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POSITION STATEMENT Nutricia Procedures and Controls to Minimize the Risk of Microbiological Contamination of Powdered Infant Formula Products (Neocate and Analog range) (Rockville, MD, August 2003) - Powdered infant formula products have been safely consumed by infants for many decades. The manufacturing processes employed are strictly controlled and comply with the accepted principles of Good Manufacturing Practice. However, with currently available processes and technology it is not possible to produce commercially sterile powdered infant formulas. There is a potential risk of contamination of powdered formulas with opportunistic pathogens, the most recent one of concern being Enterobacter sakazakii. Many opportunistic pathogens are ubiquitous and can be present in any type of environment. The key to minimizing the risk of contamination of feeds throughout their manufacturing, handling and storage is good hygienic practice. Nutricia employs very strict controls on microbiological contamination of manufacturing plant and processing equipment. We also carry out frequent and extensive microbiological testing of final packed product prior to commercial release. This combination of rigorous environmental monitoring and extensive final product testing means that, although not sterile, the risk of microbiological contamination of Nutricia powdered infant formula products is minimal. Environmental Controls Nutricia has developed a rigorous HACCP (Hazard Analysis and Critical Control Point) system to identify all chemical, physical and microbiological hazards at all points in the manufacturing process. Extensive HACCP studies have been conducted to identify any "at risk" areas of the manufacturing plant that come into contact with powdered product and require regular monitoring for the presence of unexpected micro-organisms (Coliforms/Enterobacteriacae, Salmonella, Listeria, Bacillus cereus and Pseudomonas areuginosa). Regular microbiological testing is carried out on air samples, water samples, mixing and packing equipment, extraction units and manufacturing personnel. Environmental samples are tested our microbiological facilities on a daily basis. All results are reported immediately and action taken where necessary to identify the source and cause of contamination and to screen all product that may have come into contact with that source. Cleaning of all manufacturing equipment coming into contact with infant formula is documented. All cleaned equipment is routinely screened for any microbiological contamination prior to use. Final Product Testing All batches of product, in its final packed form, are tested rigorously for the presence of known or opportunistic pathogens prior to release for commercial use, The nature of Nutricia products and our manufacturing process means that many small batches of product are manufactured daily. Each batch is subjected to rigorous end product microbiological testing. As a result multiple tests are run on a daily basis so that any microbiological contamination of products from the manufacturing environment will be rapidly detected and its source identified. Nutricia is confident that the microbiological controls applied to the manufacture and release of our powdered infant formula products will minimize the risk of contamination with E. sakazakii and other opportunistic pathogens. However it is important to recognize that powdered infant formula products are not sterile and must be made up strictly in accordance with the manufacturer's instructions. Good hygienic practice must be employed in the handling, storage and feeding of infant formulas at all times. For further information contact: |
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