### Sterility in Health Care Products: Practices and Regulations
Health is a crucial issue, and the quality of products intended for health care is of vital importance. Products labeled as “sterile” must follow a rigorous production pathway designed to ensure that sterility is maintained. This process is based on well-structured practices, strict validations, careful monitoring, and constant controls.
Ideally, sterilization should occur within the sealed barrier system of the product. However, if this approach is not feasible, aseptic processing is adopted, a practice that ensures sterility through the implementation of extremely stringent procedures. Aseptic processing protects the product throughout all phases of the process: from preparation to manufacturing, through filling, and finally sealing in the final containers.
This approach relies on a set of factors that work synergistically to prevent contamination while preserving the integrity of components that have already been sterilized during the delicate stages of assembly and filling. Therefore, it is essential to implement an effective risk management system. This system not only guides the design of the aseptic treatment but also includes the use of advanced technologies such as barrier systems, which are designed to minimize contamination risks.
During aseptic processing, protection of critical areas is guaranteed through various separation systems. These systems serve the primary function of hindering contamination from particles, chemical agents, and microbiological threats, while also ensuring effective separation between operators and the critical processing area.
In this complex context, the EN ISO 13408 series standards provide an important framework. Among these, isolator systems prove to be particularly effective; they offer total physical separation that still allows operator intervention during necessary operations. Thanks to their design, these systems are equipped with sealed gloves and sleeves, enabling operators to work safely without compromising sterility.
A significant recent regulatory development is the adoption of the EN ISO 13408, part 6 standard, which occurred in 2021. This document establishes specific requirements for isolator systems, providing clear and detailed guidelines for their selection and qualification. It includes, among other things, guidelines on bio-decontamination procedures, validation protocols, and operational and control parameters applicable to both health care products and cellular products.
It is important to emphasize that the UNI EN ISO 13408-6 standard has been designed to integrate with the existing regulatory framework, without replacing national legislative requirements or good manufacturing practices (GMP) or the specific requirements of various jurisdictions, whether national or regional.
Another aspect to consider is that the EN ISO 13408-6:2021 standard is recognized as part of the harmonized standards within the European Regulations concerning Medical Devices and In Vitro Diagnostic Medical Devices.
In conclusion, the issue of sterility in health care products requires particular attention and strict compliance with current regulations. Aseptic practices, supported by innovative systems and updated regulations, are fundamental to ensuring the safety and effectiveness of such products.
We invite you to follow us on our social media profiles for further updates and insights on the topic of sterility and health care. Your curiosity and engagement can make a difference in spreading a culture of informed and conscious health awareness.
