07/08
PETplanet

The non-objection letter was granted after an FDA review of the 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-file filing.
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 FDA-compliant aseptic filling technology for PET uses peracetic acid in liquid form to sterilise containers. Full recovery of sterilising solution and rinsing water is built in the system to reduce consumption of chemicals.
There is currently a total of 86 aseptic filling lines installed by the company, of which 30 are capable of running low acid products and 6 of these have been built to FDA standards in the USA.
Paolo Pagllarini, R&D Director of GEA Procomac, is very pleased with the outcome of the company's research activity: «During the FDA submission process we upgraded our aseptic technology in a number of aspects. We believe that 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 technoiogy: «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 Inc., 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 Division 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 Inc. is a full-service engineering company offering systems and solutions for liquid and powder processing based in Hudson, WI. GEA Niro Inc. 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 Inc. 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.

The line at Aseptic Solutions

Procomac first low acid beverage filling line In the USA was installed at Aseptic Solutions (formerly Flavours, Inc.) in Corona, CA. Aseptic Solutions USA, LLC, is an R&D company working in the field of aseptically filled beverages. The company develops aseptically filled drinks from recipe to laboratory filling tests and up to the production of small batches for market tests purposes prior to large-scale commercial production.
The new Procomac line runs at up to 27,000 bph with different formats, from 6 to 32 fl. oz. for bottles in PET and HOPE. The synchronised sterilizing/rinsing/filling block has low acid filling capability (for example milk-based drinks). Container sterilisation is performed by a Gripstar GX 135 rotary steriliser with electronic control of treatment times. Bottle rinsing is performed by a Gripstar GX 90 rotary rinser. The volumetric electronic filler is a Fillstar Fx 70 with induction tunnel for the welding of an aluminum foil onto the bottle neck as a guarantee of the integrity of the filled product.
An important feature of the line is the integrated syrup room with a Unisolv BMP ingredients dosing system, designed to handle a wide range of solid, liquid and powdered ingredients. The line is completed by empty and full bottle conveyors, pack conveyors and the microbiological isolator for the filling block. In the USA Procomac is a Division of Niro Inc. and so offers a high level of sales and after-sales support including parts, line upgrades and operator training.

Effect of LNO on GEA’s client base
The recently received LNO can facilitate the adoption of Procomac aseptic technology in the USA. Currently a number of companies are evaluating the possibility of switching to cold aseptic filling in order to produce low acid beverages such as milk with tea, milk with coffee and other milk drinks, and to be able to distribute them at ambient temperature. This will eliminate the distribution costs incurred in the cold supply chain.
In addition these aseptically filled beverages will have a longer shelf life compared to their ultra-clean filled counterparts (typically 3 to 6 months as against 45 to 60 days).

FDA compliat aseptic filling
Bottled products include:

• Fruit Juices
• Sport drinks
• Still sensitive drinks
• Milk-based drinks
• UHT milk
• Iced tea and infusions
• Nutrlceutical products

Procomac has developed a cutting-edge aseptic filling technology for sensitive beverage filling under aseptic conditions. Procomac pioneered the use of the microbiological isolator technology instead of a clean room, and has perfected a wet peroxide sterilization technology that offers outstanding performances for high acid and low acid products. Procomac aseptic technology is used in more than 86 line Installations worldwide.

Benefits of Procomac aseptic technology

• Lightweight PET bottles instead of expensive heat set PET bottles
• Freedom to use any PET bottle shapes to obtain appealing products
• Shelf-stable aseptic products eliminate cold supply chain distribution costs
• Procomac aseptic technology is compliant with FDA regulations
• Very high product quality
• Outstanding process safety

Key Features of Procomac aseptic technology:

• Wet Peracetic acid is used for container sterilization
• Microbiological isolator for environment control and easy management of the line
• Integrated process units for utilities management
• Reduced consumption using recovery systems for water and chemicals
• Full traceability, process control of the whole line from a single control panel.