Dear Sir,

We are manufacturers of sterile sutures and based in Bangalore, India. We have been sterilising Polyglycolic Acid [PGA] sutures with the following combination:

GAS MIXTURE: 10% ETO and 90% CO2
MOISTURE/HUMIDITY: 40 TO 50%
TEMPERATURE: 45 TO 50 DEGREE CENTIGRADE
TIME: FOUR HOURS.
PRESSURE: ONE LB.

With above parameters, we have been achieving satisfactory sterilisation results.

We would like to reduce the moisture to the minimum possible. The PGA sutures are highly sensitive to moisture and therefore reducing the moisutre level is highly desirable. The product is stable even at 80 degree centigrade temperature. We cannot change the gas composition, as the equipment can handle the gas mentioned above.

Will you please guide us on the parameters to be adopted on temperature, pressure and time, keeping the humidity at 20 to 30% during the sterile period. Longer sterilisation period is acceptable, if lower humidity levels are prevailing.

with regards,

A.D.SETTY
EXEUTIVE CHAIRMAN
FUTURA SURGICARE PVT LTD
29, FIRST MAIN, KGE LAYOUT,
RMV II STAGE, BANGALORE-94
INDIA

Dear Setty A.D.

You might find an answer to your question if you contact the ETO Sterilization Association (EOSA). The EOSA is a non-profit organization whose members include medical device manufacturers with a common interest in the use of ethylene oxide. www.eosa.org
Another source might be the Medical Devices link website: www.devicelink.com
You can find an interesting article "Synthetic Biodegradable Polymers as Medical Devices (MPB) archive, Mar 98)". with references to related articles. The website offers a Q/A and a Marketplace Discussion Forum for registered users.
I hope you get the answer you're looking for.

Best regards
Josy Holdener