DLVHP/ST, the new Vacuum Hydrogen Peroxide sterilizer, and DLVHP/DE, a next generation pass-box decontamination unit, with impressive advantages for the pharmaceutical industry
Welcome in the future of sterilization with new DE LAMA DLVHP/ST, the new Vacuum Hydrogen Peroxide Sterilizer ! 10 years of study, to develop a machine that is able to change many rules of the game in the field of sterilization.
De Lama SpA has just launched its new jewel on the market: the DLVHP/ST, a vacuum hydrogen peroxide sterilizer, that includes really important advantages.
The new frontier has been reached bringing the use of hydrogen peroxide (H2O2), currently used in decontamination processes (pass-box equipments for the degermation of surfaces), towards a further step: that of the real sterilization through processes in rarefied atmosphere. The new technology, fully validable and repeatable, allows to create fast, safe, low temperature processes with exceptional cost savings.
APPLICATION SECTORS OF DLVHP/ST
The Application Sectors, where the technology is designed to supplant the previous ones, are the following:
A)Terminal sterilization of packaging, even outside a classified area.
The process of packaging products such as syringes already sterilized, can now be done by totally eliminating the use of the very expensive Class A (or B) clean room where it was necessary to realize the packaging of the products. Although the contents of the syringe have been previously sterilized, the legislation stipulates that even the air inside the packaging and the external surface of the syringe must be sterile. Until now there was no other solution than to realize the packaging operations inside a classified and aseptic area. Today all this can be avoided. With the autoclave proposed by De Lama, peroxide, by means of a strong vacuum, is able to penetrate the packaging and to penetrate surfaces such as Tyvek, thus sterilizing the environment inside the package and the external surface of the product.
Tyvek (or other) specific package, once extracted by autoclave, even if the operation is realized in a non-classified area, preserves the sterile environment inside packaging created by sterilization process through Hydrogen peroxide made with DLVHP/ST.
To carry out this sterilization it is sufficient to insert the packages in the chamber and start the cycle. All of this can occur, we repeat the concept, also in a lower classification environment, thus avoiding the costs of environments classified as high-level aseptic.
B) Sterilization of thermosensitive medical devices such as catheters, plastic syringes, masks, etc.
For those thermolabile products, once sterilizable only through ETO (i.e. the Ethylene Oxide gas) or gamma rays, today there is a new solution. The result is to replace the demanding management of the ETO (flammable gas, toxic and expensive to manage) with a much simpler, cheaper and eco-compatible process.
C) Heat-sensitive Surgical Kits.
Another field of application where until now the ETO was the only solution.
ADVANTAGES OF DLVHP/ST, VACUUM HYDROGEN PEROXIDE STERILIZER
Wide and very significant advantages of Hydrogen Peroxide sterilization under vacuum:
1) No more need of the clean room for packaging sterilization
As we have already explained, the DLVHP / ST eliminates the need for clean rooms (which have very important plant, space and management costs), avoiding the need to perform operations in the classified area A or B and is a valid alternative to the use of ETO.
Beyond that there are other advantages to consider.
2) Time savings.
The process is extremely fast when compared to other sterilization processes.
3) Savings on filter elements and ventilation systems.
The final elimination of peroxide in the room does not provide for the impact on HVAC filters: in fact,
there are no air flows for the degassing of the machine that impact on the company’s ventilation systems.
4) Savings on maintenance costs.
The DLVHP / ST is also equipped with a catalyst for the elimination of hydrogen peroxide residues which does not require the need for consumables and, therefore, maintenance costs for the replacement of components.
DLVHP/DE VACUMM HYDROGEN PEROXIDE DECONTAMINATION UNIT (PASS-BOX USE)
Based on the design of the new sterilizer, the Pass-box version with Hydrogen Peroxide named DLVHP / DE has been created.
Pass-boxes are those equipments that makes possibile to ‘pass’ objects from an area with higher contamination grade, to a better classified area by decontaminating their surface.
Pass-box equipment creates through its chamber a passage from area to area. Objects are put inside the camera from the lower classification area (dirtier area), then decontaminated inside the Passbox, and after decontamination process are extracted from the chamber of pass-box towards the better classified
area (cleaner area- eg. from C area TO B area).
De Lama DLVHP/DE Passbox is revolutionary.
The machine is able to offer itself as the most advanced pass-box in the world because, compared to the classic pass-boxes, it presents a very fast process with savings of up to 70% (from 3 hours to 1 hour on average). And like its eldest sister, DLVHP / ST has no impact on ventilation systems and is equipped with a catalyst that does not use consumables. Such advantages cannot be ignored by the pharmaceutical industry, always looking for repeatable and validable and faster, ecological and economic processes.