In compliance with:
cGMP, FDA, GAMP, 2006/42/EC, 2014/30/UE, 2014/35/UE, PED 2014/68/UE , UNI EN 285:2016 – Sterilization: Steam sterilizers – Large sterilizers (where applicable)
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De Lama has developed an innovative process starting from the multi-annual experience in the sterilization field. Hydrogen Peroxide under deep vacuum.
The peculiarity of the use of the vacuum technology allows gas full penetration into the widest variety of packaging. Vacuum system is composed by multiple step high vacuum system to allow the most effective sterilization phase and gas removal at cycle end.
The sterilisation or decontamination cycles work in an open loop, without any consumable, and grant a very high level of repeatability.
Thermo-labile finished products in blister can be fully sterilised in the most recessed cavities.
DESIGN & CONSTRUCTION FEATURES
MAIN ADVANTAGES & FUNCTIONAL FEATURES
The process is extremely fast when compared to other sterilization processes
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.
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.
PRODUCTS STERILIZABLE WITH DLVHP/ST
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, Hydrogen 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.
For those thermolabile products, once sterilizable only through ETO (ie ethylene oxide gas) or gamma rays, today there is a new solution.
The result is to replace the demanding management of ETO (flammable, toxic and expensive to manage) with a much simpler, cheaper and eco-compatible process that can also be completely internalized in the company (unlike gamma rays, that for their criticality are managed in specialized centers outside the manufacturing company).
Another field of application where until now the ETO was the only solution.
Thanks to the deep penetration of Hydrogen Peroxide and its cold process, Sterilization through De Lama DLVHP/ST is a new solution for Prosthesis for implants of various materials and for diffrent surgical applications like: knee, ankles, elbow, jaw and more.
Prosthesis are usually sterilized inside their plastic or Tyvek packaging.
De Lama is always available to test the sterilization of every single prostheys produced in order to verify the perfect sterilization also in the most inner parts and holes for objects with a complex design and also to verify the complete material compatibility with Hydrogen Peroxide.