{
  "abstract": "Purpose XTRA·4 (AL.CHI.MI.A. SRL) is a medical device under development, intended as corneal storage medium for the preservation of human corneas at 2–8°C for up to 14 days. During the development of a medical device, it is mandatory to assess various regulatory aspects, including performance, safety and stability of the device, to obtain market authorization. This study aimed to assess the stability of the device over its 24-month shelf life at 2–8°C, including an evaluation of the medium and primary packaging components, as well as its safety through biocompatibility studies.Methods A total of 14 XTRA·4 vials were included in an accelerated aging study at 25°C ± 2°C for 6 months, to simulate product storage at 2–8°C for 24 months, based on the Arrhenius equation with a Q10 aging factor of 2. The appearance and characteristics of the vials, as well as pH, osmolality, endotoxin levels, sterility, and antimicrobial content, were measured immediately after manufacturing (T0) and after 3 months (n=3 vials) and 6 months of accelerated aging (final time point, n=11 vials). Additionally, biocompatibility was assessed through cytotoxicity test following the ISO 10993–5 guideline, skin sensitization (GPMT) according to the ISO 10993–10 guideline, and ocular irritation testing in accordance with the ISO 10993–23 guideline.Results The appearance and characteristics of the XTRA·4 vials, as well as pH, osmolality, endotoxin levels, sterility, and antimicrobial content, remained within specification limits at both the intermediate 3-month and final 6-month time points during the accelerated aging study at 25°C ± 2°C. Additionally, the product was found to be non-cytotoxic, non-sensitizing, and non-irritant according to the ISO 10993–5, ISO 10993–10, and ISO 10993–23 guidelines, respectively.Conclusions Based on the study results, XTRA·4 maintained all tested parameters within specification limits throughout the accelerated stability study, supporting a predicted shelf life of 24 months at 2–8°C. Furthermore, the product was shown to be safe, as it exhibited no cytotoxic, sensitizing, or irritant effects.",
  "authors": [
    {
      "affiliations": [
        "Research and Development, AL.CHI.MI.A. SRL, Ponte San Nicolò, Italy"
      ],
      "name": "Laura Giurgola"
    },
    {
      "affiliations": [
        "Research and Development, AL.CHI.MI.A. SRL, Ponte San Nicolò, Italy"
      ],
      "name": "Umberto Rodella"
    },
    {
      "affiliations": [
        "Research and Development, AL.CHI.MI.A. SRL, Ponte San Nicolò, Italy"
      ],
      "name": "Claudio Gatto"
    },
    {
      "affiliations": [
        "Research and Development, AL.CHI.MI.A. SRL, Ponte San Nicolò, Italy"
      ],
      "name": "Jana D’Amato Tóthová"
    }
  ],
  "title": "P.2. Accelerated aging study of a novel medium for corneal storage at 2–8°C",
  "uid": "8655069c-5cac-5bc3-8655-3bd6b655bbcc"
}