100% Inspection of BFS Ampoules
In the world of pharmaceutical packaging, maintaining the integrity and safety of sterile products is paramount. The European Union's GMP guidance (Annex 1) mandates a 100% Container Closure Integrity Testing (CCIT) for all fusion sealed sterile pharmaceutical containers (below 100ml), including blow-fill-seal (BFS) ampoules and bottles. Similarly, USP <1207> offers detailed guidelines for the packaging of sterile drug products. Our state-of-the-art integrity testing solutions are designed to fully comply with these stringent regulations, ensuring the utmost quality and safety of BFS containers.
The challenge of automated BFS inspection
Pharmaceutical manufacturers face the dual challenge of adhering to rigorous safety standards while maximizing production efficiency. Traditional methods for testing the integrity of BFS containers often fall short in terms of speed and reliability, leading to potential compromises in product safety and increased operational costs.
Our approach for BFS CCI testing
To address these challenges, our approach integrates the latest generation of vacuum decay testing procedures with a comprehensive visual inspection system. Our CCIT method, the LFC method®, is not only sensitive and robust but also capable of handling a wide variety of BFS container sizes and shapes, including those with very small volumes, sensitive and non-conductive liquids.
Our solution of 100% BFS inspection
Our automated CCIT systems (R DPPA) utilize the innovative LFC method® for high-speed, 100% integrity testing of BFS containers. The entire BFS container is tested, a significant advantage over methods such as High-Voltage Leak Detection (HVLD), where only certain areas are tested and partial measurements are possible.
In addition, our integrated visual inspection system utilizes modular camera stations to inspect each ampoule for under-filling, fill level and cosmetic defects. This automated solution is designed to seamlessly fit into existing production lines, enhancing both the speed and accuracy of the inspection process.
Benefits of our 100% CCI inspection of BFS ampoules
- High Sensitivity: Detects defects of 10µm and below, ensuring a superior level of quality control.
- Increased Efficiency: Capable of inspecting up to 60,000 containers per hour; easy and tool-less format changeover.
- Enhanced Compliance: Fully meets EU GMP and USP <1207> requirements.
- Cost Reduction: Reduces the need for manual inspections, significantly cutting down operational costs.
- Comprehensive Data Management: Ensures data integrity and compliance with 21 CFR Part 11, crucial for regulatory audits.
- Versatility: Suitable for various shapes, sizes, and types of contents within BFS containers, including those with low fill volumes and non-conductive liquids.