New Steps in Automated Inspection Performances and Validation A case study. Association. Brevetti CEA Inspection machines

Transcription

1 PDA: New Steps in A Global Automated Inspection Performances and Validation A case study Association Brevetti CEA Inspection machines

2 First considerations... Why automated inspection is not as common as the manual or semiautomatic ones? Long process to get validation status Impact of process variation on validation What are the most critical phases of a project? 2

3 Regulatory Primary Responsibility Regulated Company User Requirements Specification Requirements Testing Specification Functional Specification Design Specification Functional Testing Integration Testing Verification Module (Unit) Specification Module (Unit) Testing Code Modules Supplier Supplier Knowledge and Technical Expertise Supplier QMS

4 Current Scenario Samples Setup + Test on Inspection Machine $$ VALIDATION Inspection Requirements $ Time Changing conditions: Different Components Minor Process Fluctuations New Defect Types $$$ New Products PRODUCTION INTERRUPTION 4

5 Improvement Targets 1 Fast adaptation to process & components variation 2 Minimize future validations time and production stops 3 Grant consistent validated status along time 4 Accurate estimation of reject rate before production 5 Setup of new products in parallel to production 5

6 Product Digital Library

7 Implementation steps Samples Selection Creation of a Digital Library Parameter Setting Continuous improvement PRODUCTION 7

8 Customer experience: overview Automatic Inspection Machine Rondo trayer Denester No-glass-to-glass-contact Pre-Filled Syringe (PFS), 1ml syringe Ø 8.15mm, transparent watery liquid

9 Customer experience: case study PFS (Pre-filled Syringes), 1ml syringe Ø 8.15mm, transparent watery liquid Automatic Inspection machine pcs/h Dedicated Hardware for high framerate real-time acquisition Workstation for Offline elaboration

10 Customer experience: case study Reject Samples Good Samples Digital Library Recipe 10

11 Glass defects examples

12 Particles defects examples

13 New defect glass deformation Glass deformation (found later, initial detection rate 62%) Digital Library

14 New defect : particles Particle on stopper (found later, initial detection rate 68%) Digital Library

15 Final Results Inspection (unit) Efficiency Efficiency False Reject After new defect implementation Efficiency Efficiency False Reject Particles 3 stations 97.6% (RZE) (RZE) 0.61% (B VS A) 107.2% (B VS A) 0.64% 97.8% (RZE) Glass Defects 2 stations (horizontal + inclined) 99.6% (RZE) 108.7% (B VS A) 0.32% 99.78% 0.35%

16 Feedback of the experience -Product Digital Library covering the entire product lifecycle -Simplification: - samples manipulation reduced consistently, - prevention of samples ageing, - reduced cold-storage procedures, - prevention of samples loss and damage - Setup time: drastically reduced Mechanical assembly Optical setup Parameter setting Performance testing -30% -30% -75% Time gain 16

17 Option available on models A1 MARIO A50 A35 K32S K15 Ampoules Vials VialsSyringes - Cartdriges Ampoules Pre-Filled Vials - Cartdriges Ampoules Cartdriges Pre-Filled Syringes pcs/hour pcs/hour 600 pcs/hour 17

18 Main Features Continuous motion of the turret Indipendent brushless motor for spindles rotation At least 24 High Resolution images for each inspection station (instead of 8 images of standard inspection machines) Perfect alignment between camera, container and lighting

19 Vision System Advantages Aligned Oscillating Principle Alignment camera + illuminator MISALIGNED Static Principle Illuminators have a non homogenous background. Alignment System Pros: More efficient Sensitivity increased Less False Reject Image subtraction sequence Bank of differences Image subtraction sequence Bank of differences

20 final question Is it time for guided parametrization or even automatic parametrization?

21 Thanks to PDA Organization You all for your interest!!! Brevetti CEA S.p.a.