GEA Procomac receives FDA Letter of Non-Objection |
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Hudson, April 2nd 2008 GEA Procomac receives FDA Letter of Non-Objection for a new Aseptic Filling TechnologyGEA Procomac, a GEA Group company specialized in aseptic filling technology for PET containers, has received a letter of non-objection (LNO) from the United States Food & Drug Administration (FDA) for aseptic filling systems for low acid shelf-stable products.
The non-objection letter was granted after FDA review of a master file submission based on Procomac’s aseptic line installation at Aseptic Solutions Inc., a company based in Corona, CA. The National Food Laboratory (The NFL) served as Procomac’s Process Authority for the master filing. Procomac FDA-compliant aseptic filling technology for PET uses peracetic acid in liquid form to sterilize containers. Full recovery of sterilizing solution and rinsing water is built in the system to reduce consumption of chemicals. Procomac has pioneered a number of aseptic technologies in the past ten years, including the use of a microbiological isolator technology instead of the traditional clean room environment for aseptic filling lines. Procomac currently has installed 86 aseptic filling lines; 30 of them are capable of running low acid products and 6 of these lines have been built to FDA standards in the United States. Paolo Pagliarini, R&D Director of GEA Procomac, is very pleased of the outcome of an outstanding re-search activity: “during the FDA filing process we upgraded our aseptic technology in a number of aspects. We can now offer the safest aseptic technology available in compliance with the FDA”. Massimo Beretta, Managing Director of GEA Procomac, points out the market possibilities of the FDA-compliant aseptic technology: “a wide range of low acid products, including milk-based drinks and nutraceutical products, can now rely on a risk-free aseptic technology”. Pierpaolo Mattana, Procomac Department Manager North America of GEA Niro confirms the significant investment the company is making in North America and the positive reception from the market: “by the end of 2008 we will have 7 new high speed aseptic filling systems in production in the United States”. GEA Procomac is an Italian company based near Parma in northern Italy. GEA Procomac is part of Process Engineering Segment of GEA Group. Procomac specializes in design, construction and commissioning of complete aseptic filling lines for juices, tea, sport drinks, dairy products. Procomac turnover for 2007 is in excess of 130 million € with a workforce of more than 500 people. GEA Niro is a full-service engineering company offering systems and solutions for liquid and powder processing based in Hudson WI. GEA Niro is responsible for sales, service, and local project support and procurement for GEA Procomac in the United States. Niro Inc. is especially known for innovative processing systems for drying, evaporation, distillation, filtration, liquid processing, containment, cleaning (CIP), fermentation as well as process integration and automation. GEA Niro is also a GEA Process Engineering Company. In the US, the management expects tremendous synergies between GEA Procomac and Niro Inc.'s GEA Liquid Processing group. The GEA Group, headquartered in Bochum, Germany, is a globally successful technology group with more than 250 companies in 50 countries. The company focuses on specialty mechanical engineering – especially process engineering and equipment. GEA Group technologies are applied in the food, chemical and petrochemical industries, the energy sector, air treatment and shipbuilding as well as the pharmaceutical and cosmetic industries. For further information: Carlo Ferrari, Marketing Manager GEA Procomac Spa
GEA Procomac Spa
Pierpaolo Mattana
GEA Process Engineering Inc. Other useful links:
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