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Certain products are not compatible with a terminal sterilization of the product, and therefore require processing under aseptic conditions. HCM Medical has the ability to execute production activities in GMP class A/B/C (ISO 5-7) cleanrooms, and therefore can facilitate production under aseptic conditions.
Understanding aseptic handling
Aseptic handling involves maintaining a sterile environment throughout the production process to prevent contamination. Processing of products under aseptic conditions is executed in line with ISO 13408-1. It’s essential for products that are sensitive to heat or cannot be sterilized after packaging. At HCM Medical, aseptic handling is a carefully monitored process, ensuring the highest safety and quality of our medical products.
Validating the aseptic manufacturing process
Media fills are integral to validating our aseptic manufacturing processes. By means of an extensive aseptic process validation, we can confidently assure that our procedures maintain the highest sterility levels, ensuring the safety and reliability of our final products.
Media fills
During Media fill procedures, we use microbiological growth medium in place of the actual product. This method is essential to simulate real production conditions and verify that our aseptic procedures are robust enough to prevent contamination effectively.
Quality assurance
Quality assurance is a continuous process at HCM Medical. Every six months, our production team undergoes a requalification process. This stringent training ensures that every team member is not only up-to-date with the latest aseptic handling techniques but also masters the nuances of high-quality medical manufacturing. This includes gowning qualification, training on operating procedures, and environmental monitoring.