During last month’s ACHEMA 2009 in Frankfurt Germany, Getinge Infection Control introduced three new sterilization products. This Swedish manufacturer was one of over a dozen sterilizer companies that took advantage of this world class event to show off their finest products. Getinge’s offerings included the brand new GEV series, the STERBOX E-Beam system, and the ISOTEST.

Getinge is a publicly traded company that is now more than 100 years old. Today, they continue to provide quality state of the art infection control products for the healthcare, research, and pharmaceutical/medical devices industries.  The exhibition at ACHEMA this year is an example of their commitment to innovative technological progress in the sterilization field.

GEV

The GEV ventilation sterilizer is used for the manufacturing of injectable products.  Traditional steam sterilizers remove air before sterilization.  In contrast, the GEV keeps air inside the chamber so that counter pressure can be created during processing.  This is particularly useful with applications involving liquid pharmaceutical products, such as filled syringes and vials.  The drying and cooling cycles are gentle and thorough.

This equipment can be used for a lot more than just vaccine production.  It is one of the only reliable and cost effective means of processing certain blister packed products including contact lenses. The GEV can also provide significant cost savings by replacing EtO or radiation sterilization in the manufacture of medical devices such as dialysis filters.

STERBOX E-Beam

The STERBOX is an in-line sterilization tunnel.  The continuous nature of this room temperature unit makes it an excellent turnkey solution for the handling of small volume parenterals and medical devices.  This medium energy electron beam accelerator provides complete decontamination for products being transferred into a Class A environment.  It can also be used for terminal sterilization of pre-packed medical devices or pharmaceuticals.

This machine is a stand-alone unit that can be customized to handle all the necessary ancillary equipment in a compact area.  The quick moving process provided by the STERBOX makes it ideal for assembly line applications. The electron beam leaves no residue.  It uses 5kW beam power. This device was developed in concert with Getinge’s partner company, Compliant Logistics.

ISOTEST

The ISOTEST is a new isolator that provides quick and efficient sterility testing.  It includes an integrated hydrogen peroxide vapor (HPV) decontamination system.  The rapid HPV sanitization of the input-lock chamber does not interfere with the growth of bacteria during bacteriostasis or fungistasis tests.  Nor does it create or allow any adverse effects on any positive samples.

It is a face to face work station where one or two operators use sleeves and ready-to-fit sterile gloves to perform the tests.  A Millipore Equinox Steritest pump and DPTE® door for wastes is provided at each work station.  The second station can be configured for direct inoculation testing.

Waste is collected with a chemical protection system for both the unit’s environment and the microbial sample and placed into a special DPTE®-Disposbag.  DPTE® sealed sleeves protect the work space and the Steritest canisters from contamination during the transfer to the incubator.

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