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International Journal of Bioprinting        Guide about the effects of sterilization on 3D-printed materials for medicine



            Table 2. Mechanical properties and methods used according to manufacturer for each material and 3D printing technology used
            Parameters     Manufacturer                  Mechanical properties according to manufacturer
                                      Tensile   Young’s   Elongation  Glass transition  Shore   Methods
                                      strength  modulus   at break   temperature (Tg)  hardness
                                      (MPa)  (MPa)   (%)      (°C)
            PLA (Manufacturer) Kimya  22.9  2.097       4.2   107         76.8D  ISO 527-2/5A/50, ISO 178, ISO 868
            ABS            Kimya      35.3  1443        9.8   107         70.0D  ISO 527-2/5A/50, ISO 178, ISO 868
            TPU/TPE (Filaflex   Recreus  26  2.5     950      –           63A    DIN ISO 7619-1, DIN 53504-S2
            60A Pro)
            PA12           3D Systems  43   1387       14     192         73D    ASTM D638, ASTM D790, ASTM D2240
            Elastic 50     Formlabs     3.23  1.59   160      –           50A     ASTM D 412-06 (A), ASTM 2240

            Flexible 80    Formlabs     8.9  6.3     120      27          80A    ASTM D 412-06 (A), ASTM 2240
            Durable        Formlabs   28    1000       55     –           –      ASTM D638-14, ASTM D 790-15
            Surgical Guide  Formlabs  73    2900       12.3   –           67D    ASTM D790, ASTM D638
            Elastic Clear  Stratasys  3–5   –        360–400  –           45A    ASTM D-412, ASTM D-395, ASTM D-2240
            MED610         Stratasys  50–65  2000–3000 10–20  54          86D    ASTM D-638-03-04-05, D-790-04, DMA E
            VERO           Stratasys  40–55  2000–2500 15–20  54          86D    ASTM D-638-03-04-05, D-790-04, DMA E
            Abbreviations: ABS, acrylonitrile butadiene styrene; PLA, polylactic acid; TPE, thermoplastic elastomer; TPU, thermoplastic polyurethane

            which depends on its glass transition temperature (Tg),   2.3.2. Autoclave 121
            can be known from the manufacturing technical file. The   Autoclave 121 (AU121) is a process that uses a temperature
            sterilization methods performed to each material samples   of 121°C for sterilization. The sterilization process involves
            can be found in Table S1 (Supplementary File).     the following steps:
            2.3.1. Hydrogen peroxide                            (1)  Preheating:
            HPO sterilization is a low-temperature chemical         •  Air removal: The air inside the autoclave is removed
            sterilization process that uses HPO as the sterilant. The   through a vacuum cycle, which helps to improve
            process involves the following steps:                     steam penetration. This stage lasts for 2–5 min.

             (1)  Prevacuum phase: Air is removed from the          •  Steam injection: Steam is introduced into the
                 sterilization chamber to prepare for the introduction   autoclave and the pressure and temperature begin
                 of HPO. This phase lasts for 3–5 min.                to rise. This stage lasts for 5 min.
             (2)  Pulse  phase:  A  measured  amount  of  HPO  is    (2)  Holding time: The temperature and pressure are
                 introduced into the sterilization chamber. The HPO   maintained around 121°C and 2.5–3 atm, respectively,
                 vaporizes and begins to penetrate and sterilize the   for 20 min. This is the time required for the steam to
                 equipment and contents. This phase lasts for 3–5 min.  penetrate and kill any microbial organisms.

             (3)  Pressure holding phase: The pressure inside the    (3)  Depressurization: The pressure inside the autoclave
                 sterilization chamber is maintained for a specified   is reduced back to atmospheric pressure. This step
                 period of time to allow the HPO to penetrate and   lasts for 10 min.
                 sterilize the equipment and contents. This phase lasts
                 for approximately 30 min.                      (4)  Drying: The items inside the autoclave are dried.
                                                                    This stage lasts for 15 min.
             (4)  Decontamination phase: The HPO is then neutralized
                 and  removed  from  the  sterilization  chamber.  This   The maximum pressure reached is 2.5–3 atm, and the
                 phase lasts for 10 min.                       temperature reached during the cycle is 121°C.
            During the HPO sterilization cycle, the temperature   2.3.3. Autoclave 134
            reaches 60°C, while the maximum pressure reached is   Autoclave 134 (AU134) is a process that uses a higher
            around 69 kPa.                                     temperature for sterilization. The sterilization process


            Volume 9 Issue 5 (2023)                        149                         https://doi.org/10.18063/ijb.756
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