The integration of CCIT
for radio­pharma­ceuti­cals

The automatic dispenser (OVDD/CVDD) and the Container Closure Integrity Tester (CCIT) are seamlessly integrated within the hot cell, optimizing your daily working progress and production speed.

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ANNEX 1 COMPLIANCE AND CCIT 

Radiopharmaceuticals must meet the strict requirements outlined in Annex 1 for sterility, inspection, validation, risk control, and quality assurance. Container Closure Integrity Testing (CCIT) is a crucial step in this process. In collaboration with Oxipack, Von Gahlen offers the advantages of automated in-line CCIT derived from regular GMP processes to the challenging environments of radiopharmaceuticals.

Fully integrated hot cell production lines 

With decades of expertise in radiation protection and GMP compliance, we design and build hot cells for both research and production. Our integrated solutions combine proven technology with innovation to meet the highest international standards.

Automatic filling system

Our OVDD and CVDD dose dividers precisely and quickly fill patient- specific vials. The software calculates optimal doses, scans vial labels, and generates customized identification to ensure safety and traceability. This makes the entire dispensing process smoother, more efficient, and optimized.

Container Closure Integrity Tester (CCIT)

Designed to handle a variety of rigid products, such as vials and bottles, the Container Closure Integrity Tester (CCIT) from Oxipack uses a vacuum decay method for effective, non-destructive leak testing. It delivers consistent, fast, and accurate leak detection, making it ideal for sensitive radiopharmaceutical products. The CCIT combines Oxipack’s pharmaceutical leak-testing experience with Von Gahlen’s hot-cell manufacturing and radiation-shielding expertise.

Leak testing for radiopharmaceuticals

For radiopharmaceuticals, leak testing involves checking whether a container or a vial is leaking unwanted radioactive material. Leak detection is to prevent the release of radioactive contamination during production, storage, handling, or transport.

From filling to transport

The integration of dispensing, inspection, and automated handling ensures that every vial is safely prepared, controlled, and securely packed in Type A certified packaging – ready for transport.
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Visual inspection system
The automatic dispenser (OVDD/CVDD) and the Container Closure Integrity Tester (CCIT) are seamlessly integrated within the hot cell, optimizing your daily working progress and production speed.

Features of the automatic filling systems:

  • Reliable system +10 years on the market
  • Designed according to GMP regulations
  • Well-developed hardware and updated user-friendly software
  • Pierced septum method (CVDD) / open vial filling  (OVDD)
  • Remotely operated, aseptic manipulation and dispensing
  • Safely and high-precision filling
  • Multi-dose or single-dose vials
  • Opening, filling, capping, and crimping of the pre-sterilized vial
  • Dispense up to 20 mL of the diluted radiopharmaceutical
  • Sterile disposable set – easy transition between batches
Sterility and aseptic production
Radiopharmaceuticals must be manufactured in strictly controlled sterile environments.

The optimal workflow for sterile filling and closure inspection with integrated systems

Open Vial Dose Divider (OVDD) & Closed Vial Dose Divider (CVDD)

Open Vial Dose Divider (OVDD) & Closed Vial Dose Divider (CVDD)  

Features of the CCIT:

  • Fully automated leak detection
  • Accurate operator-independent results
  • In compliance with Annex 1
  • Remotely operated
  • Compact design for hot-cell integration
  • Non-destructive vacuum decay method (ASTM F2338)
  • 21 CFR Part 11 compliant software for secure electronic records and signatures
  • Suitable for diverse vials
  • Easy change parts in case of multiple shaped products.
  • Integrated vacuum pump and control systems
  • Ideal for sensitive radiopharmaceutical products

Leak detection
Container Closure Integrity Testing (CCIT) is a crucial step to meet the strict requirements for effective, non-destructive leak testing.

Indicative system image – final design may vary

Container Closure Integrity Tester (CCIT)

 

Want to know more about leak detection?