ATS Automation Tooling Systems has announced it is showcasing a prototype of its new, ultra-clean, aseptic robot at INTERPHEX, the pharmaceutical industry's premier annual equipment exposition opening tomorrow in New York City.
The new robot technology - Vaporous Hydrogen Peroxide (VHP)-compatible robotics (VHP Robot) - is believed to be the first automated robotic solution capable of withstanding the harsh sterilization treatment required by aseptic process environments. "The pharmaceutical industry needs VHP compatible robotics and we've been working on developing this innovative automation technology over the past year," said Klaus Woerner, ATS President and Chief Executive Officer, "we expect our VHP robot development will be completed and FDA validated by the end of calendar 2004. We expect our first sale of the VHP robot will be to a global pharmaceutical customer who is already an ATS customer.
They are keenly interested in the technology and in fact they have already provided real life applications requirements to assist us during the development stages.
As such, the first application for our VHP robot is expected to be in automated batch sterility testing, a slow and laborious process that is nevertheless critical in releasing every drug production lot to market." Mr.
Woerner said ATS is also targeting other applications for VHP robotics such as cell culture and harvesting for liquid biologic production, production of certain clinical trials materials, in-line high volume check- weigh operations as well as potent and toxic compound handling.
Aseptic manufacturing is a large and rapidly growing area in pharmaceuticals, with growth being driven in part by the emergence of biotechnologically derived drugs, most of which must be aseptically produced.
For example, global vaccines sales alone are projected to grow 12% compounded annually over the next five years from their current level of USD $9.8 billion. The aseptic biotech drug market extends well beyond this level.
The Need for Automation in Aseptic Processes Critical aseptic processes must undergo frequent sterilization, usually with aggressive chemicals such as vaporous hydrogen peroxide (VHP) or high temperature VHP and steam. Many aseptic processes in isolated pharmaceutical production environments are entirely manual, requiring the use of glove ports.
Manual processes in such environments are notorious for their low productivity, difficult worker ergonomics, and degradation of the ultra-clean isolator environment through leaks in gloves or glove port seals. VHP- compatible robotics will reduce costs and increase throughput by allowing many of these manufacturing processes to become fully automated. "Because of the complexity involved in production, the pharmaceutical sector lags far behind other industries in terms of manufacturing productivity," said Mr. Woerner. "Our objective is to change this by working with pharmaceutical customers to solve their specialized needs.
By doing this successfully, ATS aims to become a prime supplier not only of specialized aseptic automation, but also the manufacturing solutions partner of choice for the industry's growing automation requirements."