The development of radiopharmaceuticals

In the rapidly developing biotechnology industry, the advancement of radiopharmaceuticals represents a significant leap forward in personalized medicine, especially in the field of cancer treatment. Products are generally packaged in glass bottles, which are crucial for the treatment of cancer patients, and have a short half-life, so each unit of medication is very expensive.

Nuclear Medicine: Balancing Safety and Efficiency

Usually, the Food and Drug Administration (FDA) requires the use of deterministic CCIT methods, as this method must have high sensitivity to detect even the smallest defects in the drug bottle, thereby ensuring the integrity of the product. However, the application of nuclear medicine also brings some unique challenges:

Controlled environment:The test must be conducted in a controlled sealed room to prevent radiation leakage, and the room must be pressurized to ensure that any leakage is discharged through the exhaust port. Due to the high value of drugs and limited supply of isotopes, non-destructive testing methods are required so that any small bottles that pass the test can be returned to the production line.

Safety and sealing:CCIT solutions need to be installed in isolation rooms or glove boxes with enhanced radiation shielding. These glove boxes are equipped with large rubber gloves to operate medication bottles and machines while maintaining isolation.

New challenges

When a new type of radioactive tumor drug is introduced to the market, it faces new challenges in leak detection. The testing must be non-destructive and conducted in a radiation safe environment, capable of detecting even the smallest leaks to ensure the integrity and safety of the product.

Solution

Paratronix (Shandong Puchuang Technology) is itsMLT-V100 (T) Micro Leakage Non Destructive Sealing TesterWe provide customized solutions using pressure attenuation testing technology. Ensure a deterministic testing process suitable for sealed pressurized environments, with effective leak control and user-friendly operation.configuredlarge enoughThe human-machine interface（HMI）In order to operate with large rubber gloves or be compatible with remote monitors and input devices. Given the potential risks of even minor leaks, the sensitivity of leak detection in nuclear medicine The CCIT method requires high sensitivity to detect micro defects that may damage product integrity.equipmentPlaced in a sealed chamber within the pressurized chamber, with the aim of safely expelling any potential radiation leaks. By choosing pressure attenuation testing instead of vacuum attenuation testing, contamination and health hazards caused by radioactive liquid vaporization have been avoided. This method can determine without damaging the medicine bottlePass or failAs a result, the passed products can be safely returned to the production line. In addition, the deviceImproved detection efficiency，Operating in a glove box environment ensures safe operation even when wearing large rubber gloves. This tool is designed with ergonomics in mind, making it easy to use within the control unit and ensuring that operators can effectively operate the tool even while wearing gloves. User friendly human-machine interface(HMI) is also designed specifically for glove operation, ensuring accuracy and efficiency of the operation.