Reference Standard Test Sets
DiS reference samples for visual inspection qualification
Defect test sets from Q Labs, part of QPS Engineering AG, are custom reference kits for the qualification and validation of visual inspection: manual (MVI), semi-automated (SAVI) and fully automated (AVI). Every set is built from DiS samples, Defect Imitation Samples, that reproduce real production defects in a stable and repeatable form. They provide standardised conditions and reference samples, so operator detection rates and machine performance can be measured against the same benchmark over time and across sites. Used consistently, test sets demonstrate GMP compliance during audits, expose weak points in inspection equipment and processes, and bring down the false reject rate, which cuts rework and protects yield. Sets are produced on the basis of the Q Labs defect catalogues for vials and syringes, and are kept fit for use over their life through cleaning, re-qualification, a reserve sample pool and service.
Technical specifications
- Set types
- Fuko, DiS, ST
- Inspection methods
- MVI, SAVI, AVI
- Containers
- Vials, syringes
- Samples
- DiS defect imitation
- Configuration
- Customer specific
- Compliance
- GMP
- Maintenance
- Service contract
- Made in
- Stein, Switzerland
Defect catalogue
Gross overfill, vial
Cracks in vial sidewall, neck, heel or base
Missing stopper
Visible particles in the vial or on the lyo cake
Defective seal or exposed stopper
Gross overfill, syringe
Cracks in syringe barrel or finger grip
Missing needle shield
Visible particles between plunger and stopper lamellae
Visible fibre in the product or on the plunger
Key features
- Fuko test set verifies the functionality and operational capability of equipment and systems
- DiS probabilistic test set measures detection rates for non-deterministic particles and defects
- DiS static test set analyses fixed defects on containers and packaging materials
- ST system test set verifies the accuracy of cameras and optical components
- Standardised conditions and reference samples for comparable results
- Operator qualification and detection rate measurement
- Equipment qualification and validation for MVI, SAVI and AVI
- Identifies weak points in inspection equipment and processes
- Reduces the false reject rate and the cost of rework
- Demonstrates GMP compliance during audits
- Built on the Q Labs defect catalogues for vials and syringes
- Maintenance programme: cleaning, re-qualification, reserve sample pool and service
Test sets are produced to customer specification on the basis of the Q Labs defect catalogues for vials and syringes. Scope, defect types and sample counts are defined per project.
