Sterilization and disinfection methods for decellularized matrix materials: Review, consideration and proposal

Sterilization and disinfection are essential to ensure aseptic conditions in biomedical applications. However, these processes can alter the physical and chemical properties of biomaterials. Decellularized matrix (dECM) is a promising material due to its low immunogenicity and retention of native tissue components. Despite its potential, limited research has explored how sterilization or disinfection affects dECM. Prior studies have established the importance of aseptic conditions in clinical and experimental settings, but no prior work has systematically analyzed sterilization methods for dECM. This gap motivated a comprehensive review to address the lack of standardized protocols. The absence of detailed guidance on selecting and validating sterilization methods for dECM remains a critical issue. Understanding how sterilization impacts dECM’s structure and function is essential for its clinical translation. This paper aims to bridge the knowledge gap by providing a structured overview of current sterilization practices.

This study aims to systematically evaluate sterilization and disinfection methods for decellularized matrix materials. The primary goal is to analyze the mechanisms, advantages, and limitations of various techniques. The authors seek to identify factors influencing the choice of sterilization methods for dECM. They also aim to summarize existing protocols for different types of dECM. The study proposes a graphical decision route for selecting appropriate sterilization methods. Additionally, it outlines a technical validation process for chosen methods. This approach is intended to guide researchers and clinicians in choosing optimal sterilization strategies. The review fills a critical gap in the literature by providing a structured framework for sterilization of dECM.

The authors conducted a comprehensive review of existing literature on sterilization and disinfection methods for dECM. They analyzed the mechanisms, advantages, and disadvantages of various techniques such as gamma irradiation, ethylene oxide, and chemical disinfectants. The study compared the impact of each method on dECM’s structural and functional properties. The authors evaluated factors influencing sterilization method selection, including material type and intended application. They synthesized findings from multiple studies to identify common trends and challenges. The review also included a discussion on validation protocols for sterilization methods. The authors proposed a graphical route to guide method selection based on dECM characteristics. The study concludes with a technical framework for validating chosen sterilization strategies.

The review highlights that gamma irradiation is effective but may degrade dECM components. Ethylene oxide is less damaging but requires careful handling due to toxicity. Chemical disinfectants like glutaraldehyde show variable effects depending on concentration. The study found that sterilization methods significantly affect dECM’s mechanical and biological properties. The authors report that no single method is universally optimal for all dECM types. They observed that factors like dECM source and intended use influence method selection. The proposed graphical route provides a decision-making tool for sterilization. The validation framework includes testing for sterility and functional integrity of dECM.

The authors conclude that sterilization and disinfection methods must be carefully selected based on dECM characteristics and application needs. They emphasize that no single method is suitable for all dECM types. The proposed graphical route offers a practical guide for method selection. The validation framework ensures that sterilization does not compromise dECM functionality. The study suggests that further research is needed to optimize sterilization protocols for specific dECM types. The authors propose that standardized protocols could improve clinical outcomes. They highlight the importance of balancing sterility with material integrity. The findings provide a reference for researchers and clinicians working with dECM.