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- Title
Validation Required for Quality Assurance of Ultra-low Temperature Freezers in CO VID-19 Vaccination Sites.
- Authors
Keisuke Saso; Chiyomi Okamoto; Naoki Yoshikawa; Yuichiro Kurone; Naoto Hirata; Sadahiko Shimoeda
- Abstract
Many cases of vaccine disposal for Coronavirus Disease 2019 (COVID-19) have been reported. Insufficient quality validation of ultra-low temperature freezers was considered the cause of disposal. To prevent vaccine disposal, we recommend CSV (Computerized System Validation) for appropriate ultra-low temperature freezer management at vaccination sites. We performed a cause analysis of vaccine disposal cases at COVID-19 vaccination sites. We surveyed the websites of four ultra-low temperature freezer manufacturers to determine if sufficient information was supplied to implement CSV. A questionnaire survey was conducted of the four manufacturers to identify educational training provided during ultra-low temperature freezer installation at COVED-19 vaccination sites. In addition, whether Installation Qualification (IQ), Operational Qualification (OQ), and periodic equipment inspections were implemented. Review of vaccine disposal cases revealed human error as the most common cause, attributed to deficiencies in staff education and training. A survey of the four manufacturers' websites revealed functional and performance information was available on all websites, as well as response procedures and contact information for abnormal situations. However, only a few websites posted instruction manuals and quality system certification information. According to the survey results, education and training were conducted both face-to-face and written materials were distributed, however, IQ/OQ and periodic inspection were not conducted. Implementing CSV requires money and time. For this reason, CSV implementation is given a low priority. However, implementing appropriate CSV will lower the risk of vaccine spoilage thus limiting economic and health costs.
- Subjects
COVID-19; QUALITY assurance; VACCINATION; COVID-19 vaccines; COVID-19 pandemic
- Publication
Pharmacometrics / Ōyō Yakuri (0300-8533), 2022, Vol 103, Issue 3/4, p97
- ISSN
0300-8533
- Publication type
Article