Industry: Medical Equipment and Pharmaceutical
Top 5 multinational medical devices, pharmaceutical and consumer packaged goods manufacturer
A top 5 multinational medical devices, pharmaceutical and consumer packaged goods manufacturer has established a global labeling center of excellence supporting its 8+ franchises including the Surgery, Cardiovascular, Orthopedics business groups. The client partnered with Atos to establish a support model for labeling artwork management.
Atos also worked with the client to improve packaging services. ASTM methods for medical device packaging with strict adherence to zero defect policy. Tyvek lids, used to seal blister packs, must be in perfect condition to avoid leakages. The company’s existing Pac-Vac detector failed to identify holes smaller than 250 microns. The new vision system can detect holes in the Tyvek as small as 100 microns.
- Multiple franchises with different labeling processes/ SOPs
- Multiple, standalone and disintegrated labeling and PLM systems
- Complex organization structure
- Heavy inflow of artwork requests from different sources
- Coordination with label printing, translation vendors
- Identify most susceptible leakage areas.
- Translucent opacity and veins-like pattern in the Tyvek makes micro hole detection complex – 50% chance of human error.
- Defining a new method that can be easily adapted over different Tyvek Opacities.
A managed service model performed: change analysis, impact assessment, artwork design/development, QC/ proof-reading, vendor coordination. Artwork processes were standardized with tools such as enLabel, Adaptive, ETQ, Kallik, Adobe Illustrator and InDesign.
Vision systems use high-performance DSLR cameras to accumulate 24-million pixels in a concentrated area, picking up micro holes. Opacity is controlled by under/overexposing the Tyvek to backend lighting. True/false edges were distinguished by scouting through the threshold of edges.
- Scalable, robust artwork delivery management
- Process harmonization
- Quality and regulatory compliance
- Automated processes (such as quality control and proof-reading) improved productivity and quality
- 60% cost savings
- 5% year-over-year productivity increase
- >95% accuracy
- >100% accuracy micro hole detection in Tyvek lids.
- Deformation of 100 microns and above is detected within 5 secs.
- The portable system can be installed on production lines for defect inspection or in labs for random sample-testing.
Making an effective transition to EU MDR and IVDR
The medical device manufacturing industry is undergoing a series of unprecedented regulatory changes due to evolving EU regulations.