STERILIZER IN THE WORLD DE LAMA ISO 14001 CERTIFIED ENVIRONMENTAL SYSTEM Process & Sterilization Solutions since 1949 GMP H2O2 STERILIZERS DLVHP/ST Series Low Temperature Sterilization technology Deep Vacuum Zero Air Hydrogen Peroxide The industrial and pharmaceutical H2O2 treatment unit for terminal sterilization of thermo-labile solids, porous materials and products packaging But also a green alternative, in many cases, to traditional heat sterilization. MAIN FEATURES H2O2 vapors Exclusive De Lama Chamber with custom shape penetration by Patented H2O2 & size from 150 lts. high vacuum system HyPerGeneSys® generator up to 80 cubic meters Compliant with the current International standards SCADA Windows OS control system,

OVERVIEW De Lama has developed an innovative process starting from its many years of experience in the sterilization field: HyPerPure ® Low temperature sterilization technology with Hydrogen Peroxide under deep vacuum and zero air. HyPerPure ® Sterilization technology is a proprietary solution by De Lama operated with De Lama DLVHP/ST equipment. It’s a low-temperature sterilization process representing the real alternative to EtO (Ethylene Oxide gas) and Gamma Rays sterilization, and offering important advantages compared to these more traditional techniques. Thermo-labile finished products can...

PHARMACEUTICAL INDUSTRY APPLICATIONS PRODUCTS STERILIZABLE WITH HyPerPure ® TECHNOLOGY 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 (or they have been filled in aseptic), the legislation stipulates that even the air inside the packaging and the external surface of the syringe...

PRODUCTS STERILIZABLE WITH HyPerPure ® TECHNOLOGY Sterilization of thermosensitive medical devices such as catheters, plastic syringes, masks, etc. For those thermolabile products, once sterilizable only through EtO (i.e. Ethylene Oxide gas) or Gamma Rays, today there is a new solution: HyPerPure®. 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 inside the company (unlike gamma rays, that for their criticality are managed in specialized centers outside...

HyPerPure ® 5 BIG ADVANTAGES FOR PHARMACEUTICAL COMPANIES • HyPerPure ® is a low-temperature sterilization technique which meets at best the carbon HyPerPure ® used in conjunction with isolator removes the requirement for a Material HyPerPure ® used in conjunction with isolator can be used to sterilize also thermosensitive HyPerPure ® used in conjunction with isolator can be combined with heat type sterilization HyPerPure ® is a low-temperature sterilization technique which can be used as “terminal footprint reduction goal isolator transport parts made of POM-C derivates and single use parts...

OPTIONAL FEATURE De Lama has devolped Magnetodoor® (registered trademark and PATENT PENDING) a new sliding door concept where the door movement is achieved through magnetic coupling. This design minimizes the dirt retention areas in the bioseal and allows the access to the inner side of door. Magnetodoor® can be appliead to machine standing alone, or equipment directly coupled with isolator. In case of isolator coupling the equipment can be delivered with gloves for a direct cleaning action on the rear of the door.

The direct coupling to isolator with De Lama equipment makes 3 main options possibile: Makes accessibile whole door inner side for cleaning initial sterilization of containers before their filling under isolator (eg sterilization of drums to be filled in the next stage with powders inside isolator) Double Magnetodoor Door sliding mechanism is minimized to the essencial parts, reducing the number of components and their future possible replacement and maintenance costs FILLING LINE UNDER ISOLATOR Makes De Lama equipments now directly integrable with an isolator, eliminating all problems connected...

WHY HyPerPure® IS IT THE GREENEST STERILIZER IN THE WORLD? The process is at low temperature with no thermal energy waste as occurs in hot sterilization processes (such as, for example, with saturated steam sterilization) There are no liquid discharges towards the installation environment No water consumption Very low energy consumption Zero polluting emissions (sterilization media, Hydrogen Peroxide is released into the atmosphere in Oxygen and Water molecules) Zero risk for the health of Company operators DE LAMA S.p.A. Via Piemonte 21 27028 San Martino Siccomario PV - ITALY Best option to...