Sterilizing instruments with Ethylene Oxide (ETO) requires precise conditions: maintaining a concentration of 600 ± 50mg/l and a controlled temperature between 54°C to 55°C for 6 hours. Additionally, humidity levels must remain at 60-70% relative humidity (RH) throughout the process for optimal results. These stringent parameters ensure thorough sterilization, vital for maintaining safety and integrity in medical and laboratory settings. ETO sterilization is a critical method, offering effective decontamination for a wide range of instruments, ensuring they meet stringent standards for use in healthcare and research environments.
When transporting products, it's essential to use suitable cardboard boxes for packaging. During transportation, it's imperative to adhere to specific temperature parameters. The minimum temperature for transportation should not fall below 10°C, while the maximum temperature should not exceed 40°C to maintain product integrity. For storage purposes, similar temperature constraints apply. The minimum temperature for storage should be maintained at 5°C to prevent any adverse effects on the products. Conversely, the maximum storage temperature should not surpass 40°C to ensure product stability and quality retention throughout the storage period.
ISO Class 7 cleanrooms adhere to ISO 14644 standards, offering meticulously controlled environments for industries requiring high cleanliness. Equipped with HEPA or ULPA filters in ceiling-mounted FFUs, they maintain low particle counts. Controlled airflow minimizes particle dispersion, while continuous environmental monitoring ensures conditions meet standards. Strict entry procedures, including gowning and air showers, reduce contamination risk. Regular maintenance sustains cleanliness and ISO compliance. These cleanrooms are vital for pharmaceuticals, biotechnology, and microelectronics, ensuring precision and reliability in critical processes.
Sterile instruments typically have a shelf life of five years, though this can vary based on instrument type and storage conditions. They are often packaged in materials like Tyvek or medical-grade paper, sealed to prevent microbial contamination. Storage in clean, dry environments away from extremes of temperature and light is crucial for maintaining sterility. Regular inspections and quality control measures ensure integrity throughout the shelf life. This balance of packaging, storage, and monitoring ensures that sterile instruments remain effective and safe for medical and laboratory use.
