Perlast® G74S and G75S Certificates
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Food & Drug Administration |
United States Pharmacopeia |
3-A Sanitary Standards Inc Certificate |
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The Food and Drug Administration is the US Federal Agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. Although the jurisdiction of the FDA is restricted to the United States, FDA regulations are commonly adopted as international control standards. Through its Codes of Federal Regulations the FDA promulgates a list of materials and chemicals that are approved for contact with foodstuffs. CFR 21.177.2600 describes the relevant regulations for ‘Rubber articles intended for repeated use’. This lists the ingredients, and any quantitative limits, that may be used in a rubber compounds for moulded products intended for repeated use in all stages of food manufacture, preparation and transportation. CFR21.177.2600 also specifies limits on extractible products if the elastomer is to be used in contact with aqueous or fatty foods. The regulation specifies extraction test limits in water and n-hexane. It is important to note that for an elastomer to be compliant to these requirements, then this claim must be supported with appropriate documentation.
FDA does not ‘approve’ products to CFR21.177.2600. It is for the manufacturer of the finished rubber product to demonstrate compliance. It is also important to note that whilst a component may be made from a material that is suitable for food contact; this does not mean that the part is technically suitable for its intended application. USP Class VI (United States Pharmacopeia) The United States Pharmacopia is the non-government organisation that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. Whilst this organisation is concerned with the pharmaceutical and bio-technology industries, many manufacturers of hygienic equipment will be designing multipurpose designs that may be used in a range of different industry sectors.
Standards are published in the United States Pharmocopia and the National Formulary (USP -NF). Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractables, on animal tissue. Formed by the US Food and dairy industry, 3-A Sanitary Standards Inc. defines specifications and best practice for the design, manufacture, installation and use of hygienic equipment. As with FDA, the 3-A standards are adopted on a worldwide basis. Standard no 18-03, ‘3-A Sanitary Standard for multiple-use rubber and rubber-like materials used in product contact surfaces in dairy equipment’ describes requirements for food quality materials that must also be suitable for cleaning and sanitising.
To comply with the requirements of the Standard, the elastomer materials must comply with FDA CFR21.177.2600 and also be resistant to steam sterilisation, milk fat, acid and alkali cleaning solutions and chlorine sanitising agents. |
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