Articles


Automated CCI-QC for PFS

The shift to Automation is so that every regulatory and guidance body is driving towards more reliable and accurate test methods. Automated deterministic inspection processes for complete quality control of prefilled syringes has become a greater part of pharmaceutical manufacturing. An ideal process has no compromise and there are no trade-offs in achieving objectives. PTI’s robotic automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technology provides the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality. Either of PTI’s parenteral CCI solutions (HVLDmc or Vacuum Decay) can effectively be deployed for the wide range of parenteral package formats and application requirements in a robotic automated platform. Between the two technologies, 95% of parenteral applications can be tested for CCI down to critical to quality leak sizes. Both technologies are validated as non-destructive methods with leak detection sensitivity down to critical parenteral leak sizes.

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