State-of-the-art solutions with hydrogen peroxide
Article-interview taken from the October 2019 issue of NCF – Pharmaceutical Chemical News
Specializing in contamination control services, Amira has developed a customized hydrogen peroxide generator for De Lama, who has been dealing with sterilization systems for the pharmaceutical industry for over 70 years.
Thus two highly innovative equipment was born: DLVHP / DE and DLVHP / ST
“On the basis of a long and consolidated business relationship – explains Andrea Muggiasca, technical director of De Lama – we have identified Amira as the right partner that could build a fully customized hydrogen peroxide generator to be applied to two new types of equipment that today complete our portfolio. These are two cutting-edge solutions: the new vacuum hydrogen peroxide decontamination units, called DLVHP / DE, and the new equipment for the actual sterilization with high-pressure vacuum hydrogen peroxide, the DLVHP / ST ».
The innovative process that distinguishes Amira also includes the development of specific H2O2 generators (patent-pending) that can be integrated by manufacturing companies into more complex solutions.
«The R&D team of Amira – continues Muggiasca – based on needs and technical specifications defined by us has created a model of H2O2 generator that can be fully integrated into our new equipment, which they are able to offer
significant advantages for the end user in terms of effectiveness, distribution and repeatability of biodecontamination cycles “.
DLVHP/DE, conceived as an autoclave
The DLVHP / DE pass-boxes, the result of the collaboration between De Lama and Amira, bring an innovative product to the market, in particular for the advantages it introduces with respect to previous generations. The innovation of these new pass-boxes lies in their construction, conceived as an autoclave and therefore able to withstand very high vacuum and pressure tests. Another unique feature is the use of vacuum, which allows, thanks in particular to the degassing application, a greater speed of the process which, in the presence of porous materials, becomes up to four times faster than a pass traditional hydrogen peroxide box. Finally, the pass-box has no impact on corporate HVAC systems as it does not use air streams for degassing and does not even need consumables: this eliminates the costs of spare parts and maintenance. In the absence of connection to the HVAC the new DLVHP / DE pass-box allows it to be installed even when the production plant has already been designed, or even operational, without any structural impact on the plant: for many companies an option, first , unthinkable.
Total sterilization with DLVHP / ST
The DLVHP / ST, the new De Lama hydrogen peroxide sterilizer equipped with a generator designed and manufactured by Amira, ensures the level of sterility required by pharmaceutical standards (Log-6). These are the same levels obtained through a classic saturated steam (or dry heat) sterilization process and it is important to note that this sterility is achieved in all points of the product and not only in the superficial ones. This means that sterilization is also achieved in recessed cavities of objects with complex geometries, through the application of a high vacuum.
The advantage of this process is a “low temperature” treatment, similar to that of the ETO but without the criticality of an element that is difficult to manage, such as ethylene oxide, (with high toxicity and explosiveness) subject to stringent and difficult regulations to think used inside a production plant that is not a specialized external sterilization center.
Hydrogen peroxide sterilization, being at “low temperature”, is therefore absolutely ideal for those products that fear high temperatures, such as medical devices, surgical kits or for sterilizing the interior of packaging containing pre-filled syringes ( for example plastic blisters with a side sealed in tyvek). But generally it also lends itself very well to the sterilization of all the products where gamma rays came into play. We are talking about plastic packaging that can be used in pharmaceuticals but also in the food sector, and implant prosthetics, two products traditionally sterilized by irradiation.
«Thanks to the collaboration with Amira – comments Muggiasca – we are today present on the market with new solutions that are being proposed as the clean, effective alternative, finally able to open the doors to a total internalisation of the entire production process within the company, including also the sterilization phase (and eliminating the passage of external sterilization through the so-called sterilization centers).
The consultative approach, the attention to the client and the proven experience in the field of biodecontamination are among the features of Amira that have made collaboration fruitful and constructive “.