|
Sterilization by Ethylene oxide
(ETO)
• ETO is employed for heat and
radiation sensitive materials.
• It is carried out with pure gas or with a gas
admixed with a suitable gas. Gas concentration,
humidity, temperature and process time can appreciably
affect the efficiency of this process.
• Typical parameters may be 900mg ETO/L at 10psi,
50-60 % RH and 6 hours of exposure.
Terminal Sterilization by
radiation
• It is Physical and cold process
• Pre - Packed Finished product is sterilized
• A dose of 25kGy provides a extremely high safety
factor, and when the product has low initial microbial
count, the probability of any microbial survival can
be expected to be less than one in one million
Comparison of ETO and radiation
sterilization
| Factor |
ETO |
Radiation |
| Conditions for
sterilization |
ETO conc. 900mg/l
Temperature 55 °C RH 50-60% Pressure 10psi Time
6hr |
Radiation dose
25kGy
NA
NA
NA |
| Time |
yes |
Yes |
| Post sterilization
degassing period |
7-14 days |
No |
| Choice of packaging |
Narrow |
Wide |
| Sterilizing the
product packed in shipping pack |
Not possible |
possible |
| Penetration power |
low |
Very high |
| Residual toxicity |
yes |
nil |
PRIMARY PACKAGING MATERIAL FOR
RADIATION STERILIZATION
• Impermeable to microorganism
• Good heat sealing property
• Good tear and impact strength
• Clarity and customer appeal
• Stability against radiation
Products commonly sterilized by radiation
• Medical Devices coming
under Class A, B, C and D as specified by CDSCO in MDR
2017
• R & D samples
• Empty plastic bottles, nozzles, caps etc., which are
not coming under CDSCO purview.
• Drugs coming under C &C 1 and other than C &C1 as
per drugs and cosmetics act 1940 and rule 1945
• Ayurvedic and Cosmetic products as approved by CDSCO |
