Innovative leak testing solutions in hospital pharmacies
Amidst heightened regulatory demands from the revised Annex 1, which increased the focus on leak testing of ampoules, many hospital pharmacies and GMP preparation units found themselves unequipped with the necessary machinery to conduct 100% Container Closure Integrity Testing (CCIT). Facing this challenge, eyetec's Visual Inspection Consultant, Robin, developed an innovative method leveraging the existing capabilities of hospital pharmacies. Utilizing vacuum pulses from an autoclave followed by 100% manual Visual Inspection, Robin validated a method to detect potentially leaking ampoules effectively. This unique approach, based on a thorough risk analysis and statistically substantiated leak test samples, received acceptance from GMP inspectors.
This method is not only cost-effective but also bypasses the need for expensive and complex leak testing machines, making it a viable option for hospital GMP units that produce medications for in-hospital use and clinical trials.
Enhancing Vvisual Inspection processes in animal health
A global leader in animal health improved production efficiency by transitioning from manual to semi-automatic and automated Visual Inspection systems. This shift was driven by increased production volumes and the need to inspect opaque or colored products previously unchecked. eyetec’s Visual Inspection consultant, Robin, played a key role in developing a strategy to classify these products as 'difficult to inspect'. He will establish robust Visual Inspection protocols and spearhead strategic engineering runs to refine the inspection parameters, achieving high accuracy and reducing false rejects.
Implementing advanced Visual Inspection in pharmaceutical production
eyetec assisted a top-tier pharmaceutical company in setting up an automated Visual Inspection system for injectables. Starting from the factory acceptance test (FAT) through to site acceptance tests (SAT) and full operational qualifications, Robin ensured flawless integration and functionality. This Visual Inspection system underwent rigorous performance qualification, optimizing the detection parameters to ensure high precision in identifying and rejecting defects. Through meticulous testing and validation, this Visual Inspection process was confirmed to meet or exceed the effectiveness of manual inspections, emphasizing eyetec's commitment to advancing product quality and safety in pharmaceutical manufacturing.
- Robin, Visual Inspection Expert at eyetec
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