Table 1. Comparison of Cobalt-60 Sterilization Alternatives.
Type of
Sterilization |
Advantages | Challenges |
---|---|---|
Gamma radiation | • Can be used to sterilize health care products on a
commercial scale 1 • Simplicity and reliability of irradiation equipment, the radiation source and ability to match source strength to production throughput ( http://www. iaea.org/inis/collection/NCLCollectionStore/_ Public/07/220/7220308.pdf#page=280) • Scalability for different throughput • Reactor-produced from metal 59Co, and therefore has a finite production cost ( http://www. iaea.org/inis/collection/NCLCollectionStore/_ Public/07/220/7220308.pdf#page=280) |
• Not suitable for small scale
22
• Requires requalification of irradiator operation after source replenishments 23 • Some deleterious effects on patient-care equipment associated with gamma radiation include induced oxidation in polyethylene and delamination and cracking in polyethylene knee bearings 22 |
Electron beams
(E-beam) |
• Can be used to sterilize health care products on a
commercial scale 1 • Near instantaneous dose delivery • Scalability for different throughput • Capability to integrate in an on-line process 3 • Short processing time 23 |
• Higher costs for accelerator investment and
operations than gamma – not suitable for small scale 22 • Complex irradiation equipment design and higher maintenance costs / downtime than Co-60 • Low penetrability (bulk densities up to 0.25 g/cm3) 23 • Dose distribution through the irradiated product is less uniform than with gamma radiation 1 |
X-rays | • Comparable penetration to gamma rays
3,
23
• Recent developments in high current e-beam accelerators for X-rays 3 make it more practical |
• Limited use, uncertain operating and usage cost
estimates 3 • Higher costs for accelerator investment and operations than e-beam and gamma – not suitable for small scale 22 • Complex irradiation equipment design and potentially higher initial capital costs than gamma and higher maintenance costs / downtime than E-beam and Co-60 23 • Accelerator source used for x-ray is less reliable than Co-60 for cargo container contraband and security screening applications ( http://www. iaea.org/inis/collection/NCLCollectionStore/_ Public/29/057/29057259.pdf) |
Ethylene oxide | • Widest range of material compatibility except for
moisture and temperature-sensitive materials (>30 degrees C and/or <30% RH) 23 |
• Hazardous (toxicity issues, explosive)
23
• Long processing time 23 • Many variables to control (temperature, time, pressure, vacuum, gas concentration, packaging and humidity) 3, 23; • Time-consuming for routine use between patients 22 • Package and all parts of product to be sterilized must be gas permeable, irrespective of density 23 |
Steam | • Preferred for aqueous preparations only
3;
• Economical and short processing time; • Nontoxic and safe for the environment 12 |
• Strict temperature and moisture controls;
• Many variables to control (temperature, time, pressure, vacuum, packaging and humidity) 3; • Cannot be used for heat-sensitive materials 22 |
Peracetic acid-
ethanol |
• Established sterilization of bone, dermis and
amniotic membrane transplants with no evidence of impaired transplant properties 1 • Rapid sterilization time 22 • Less damaging process to delicate materials than steam; • Compatible with a wide variety of materials-plastics, rubber, and heat-sensitive items; • Single-use process, there is no possibility of contamination 12 • Faster cycle times than EO 22 |
• Has caused significantly reduced biomechanical
strength and decreased remodeling activity in anterior cruciate ligament reconstruction tendon grafts 1 • Lack of evidence on reduction in infection risk and link to improved patient care 22 |
Thermodisinfection | • Found to preserve tensile strength necessary for
clinical purposes 1, 27 |
• Small-scale |
Microwave | • Effective for sterilization of bone allografts processed
from femoral heads contaminated with Gram-positive and Gram-negative bacteria 1 |
• Lack of evidence on efficacy
1
• Can only be used with items that do not melt 22 |