Regulation standards and organisations
FDA Contact Notification (FCN)
The Food and Drug Administration (FDA) has regulatory oversight for substances added to food, including monitoring their safe use. Section 309 of the Food and Drug Administration Modernisation Act (FDAMA) of 1997 now also establishes a Food Contact Notification (FCN) process as the primary method by which the FDA regulates substances that are classed as 'food contact substances' (FCS). A FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food, but is not an additive within the food.
During the FCN process, the sealing material and its individual constituent ingredients undergo a significant amount of research, testing and analysis to evaluate the potential for food contamination.
Successful completion of the FCN process allows the following material grades to be used in a variety of food contact applications under the Food Contact number FCN000402.
The Food and Drug Administration Modernisation Act of 1997 provides a system whereby a manufacturer or supplier of food-contact material may submit a Food Contact Notification (FCN) to FDA regarding the identity and use of the new food contact substance, together with necessary date 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 CFR § 21.177.2600.
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 CFR § 21.177.2600. The complexity and high cost of the FCN process means that it is currently restricted to a limited range of very high performance perfluorelastomer materials that are used in very demanding applications.
USP class VI standards are controlled by United States Pharmacopeia (USP), a non-governmental organisation that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies.
The standards are published in the USP-NF which is officially recognised in FDA act (21 usc § 321 et seq.).
USP class VI compounds have undergone tests to:
Some elastomers are also formulated following the European Pharmacopeia.
USP class VI was especially developed for the pharmaceutical industry.This information has been carefully prepared to help in selecting the correct elastomer or perfluorocarbon utilized in high purity sanitary hygienic seals where critical pure water, process fluids (both ambient and hot), and SIP environment exist.The intention is to consider the different uses, applications and conditions to determine the most favourable gasket material for each application. The following criteria are used in determining correct sanitary gasket materials.
- USP Pharmacopoeia Class VI-XXII Certification
- Cytotoxicity Criteria
- CFR Title 21 Section 177.1550 (PTFE)
- CFR Title 21 Section 177.2600 (rubber)
- Traceability: Lot and Batch
- Certification: Lot and Batch
- ASME-BPE Standards
- USD Standards
- 3-A Sanitary Standards
- Current Good Manufacturing Practices (CGMP)
- Manufacturer data and specifications
- Consultation with various pharmaceutical users
The gasket materials considered are Tef-Steel® (Teflon/Stainless Steel), Teflon® (PTFE), Silicone (platinum cured), Viton®, EPDM and Kalrez®.
The 3 main goals are:
- To protect products from contamination, spalling, particulates and TOCs resulting from the use of improper sanitary gasket material.
- To protect facilities from unnecessary downtime associated with sanitary gasket failure and replacement from use of improper gasket material.
- To provide a standard of consistency of sanitary gaskets selection between multiple facilities.
Most decisions driving gasket type selection are based on chemistry, temperature, exposure limits, USP, FDA qualifications, and curing methods.
Teflon®, Viton® and Kalrez® are registered trademarks from DuPont Performance Elastomers
ERIKS manufactures seals in accordance with 3-A Standard 18-03 which defines the requirements for food quality materials that must be suitable for cleaning and sanitising solutions.
All ERIKS 3-A Sanitary Standards compliant elastomers are FDA-compliant to FDA CFR § 21.177.2600 resistant to steam sterilisation, milk fat and water, acid and alkali cleaning solutions and chlorine sanitising solution.
The ERIKS elastomers meeting the 3-A Standard include fluorocarbon, silicone, EPDM and nitrile, allowing manufacturers to select the most appropriate elastomer to temperature, chemical and physical performance criteria.
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 N° 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 CFR § 21.177.2600 and also be resistant to steam sterilisation, milk fat, acid and alkali cleaning solutions and chlorine sanitising agents.
BSE (bovine spongiform encephalopathy) is a disease, which is caused by infectious proteins, so called prionics. These proteins are very resistant, it needs steam of 133°C, 3 bar and 20 minutes to destroy them. It is necessary to avoid to introduce any BSE prions into plants or food and beverage industry. Stearates, fatty acids or similar can be based on agricultural or animal production.
ERIKS has checked the standard qualities excluding the use of any animal derived ingredient in order to avoid the risk of contamination with BSE prions. These qualities are certified with the logo 'ADI free' (Animal Derived Ingredients free).