Optimizing validation processes with eyetec’s CCIT Samples at Organon

These samples were needed to fine-tune recipes, conduct sensitivity studies, and prepare for audits. "eyetec’s CCIT samples have been very helpful for fine-tuning recipes and conducting sensitivity studies, which are critical to our validation processes," explained Bram Jansen, a project and validation engineer at Organon. 

The challenge 

The team needed CCIT samples that worked with different ampoule sizes and volumes and could handle high-voltage testing conditions. They also had tight deadlines and a limited budget, so planning and efficiency were very important. Along the way, they faced specific technical demands that needed to be addressed to ensure reliable results. 

The solution 

eyetec provided high-quality CCIT samples with detailed certifications that made it easier to meet regulatory standards and prepare for audits. "The detailed certification made regulatory compliance and audit preparation much easier. It allowed us to meet our requirements confidently and efficiently," Bram shared. 

When testing conditions needed adjustments, eyetec worked closely with the team to find tailored solutions. Their flexibility and quick support meant the project stayed on track, even when timelines were tight. 

Flexibility and collaboration 

eyetec’s support and flexibility were a big help throughout the project. “They delivered the samples on time and shared useful advice on how to optimize validation processes. Their flexibility and problem-solving approach have been a great help in keeping the project on track," Bram explained. The collaboration allowed Organon to manage challenges quickly and keep things moving. 

The results 

Working with eyetec delivered great results for Organon: 

• Validation made easy: The CCIT samples helped the team fine-tune recipes and run sensitivity studies with precision. 

• Reliable samples: eyetec worked with Organon to improve sample performance, ensuring consistent results. 

• Audit-ready documentation: The detailed certifications made preparing for audits much simpler. "Having these certifications simplified what could have been a much more complex audit preparation process," Bram said. 

• On-time support: eyetec’s quick responses and flexible support kept the project on schedule, even when last-minute needs came up. 

Conclusion 

The collaboration between Organon and eyetec demonstrates the importance of reliable partnerships in complex validation projects. eyetec’s ability to provide high-quality samples, adapt to specific needs, and offer strategic support for validation planning made a meaningful difference in achieving Organon’s goals efficiently." Jansen concluded.