Sterilization Method	Advantages	Disadvantages
Steam	Non-toxic to patients, personnel, and environment. Cycle is easy to control and monitor. Fast microbial kill. Penetrates medical packaging and device lumens.	Harmful to heat-sensitive instruments/devices. Microsurgical instruments damaged by repeated exposure. May leave instruments wet, causing rust. Potential for burns. Incompatible with most medical devices due to heat sensitivity of plastics. Cannot fully destroy pyrogens on endotoxin-contaminated products.
Ethylene Oxide (EO)	Penetrates packaging materials and device lumens. Optimal material compatibility (Low temp). “Product can be sterilized in its sealed final packaging.” Simple operation and monitoring. Broad microbicidal activity. Low temperature. Sterility assurance and therapeutic effect. Allows immediate product release after processing (Parametric Release), shortening turnaround time, helping to get products to market quickly. Customizable number of single-use disinfectable products. Always meets product and regulatory requirements.	Requires aeration time to remove ETO residues. ETO is toxic, carcinogenic, and flammable. ETO emissions are regulated by US states and Europe. Long cycle/aeration time.
Hydrogen Peroxide (H?O?)	Safe for environment and healthcare personnel. Leaves no toxic residues. Used for heat- and moisture-sensitive items (process temperature $<50^{\circ}\text{C}$). Easy to operate, set up, and monitor. Compatible with most medical devices. Only requires a power socket. Microbicidal efficacy data. Capable of sterilizing electronic components and batteries. Short aeration time.	Cannot sterilize cellulose (paper), linen, and liquids. Few validated single-use medical devices. Size limitations (fewer single-use disinfectable products). $\text{H}_2\text{O}_2$ concentration $>1 \text{ ppm TWA}$ may be toxic.
Dry Heat	No risk of metal corrosion after sterilization. No need for aeration time and residual testing.	Slow sterilization process. Sterilization process is difficult to control within a precise temperature range.
Formaldehyde	Faster cycle time compared to EtO. Lower cost per cycle than EtO. Most items can be used immediately after sterilization.	Vapor is extremely irritating to the eyes. Working temperature is higher than EtO. Formaldehyde residue may remain on sterilized items, potentially harmful to patients. $\text{RH}$ needs to be $\sim 75\%$ for efficacy, as the gas must dissolve in the water film around bacteria. Toxicity. Not FDA approved; recognized only in certain countries.
Nitrogen Dioxide (NO2)	Used for heat-sensitive items. Compatible with most plastics. X-ray internal sterilization potential. No cytotoxic residues. Short cycle time (6-12 hours, including aeration). Safe and easy to bring indoors—reduces manufacturing time and cost.	Poor penetration; can penetrate primary packaging but not final packaging. Limited experience (limited industry development); compatibility, product performance, residues, microbial efficacy, and scalability must be assessed. Incompatible with cardboard. Few validated single-use medical devices. FDA not determined to be adequate.

Feature	Gamma Ray	Electron Beam (E-beam)	X-ray
Mode of Action	Isotropic photons; Avg. energy 1.25 MeV	Electron; Typically 10 MeV energy	Photons with almost the same direction; 90% of photon energy approx. 0.3 MeV
Advantages	Compatible with various medical materials. Product can be sterilized in sealed final packaging. Penetrates medical packaging. No residue on sterilized product. No emission regulation. Cold method (minimal temp rise). Easy control. High penetration. Advanced technique. Products can be released immediately (no batch-to-batch testing).	High dose rate and Sterility Assurance Level (SAL) for immediate release. Can penetrate various materials, including foils. Process allows temperature control during irradiation. Well-controlled dose range. Fast process (one minute for small volumes) for immediate full sterilization. Minimal atmospheric impact (small ozone release). Does not require local radioactive source.	Increased photon energy penetration, similar to Gamma. Fast and efficient targeted treatment, facilitating scale-up from cartons to whole pallets. Flexibility (mix products with different dose requirements in same cycle). Reduced material degradation, processing time, and max product dose vs. Gamma/E-beam.
Disadvantages	Individual plastics need assessment. Must avoid Teflon, PFA, PTFE, PP. Adverse effect on gels and adhesives. Requires a nuclear reactor (expensive). Limited dose flexibility. Lower dose rate than E-beam.	Expensive construction cost for E-beam sterilization facility. Penetration is lower than Gamma. Risk of radiolytic byproducts (e.g., ?OH) which may damage raw materials/API/packaging when sterilizing finished products or $\text{API}$s using ? particles.	Limited experience (limited industry development). Compatibility, performance, residues, microbial efficacy, and scalability must be assessed.
Largest Processing Unit	Pallets or boxes	Boxes	Pallets or boxes
Typical Dose Range (Medical Device Density)	25-40 kGy; Ideal: 25-50 kGy	25-50 kGy; Ideal 25-60 kGy	25-35 kGy; Ideal: 25-40 kGy
Dose Rate	A few kGy/h	A few 1000 kGy/h	A few kGy/h to a few hundred kGy/h
Typical Max Temp	45?C-50?C	50?C	35?C-40?C

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