutions with high viscosity
Challenges of difficult to inspect products for automated visual inspection
- Products prone to air bubbles
- Foaming products
- Highly viscous products
- Toxic products
- Lyophilized products
- Emulsions / Suspensions / Turbid liquids
Wrap up training course day 1
End of Training Course Day 1