There are many challenges that arise from choosing steam sterilisation. Lee Simpson, Medical Device Sterile Product Specialist, High Edge Consulting highlights some key considerations when designing cycle development for validation.
Even as the “grandmother” of sterilisation, steam is still a popular choice for the medical device industry. It is still widely used in virtually every central sterilisation department throughout the UK National Health Service, for example. Using steam has its benefits, but it also has its challenges. Steam has the benefits of being very effective and relatively cheap and quick. Saturated steam under pressure is also effective against a wide range of microbes including spores.
The regulatory framework defined in Europe demands that the routine validation steps are followed: Installation qualification (IQ), operational qualification (OP), and performance qualification (PQ). But nestled away inside ISO17665: (Sterilisation of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices) is the requirement for sterilisation development.
Steam is not suitable for many materials due to the high temperatures and pressures involved. To maintain sterility, the devices require packaging that acts as a sterile barrier after the sterilisation process. This means that the cycle has to be suitable, not only for the devices, but also for the associated packaging. To achieve sterility is a relatively routine task, however, the marketing department does not usually like the detrimental outcome to the physical branding displayed on the packaging.
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