Industry & Applications

Pharmaceutical & Bio-analytical

Pharmaceutical & Bio-analytical

We offer a full range of sealing technology for pharmaceutical and bio-analytical industries where both mechanical and chemical properties are crucial, and hygienic sealing capability is critical. Our pharmaceutical material grades include EPDM, Nitrile, Silicone, FKM and FFKM, which have been specially developed to withstand steam-in-place (SIP) and clean-inplace (CIP) procedures within pipework and vessels. In addition, many of these materials are compliant with the requirements of the Food and Drug Administration (FDA), United States Pharmacopeia - Class VI (USP Class VI) and 3-A Sanitary Standards.

Food and Drug Administration (FDA)

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 in theory restricted to the United States, FDA regulations are commonly adopted as international control standards. Through its Codes of Federal Regulations the FDA provides 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 extractable 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. The 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. We offer an extensive range of FDA-compliant material grades that is unrivalled in the sealing industry. The range includes EPDM, nitrile (NBR), HNBR, silicone, chloroprene, fluoroelastomer (FKM) and perfluoroelastomer (FFKM). In addition, developed is an exciting new range of metal detectable elastomer compounds designed specifically to meet the stringent demands of the food processing industry. The DETECTASEAL™ range includes FDA-complaint grades with compounds available in blue, white and black. DETECTASEAL™ O-rings have been tested and proven in use at leading food manufacturing plants in the UK.

Food Contact Notification (FCN)

The Food and Drug Administration Modernisation Act of 1997 provides a system whereby a manufacturer or supplier of food-contact material may submit an FCN to the FDA regarding the identity and use of the new food contact substance, together with necessary data to demonstrate that the substance is safe for its intended use. FCN is a formal acceptance of a material by the FDA, so it is fundamentally different to self-certification to FDA CFR21.177.2600. An FCN application requires a detailed analysis of the compound, its constituents, toxicological effects and intended uses, and is much more rigorous than the requirements of CFR21.177.2600. The complexity and high cost of the FCN process means that only a limited range of very high performance perfluoroelastomer materials, that are used in critical and very demanding applications, have FCN acceptance. We offer a number of perfluoroelastomer (FFKM) grades which are FCN accepted, ranging in hardness.

USP Class VI

The United States Pharmacopeia is a US non-government organisation that promotes public health by establishing stateof-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 producing multi-purpose designs to be used in a range of different industry sectors. Standards are published by the United States Pharmacopeia in 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 tissue. We offer a range of material grades approved to USP 29, NF24, 2006 for the Biological Test for Plastics, Class VI including EPDM, Silicone, Fluoroelastomer (FKM) and Perfluoroelastomer (FFKM).

3-A Sanitary Standards Inc.

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. The elastomers we offer meeting Classes I, II and III of the 3-A Standard include Fluorocarbon (FKM), Silicone, EPDM and Nitrile, allowing manufacturers to select the most appropriate elastomer according to temperature, chemical and physical performance criteria.

Potable Water Grade Seals

In the UK, FDA-compliant materials approved for drinking water applications, must also satisfy the requirement of British Standard BS2494 (type W) for the Water Research Council in the United Kingdom. The testing regime for WRC approval is different to FDA testing, in that it requires elastomer products to be tested to ensure that they do not promote the propagation of bacteria and do not give any taint to potable water. KTW (Germany) specifies the requirements of elastomers in potable water as set out by the German Technical and Scientific Association for Gas and Water (DVGW) in the regulation “Arbeitsblatt W270”. In France, the medical control of the water intended for human consumption is controlled by l’Autorite de Controle Sanitaire (ACS). Drinking water approvals vary from country to country, although it is common for one country to use a material that has been approved under the standard of another country. Our technical team can advise on which products are suitable for drinking water applications against a number of national standards. Request a copy of our ‘Elastomers for the Food, Water and Dairy Industries’ or download it from our website.