{
  "abstract": "Purpose Tissue-C (AL.CHI.MI.A. S.r.l.) is a corneal storage medium indicated for the storage of human cornea at 31±2°C for up to 30 days. The product is stored between -25°C and -15°C and should be thawed by the user just before use. This study aimed to investigate the impact of different thawing conditions on product specifications.Methods A total of 9 Tissue-C vials, stored at -25°C to -15°C, were divided into three groups and thawed under the following conditions:Group 1: Thawing in a water bath set at 37°C (37±2 °C) for up to 30 minutes until fully thawedGroup 2: Thawing at room temperature (25±2 °C, RT) until fully thawedGroup 3: Thawing at 5°C ± 3 °C (2–8°C, control) until fully thawed.After thawing, the pH, osmolality, and antimicrobials content were measured for each sample. These parameters were also assessed after the storage of the thawed device at 2–8°C for 24 hours. Mean values and standard deviations were calculated for each parameter and compared to the product’s specification range. Data from Groups 1 and 2 were compared to data from Group 3 (control) at each time point (immediately post-thaw, and after 24 hours of storage at 2–8°C) using a Student’s t-test or a non-parametric equivalent.Results The mean values for pH, osmolality, and antimicrobial concentration in the Tissue-C samples were within specification limits after thawing at 37°C (Group 1), room temperature (Group 2), and 2–8°C (Group 3, control). No statistically significant differences were observed between groups 1 and 2 when compared to the control. Additionally, storage of the thawed solutions at 2–8°C for 24 hours had minimal impact on the tested parameters.Conclusions According to the results of the study, Tissue-C can be effectively thawed in a water bath set at 37°C (37±2 °C) for up to 30 minutes, at room temperature (25±2 °C) until fully thawed for up to 4 hours, as well as at 2–8°C overnight immediately before use. Additionally, the storage of the thawed device at 2–8°C for 24 hours could be feasible if necessary.",
  "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.3. Assessment of tissue-C thawing conditions before use",
  "uid": "8dc0b290-3de0-5da5-b215-d15ed16012b2"
}