Meeting the challenge of sterilization

One of the more difficult aspects of suture manufacturing has been the sterilization of synthetic absorbable sutures. Due to their hygroscopic nature and the tendency to bond effectively with EtO in the presence of moisture, they tend to degenerate and lose strength on storage, leading to serious implications for the patient and the surgeon.

The solution, therefore, was a sterilizer that delivered precise moisture levels for effective sterilization. And utilized minimum quantity of EtO gas that was easy to recover at the end of the cycle.

Lotus found the answer in a 100% EtO gas sterilizer from Andersen Products, USA. Andersen is a name to reckon with in the business of sterilization for the past 35 years and has more than 7,000 installations world-wide to its credit.

Andersen uses a unique method for creating humidity. It employs a humidity chip that delivers precise humidity levels directly onto the load to be sterilized, compared to the older method of spraying distilled water into a chamber full of gas.

Andersen Sterilizers use less than 1/6th of the gas compared to other conventional sterilizers. As a result, less gas binds to the suture and is easy to recover at the end of the cycle. This also ensures that lesser amounts of gas are discharged into the environment. As opposed to this, conventional sterilizers using high amounts of gas make the complete recovery of EtO difficult, leading to the presence of residual EtO on the product that could lead to post-operative complications.

The Andersen system, which runs the sterilization process with pre-measured parameters, further simplifies the validation process with respect to humidity, gas levels standard load, gas penetration etc. which is mandatory for international quality systems in sterilization.

As a responsible corporate citizen, Lotus is also committed to environment protection. To this end it has invested in an Abator provided by Andersen Products that neutralizes the discharged EtO into carbon-dioxide and water.