The use of Single Use Systems (SUS) has risen over recent years, in parts due to the increased production of parenteral products as a consequence of the pandemic. SUS are considered as critical components, their use requires a thorough qualification of the manufacturer.
The use of Single Use Systems (SUS) has risen over recent years, in parts due to the increased production of parenteral products as a consequence of the pandemic. SUS are considered as critical components, their use requires a thorough qualification of the manufacturer.
As a result, authorities have heightened their focus and expectations on the correct application of SUS for the production of sterile medicinal products.
This has led to a rise in demand for single use systems supplier audits that is expected to continue in the future.
SUS can be individual components or assemblies of bags, filters, tubes, aseptic connectors, valves or sensors and are supplied sterile or non-sterile. They are usually used in upstream and downstream biotechnological processes and in fill-and-finish processes of sterile drug products.
Due to the lack of official guidelines describing the good manufacturing practices (GMP) for SUS, manufacturers usually have quality management systems according to ISO 9001 or ISO 13485 in place and perform gamma sterilization in accordance with ISO 11137 series.
As a result of the increase in the use of SUS, the revision of Annex 1 of EU GMP for the manufacture of sterile medicinal products which came into effect on 25 August 2023 includes now also a dedicated section about “Single Use Systems” (8.131 – 8.139) and refers to the criticality of qualifying SUS suppliers.
The SUS section describes that:
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specific risks associated with SUS should be assessed as part of the Contamination Control Strategy,
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the sterilization process of SUS must be validated,
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the absorption and reactivity of product with contact surfaces and extractable and leachable profiles of SUS should be evaluated,
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attention to the structural integrity of the SUS is important,
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acceptance criteria should be established and that upon receipt and before use SUS must be inspected,
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critical manual operations of SUS should be verified during aseptic process simulations, and
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assessment and qualification of SUS suppliers is critical.
Audits of SUS manufacturers assess compliance of the manufacturer’s quality management system against ISO 9001 or ISO 13485 (depending on the QMS of the supplier). To compensate for the absence of more specific guidelines, audits should always assess closely the SUS user’s requirements with regard to function, integrity, extractables & leachables, particles, endotoxins, bioburden resp. sterility and reliability of supply. The validation of the sterilization process and qualification of the sterilization service supplier by the SUS manufacturer are additional important topics during an audit.
blue inspection routinely performs audits of different types of SUS manufacturers worldwide. Our auditors are familiar with the medicinal product manufacturer’s requirements and perform risk-based audits accordingly.
