The critical role of CCIT in nuclear medicine and radiopharmaceuticals

The critical role of CCIT in nuclear medicine and radiopharmaceuticals The critical role of CCIT in nuclear medicine and radiopharmaceuticals

Container Closure Integrity Testing (CCIT) plays a crucial role in nuclear medicine and the production of radiopharmaceuticals, where precision and safety are key. Due to their radioactive nature, these products require exceptional handling to protect healthcare professionals, patients, and ensure the effectiveness of the medication. Any breach in container integrity can compromise the sterility of the drug, making it ineffective or even harmful.

 

Sepha’s CCIT Solution for Nuclear Medicine Projects

Sepha recently collaborated with a leading biotech company to address their CCIT challenges for a new radiopharmaceutical oncology drug. To meet stringent FDA requirements, the company required a highly sensitive, non-destructive CCIT method to guarantee product integrity and safety.

Sepha delivered a tailored solution using multiple Multi-Q machines with pressure decay test methods, enabling the biotech company to:

  • Meet FDA regulations with confidence
  • Protect the integrity of high-value drug vials
  • Provide a safe environment for personnel
  • Improve operational efficiency and reduce costs


The Result:
  Sepha helped the company to navigate complex regulatory requirements, ensure the safety of their team, and optimise their production for a successful market launch.

Interested to learn more?  Read the full customer story ‘Overcoming CCIT Complexities in Radiopharmaceuticals‘.

 

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