Sterilisers Equipment for the Pharmaceutical Industry
Ten years of study, to develop a machine that is able to change many rules of the game in the field of sterilisation. De Lama has recently launched its new jewel on the market: the DLVHP/ST, a vacuum hydrogen peroxide steriliser that includes important advantages.
The new frontier has been reached bringing the use of hydrogen peroxide (H2O2), that is currently used in decontamination processes (pass-box equipment for the degermation of surfaces), towards a further step: that of the real sterilisation through processes in rarefied atmosphere. The new technology, fully validable and repeatable, allows to create fast, safe, low temperature processes with exceptional cost savings, claims the firm.
Application Sectors of DLVHP/ST
- Terminal sterilisation of packaging, even outside a classified area
The process of packaging products such as syringes already sterilised, can now be done by totally eliminating the use of the expensive Class A (or B) clean room where it was necessary to realise the packaging of the products. Although the contents of the syringe have been previously sterilised, 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 realise 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 into the packaging and also penetrate onto surfaces such as Tyvek, thus sterilising the environment inside the package and the external surface of the product, states the firm.
The Tyvek (or other) specific packages, once extracted by autoclave, even if the operation is realised in a non-classified area, preserves the sterile environment inside the packaging that is created by the sterilisation process through the hydrogen peroxide which is assisted with the DLVHP/ST.
According to the company, to carry out this sterilisation it is sufficient to insert the packages in the chamber and start the cycle. All of this can also occur in a lower classification environment, thus avoiding the costs of environments classified as high-level aseptic.
- Sterilisation of thermosensitive medical devices such as catheters, plastic syringes, masks, etc.
For those thermolabile products, once sterilisable 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, mentions the firm.
- Heat-sensitive Surgical Kits
Another field of application is the heat-sensitive surgical kit where until now ETO was the only solution.
Advantages of DLVHP/ST, Vacuum Hydrogen Peroxide Steriliser
According to the firm, there are significant advantages of hydrogen peroxide sterilisation under vacuum:
- No more need of the clean room for packaging sterilisation
As we have already explained, the DLVHP / ST eliminates the need for clean rooms, 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.
- Time saving
The process is extremely fast when compared to other sterilisation processes.
- Savings on filter elements and ventilation systems
The final elimination of peroxide in the room does not provide an impact on HVAC filters: in fact, there are no air flows for the degassing of the machine that impact the company’s ventilation systems.
- 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 steriliser, the Pass-box version with hydrogen peroxide named DLVHP / DE has been created. Pass-boxes are those equipment that make possible to ‘pass’ objects from an area with a 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, adds the firm. Objects are put inside the camera from the lower classification area (dirtier area), then decontaminated inside the Passbox, and after the decontamination process are extracted from the chamber of pass-box towards the better classified area (cleaner area- eg. from C area TO B area).
The 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), claims the company. And like its eldest sister, DLVHP / ST has no impact on ventilation systems and is equipped with a catalyst that does not use consumables.