DE LAMA PRESENTS: HYPERPURE® TECHNOLOGY- article published on Innovabiomed Magazine

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It is a low temperature sterilization process that represents the real alternative to ETO (Ethylene Oxide) and Gamma Ray sterilization, and offers important advantages over these more traditional techniques. Interview with Marco Bianchi – Marketing, Communications & Sales Manager at De Lama S.p.A.

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Article extracted from the July issue of Innovabiomed Magazine, the official magazine of Innovabiomed, in collaboration with the Biomedical District of Mirandola and sponsored by Confindustria Medical Devices

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Translation in English language

DE LAMA PRESENTS: HYPERPURE® TECHNOLOGY

It is a low temperature sterilization process that represents the real alternative to ETO (Ethylene Oxide) and Gamma Ray sterilization, and offers important advantages over these more traditional techniques. Interview with Marco Bianchi – Marketing, Communications & Sales Manager at De Lama S.p.A.

Is this new system capable of completely replacing ethylene oxide and gamma ray sterilization?

Absolutely yes. The only limit is the secondary double-wave cardboard packaging, but in this case the medical device manufacturers simply reverse the order of the process: first they sterilize the products (normally contained in the primary packaging with Tyvek or medical paper side) and then pack in corrugated cardboard in case secondary packaging is required. Some high-end manufacturers directly have secondary plastic packaging in microcannulas that can be directly inserted into our HyPerPure sterilization system.

Is it possible, even today, to use it instead of current systems and what advantages does it offer? Is it already available on the market?

Yes. The product is already on the market, used both in the pharmaceutical sector (used in particular for the sterilization of the internal packaging of pre-filled syringes in aseptic) and in the medical sector (eg surgical kits) and in the prosthesis sector.

The benefits are immense.

The first is the ecology of the process. At the end of the process, the peroxide molecules are split into hydrogen and oxygen by means of a static catalyst and ecologically expelled into the atmosphere.

The second, linked to the first, and the lack of need for all the permits and authorizations related to the Eto (or Gamma Rays).

The third is that at this point the machine (impossible with ETO or Gamma Rays) can be inserted in the production plant and the products can be sterilized one minute after their production, with consequent reduction of costs related to external centers, immense savings of time and elimination of bottlenecks.

The fourth advantage and the overall CAPEX cost of a HyPerPure peroxide system versus an ETO, much lower in the case of HyPerPure technology which does not require preconditioning chambers, post-conditioning, burners, safety rooms for storing cylinders, etc.

The fifth advantage is the OPEX cost. The management and cost of a sterilization cycle is much lower than ETO as you can use common commercial 35% peroxide which has a much lower cost than ETO, and finally it is used in a few weights per cycle. .

The sixth advantage is the speed of the cycle: from 3 to 5 hours for HyPerPure versus an ETO cycle where, if the preconditioning and degassing phases are calculated, it goes from 24 to 48 hours … so truly a revolution.

Can this new technology be applied to all materials, including plastics?

For how we manage peroxide, we have not identified any particular critical issues. We always carry out preliminary analyzes with our partners in our laboratories to check the compatibility of the materials.

The literature, which in some cases expresses incompatibility with peroxide, tends to refer to peroxide in the liquid state, or in cases of continuous exposure: imagine an environment that is decontaminated with peroxide every day. Instead for medical instruments, which tend to be disposable, no material compatibility problems have so far been identified.

The strong environmental and industrial impact that EtO sterilization currently has, can it be converted with HyPerPure technology?

Absolutely yes.

How much it can impact as an investment cost on small and medium-sized enterprises. Can it be a sustainable cost?

As explained above. Faced with a new plant, both opex and capex costs are significantly lower for HyPerPure than for ETO.

Finally, even if a company already had an ETO system, the only savings in cycle costs (without counting safety costs, controls, authorizations) justify the investment and the transition to the new technology.

Finally, it must be said that De Lama builds plants from 400 liters to 50 cubic meters, therefore costs must also be parameterized to the production capacity. A small business will probably not need a very large plant.