The pre-sterilisation paradox
Apart from the legal need to comply with the regulatory requirements governing sterile manufacturing of medical devices, manufacturers need to appreciate the inactivation kinetics of sterilisation technologies. They must also understand the types of viable and non-viable contamination and their effects on the human body. Manufacturers are advised to determine their cleanliness requirements as a result of a formal risk analysis exercise. A review and assessment of control plans with microbiologist support is strongly encouraged.
At first sight, the need to control the pre-sterilisation contamination on a product that will be terminally sterilised seems paradoxical. Peter Rose, managing director, High Edge Consulting, and Synergy Health’s Mark Botting explain the whys and wherefores.
It stands to reason that manufacturers of medical devices should control the contamination of products they are manufacturing and this is particularly true for sterile products. Regulations fall under two broad umbrellas: the Quality Management System (QMS) requirements and the Regulatory requirements. It is not always easy to separate these as one is often a function of the other. Contamination control should be approached holistically in any case, but for the purposes of this article they are mentioned separately.
QMS requirements mandate manufacturers to maintain control of the manufacturing environment with regard to contamination. For the USA, this is laid down by 21 CFR 820.70(c) which states: “(c) Environmental control. …the manufacturer shall establish and maintain procedures to adequately control these environmental conditions…” For Europe, Canada and other key world markets the requirements are covered by ISO 13485:2003 paragraph 6.4, which states: “Work Environment: The organisation shall determine, and manage the work environment needed to achieve conformity to product requirements.”
The Medical Devices Directives, applicable in Europe, but also the basis for similar regulation in other key world markets, have specific requirements concerning microbial contamination.
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