ISO 18589-7 Radionuclide Purity Testing of Cesium-137 & Iodine-131
The testing of radionuclides, particularly Cesium-137 (Cs-137) and Iodine-131 (I-131), is critical for ensuring the quality and safety of radiopharmaceuticals used in nuclear medicine. ISO 18589-7 specifies procedures for determining radionuclide purity, which ensures that these radiopharmaceuticals meet stringent international standards for medical use.
Our laboratory adheres strictly to this standard, providing accurate and reliable testing services using state-of-the-art equipment. The process involves multiple steps: preparation of the sample, measurement of the isotopic composition, and analysis of the results against the specified thresholds outlined in ISO 18589-7.
The importance of this testing cannot be overstated. Errors or deviations from these standards can lead to incorrect dosing, which may result in adverse effects on patients. Our team ensures that every test is conducted with precision and attention to detail, using the latest technology available.
For Cesium-137, the purity testing focuses on ensuring that the radioisotope meets the specified requirements for its use in radiation therapy or other medical applications. Similarly, Iodine-131 testing ensures that the isotopes used in thyroid treatments are pure and free from contamination.
The standard specifies a series of tests to determine radionuclide purity, including measurement of activity, determination of half-life, and verification of isotopic composition. These tests ensure that the radiopharmaceuticals meet international standards for medical use as defined by ISO 18589-7.
Our laboratory uses advanced gamma spectrometry systems to perform these analyses. The equipment is regularly calibrated and maintained to ensure accurate results. Our team of experts ensures that each sample undergoes thorough testing, providing clients with confidence in the quality and safety of their products.
| Parameter | Measurement Method | Acceptance Criteria |
|---|---|---|
| Cesium-137 Purity | Gamma Spectrometry | ≤ 0.5% impurities |
| Iodine-131 Purity | Gamma Spectrometry | ≤ 0.2% impurities |
The results of these tests are reported in a detailed and comprehensive manner, providing clients with all the necessary information to ensure compliance with international standards.
International Acceptance and Recognition
The ISO 18589-7 standard is widely recognized and accepted globally for its stringent requirements in radionuclide purity testing. This ensures that the results obtained from our laboratory are universally acceptable, enhancing the trustworthiness of your products.
Our compliance with this international standard not only enhances the reliability of your radiopharmaceuticals but also facilitates easier regulatory approvals and market access. Many countries require adherence to ISO standards for quality assurance in medical applications, making this testing essential for manufacturers looking to export their products internationally.
The acceptance of our results by regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) further reinforces the credibility and reliability of our services. This means that when you choose us, you are choosing a partner who ensures your compliance with global standards.
Environmental and Sustainability Contributions
- Our testing process minimizes waste generation by reusing and recycling as much equipment as possible.
- We adopt energy-efficient practices in our laboratory to reduce carbon footprint.
The purity of radiopharmaceuticals is crucial not only for patient safety but also for the environment. By ensuring that these isotopes are pure, we help minimize the potential for contamination and ensure that any waste generated is minimal and manageable.
Our commitment to sustainability extends beyond just minimizing our own environmental impact. We work closely with manufacturers to ensure that their products meet not only regulatory standards but also environmental best practices.
Use Cases and Application Examples
- Treatment of thyroid cancer using Iodine-131.
- Radiation therapy for various types of cancer using Cesium-137.
| Use Case | Description |
|---|---|
| Treatment of Thyroid Cancer with Iodine-131 | Iodine-131 is used to treat hyperthyroidism and thyroid cancer. Our testing ensures that the isotopes are pure, reducing the risk of side effects. |
| Radiation Therapy with Cesium-137 | Cesium-137 is used in brachytherapy to treat various types of cancer. Our testing ensures that the isotopes are pure, enhancing treatment efficacy and patient safety. |
