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X-ray sterilization of biopharmaceutical manufacturing equipment-Extractables profile of a film material and copolyester Tritan™ compared to gamma irradiation.

ABSTRACT: The biopharmaceutical industry gains enormous flexibility in production processes by using sterilized preassembled single-use devices. Gamma irradiation is an established sterilization technology that may be restricted in the future by the availability of ⁶⁰ Co as irradiation source and irradiation capacities. X-ray technology is considered an alternative type of radiation for sterilizing SU equipment. In the context of extractables and leachables-one concern connected with the use of single-use process equipment-the effect of X-ray irradiation on the extractables profile of the materials needs to be compared to established gamma irradiation to qualify this alternative technology. An approach is presented to obtain robust and comprehensive extractables data for materials used in SU devices after sterilization either using X-ray or gamma irradiation. A careful selection of the test items and the test design allows a one-to-one comparison of data obtained from a combination of orthogonal analytical techniques. The extractables of a modern SU film material and the copolyester Tritan™ are evaluated. The data presented allow a risk evaluation on the safety of this new sterilization modality for biopharmaceutical applications. It is demonstrated that the extractables profile of a polymer is not affected by the type of irradiation used for sterilization.

SUBMITTER: Menzel R

PROVIDER: S-EPMC9286515 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic during the fall of 2019 and into the spring of 2020 has led to an increased demand of disposable N95 respirators and other types of personal protective equipment (PPE) as a way to prevent virus spread and help ensure the safety of healthcare workers. The sudden demand led to rapid modification, development, and dissemination of 3D printed PPE. The goal of this study was to determine the inherent sterility and re-sterilizing ability of 3D printed PPE in order to provide sterile equipment to the healthcare field and the general public.MethodsSamples of polylactic acid (PLA), thermoplastic polyurethane (TPU) (infill-based designs) and polypropylene (single-wall hollow design) were 3D printed. Samples were inoculated with E. coli for 24 h and then sanitized using various chemical solutions or heat-based methods. The samples were then incubated for 24- or 72-h in sterile LB medium at 37°C, and bacterial growth was measured by optical density at 600nm. Statistical analysis was conducted using GraphPad Prism v8.2.1.ResultsSignificant bacterial growth was observed in all PLA and TPU based samples following re-sterilization, regardless of the methods used when compared to controls (p < 0.05). The single-walled hollow polypropylene design was not only sterile following printing, but was also able to undergo re-sanitization following bacterial inoculation, with no significant bacterial growth (p > 0.05) observed regardless of sanitization method used.ConclusionThe cost effectiveness, ease of sanitization, and reusability of 3D printed PPE, using our novel single-walled polypropylene design can help meet increased demands of PPE for healthcare workers and the general public that are needed to help decrease the viral transmission of the coronavirus disease of 2019 (COVID-19) pandemic. 3D printing also has the potential to lead to the creation and production of other sterile material items for the healthcare industry in the future. The ability to re-sterilize 3D printed PPE, as our design shows, would also contribute less to the increase in biomedical waste (BMW) being experienced by COVID-19.

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X-ray sterilization of biopharmaceutical manufacturing equipment-Extractables profile of a film material and copolyester Tritan™ compared to gamma irradiation.

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