Evaluation of Sterilization Performance for Vaporized-Hydrogen-Peroxide-Based Sterilizer with Diverse Controlled Parameters

Abstract

Hydrogen-peroxide-based low-temperature sterilization is a new sterilization technology for temperature-dependent medical devices. The effect of the process parameters of hydrogen-peroxide-based sterilizer on the sterilization performance of process challenge devices (PCDs) needs to be investigated. Sterilant amount, operating temperature, vacuum pressure, diffusion time, and chamber loading of the sterilizer on the sterilization performance of PCDs were adjusted. Seven PCDs with various morphologies and material containing biological indicators (BI) (EZTest, Geobacillus stearothermophilus) were used to evaluate the sterilization performance. The sterilization success rates of PCDs were 86, 71, and 57% with controlled temperature and pressure, diffusion time, and sterilant volume injection, respectively. The PCD material and structure also obviously affected sterilization performance. The sterilization of PCD A is the least successful for all parameters. Meanwhile, the sterilization of PCD B was influenced by the diffusion time and the sterilant injection volume. PCD B and PCD C were successfully sterilized by controlling the temperature and pressure. The weights and volume of the sterilization loading chamber resulted in a different sterilization performance. Sterilization performances of PCD 1, PCD 2, and PCD 3 were <70, <90, and 100%, respectively. Sterilant volume, sterilant diffusion time, pressure, temperature, PCD types, and chamber loading were proven to be important process parameters of sterilizer that affect the sterilization performance of vaporized-hydrogen-peroxide-based sterilizers.

Sterilization of Polymeric Implants: Challenges and Opportunities

“…Hydrogen peroxide (H 2 O 2 ) is a class B chemical sterilant. , Its microbial killing mechanism involves the induction of reactive oxygen species (ROS) which can cause broad damages to the DNA, protein, and membrane components of the contaminating microbes. , H 2 O 2 is typically applied as gas plasma or in a vaporized state at 40–65 °C and 25–50 °C, respectively, for 1–3 h. , It is more commonly used in surface cleaning than in manufacturing class III medical devices. Examples of its device applications are PMMA bone cements or prostheses composed of PMMA for which H 2 O 2 gas plasma may be used as an alternative to EtO sterilization. ,, …”

“…Benefits of H 2 O 2 sterilization are similar to those of other chemical sterilants, including relatively low operating temperatures and better compatibility with heat sensitive polymers. , Compared to EtO gas, however, vaporized H 2 O 2 has less effective penetration of porous scaffolds ,,,, Furthermore, although deliberate H 2 O 2 incorporation the in polymeric scaffold may be leveraged for certain drug delivery or tissue engineering applications, the hydroxyl free radical generated during H 2 O 2 sterilization has the potential to oxidatively cross-link polymers, resulting in deleterious changes. ,, Studies characterizing the morphological and biochemical changes induced by H 2 O 2 sterilization in UHMWPE revealed changes similar to those induced by gamma irradiation, including embrittlement . H 2 O 2 sterilization has also been observed to induce mechanical and degradative property changes to degradable polymers such as PLA. ,, Lastly, it is of note that H 2 O 2 sterilization was found to be ineffective when paired with cellulose-based products due to the high tendency of cellulose to absorb H 2 O 2 , thereby reducing its effective concentration .…”

“…2,35,65 Benefits of H 2 O 2 sterilization are similar to those of other chemical sterilants, including relatively low operating temperatures and better compatibility with heat sensitive polymers. 2,34 Compared to EtO gas, however, vaporized H 2 O 2 has less effective penetration of porous scaffolds 2,34,35,65,66 Furthermore, although deliberate H 2 O 2 incorporation the in polymeric scaffold may be leveraged for certain drug delivery 67 or tissue engineering applications, 68 the hydroxyl free radical generated during H 2 O 2 sterilization has the potential to oxidatively cross-link polymers, resulting in deleterious changes. 35,68,69 Studies characterizing the morphological and biochemical changes induced by H 2 O 2 sterilization in UHMWPE revealed changes similar to those induced by gamma irradiation, including embrittlement.…”

“…Examples of its device applications are PMMA bone cements or prostheses composed of PMMA for which H 2 O 2 gas plasma may be used as an alternative to EtO sterilization. 2,35,65 Benefits of H 2 O 2 sterilization are similar to those of other chemical sterilants, including relatively low operating temperatures and better compatibility with heat sensitive polymers. 2,34 Compared to EtO gas, however, vaporized H 2 O 2 has less effective penetration of porous scaffolds 2,34,35,65,66 Furthermore, although deliberate H 2 O 2 incorporation the in polymeric scaffold may be leveraged for certain drug delivery 67 or tissue engineering applications, 68 the hydroxyl free radical generated during H 2 O 2 sterilization has the potential to oxidatively cross-link polymers, resulting in deleterious changes.…”

Natural Polymers and Their Processing: Bottlenecks to Overcome Their Limitations in Medical Applications

“…In recent decades, hydrogen peroxide plasma gas sterilization has gone from a promising approach to become one of the main sterilization techniques for biomaterials sensitive to high temperatures [86,[106][107][108][109][110][111]. The main benefits of hydrogen peroxide plasma gas are highly efficient sterilization, safety (free from toxic chemical residues), and quickness, and it could be performed at temperature range of 37-44 °C, low humidity, and it can be used in a wide range of biomaterials [107,108].…”