Blister Inspection

How Blister Inspection Systems Prevent Pharmaceutical Product Recalls?

Discover how advanced blister inspection systems, like the Sunshine SuperVision BISv15, are crucial in preventing pharmaceutical product recalls by ensuring quality, detecting defects, and enhancing continuous process improvement.

The integrity of pharmaceutical products is central to public health. Even a single defective blister—such as an empty cavity, broken tablet, or contamination—can trigger costly product recalls. These recalls not only damage patient trust but also harm brand reputation.

This is where advanced blister inspection systems play a pivotal role. By ensuring rigorous quality control at the packaging stage, manufacturers can prevent risks before products ever leave the production floor.

What Do Blister Inspection Systems Do?

Blister inspection systems use high-resolution vision technology to examine every tablet and capsule during blister packaging. Whether working with Alu-Alu or Alu-PVC materials, these systems inspect each cavity against strict quality criteria.

They detect defects in real time, such as:

Missing or empty pockets
Broken or chipped tablets and capsules
Incorrect shapes, colors, or dimensions
Foreign particles inside cavities
Mixup Prevention with Pharmacodes printed on foil (via secondary camera)

By automatically rejecting defective packs, manufacturers ensure only flawless blisters continue downstream.

Introducing the Sunshine SuperVision Blister Inspection System BISv15

The Sunshine SuperVision Blister Inspection System BISv15 has been engineered with more than 15 years of expertise in pharmaceutical packaging. It integrates seamlessly with equipment from leading global manufacturers like Uhlmann, Marchesini, and CAM.

Key highlights include:

Inspection speeds exceeding 50 strokes per minute
Detection of multiple defect types simultaneously
Intelligent Rejection Mechanism with options for “ALL Reject” or “SELECTIVE Reject”
Compatibility with both Alu-Alu and Alu-PVC formats

This flexibility allows pharma companies to minimize waste without compromising product quality.

How BISv15 Helps Prevent Pharmaceutical Recalls

The BISv15 directly safeguards patient safety and reduces the likelihood of recalls by offering:

Early Defect Detection – Faulty blisters are rejected immediately on the line.
Operational Integrity – Independent rejection control avoids interference with blister machine PLCs.
Regulatory Compliance – Optional FDA 21 CFR Part 11 features ensure secure data, audit trails, and digital signatures.
GMP Assurance – Designed to meet stringent Good Manufacturing Practice requirements.
Detailed Batch Reporting – Batch Completion with documented evidence (PDF).

Beyond Recalls: Broader Manufacturing Benefits

The true value of blister inspection extends beyond compliance:

Waste Reduction – Selective rejection prevents unnecessary product loss.
Efficiency Gains – Automated inspection reduces reliance on manual checks.
Cost Savings – By avoiding recalls, downtime, and rework, manufacturers achieve significant financial savings.

Enhancing Production with Robotics

The BISv15 can also be integrated with robotic pickers, such as Delta Robot by Sunshine Corporation, to automate blister transfer to cartoners. This reduces conveyor footprint while boosting overall efficiency and consistency.

Measuring Success with OEE

For manufacturers focused on performance, the BISv15 offers an optional OEE (Overall Equipment Effectiveness) module. It captures insights such as:

Power consumption
Downtime
Headcount allocation
Material usage

This enables accurate cost analysis and continuous process improvement.

Conclusion

Pharmaceutical recalls are more than financial setbacks—they are risks to patient safety and brand trust. By adopting advanced blister inspection technology like the Sunshine SuperVision Blister Inspection System BISv15, manufacturers can take proactive steps to safeguard quality, protect patients, and strengthen their reputation.

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