Certificates, approvals and standards for sealing technology

There are numerous regulations, standards and requirements for almost all areas and industries that must be complied with and are sometimes confirmed by certifications. These regulations also exist in the field of sealing technology.

Depending on the area of application, seals must meet different requirements in order to be classified as reliable. The guidelines are particularly strict in sensitive areas such as food and drinking water production as well as the pharmaceutical and medical industries. In this article, we explain why strict regulations are so important and what the various standards mean for consumers and manufacturers.

 

At the latest when people ingest and consume products or come into contact with certain substances or medical products for health reasons, this becomes a particularly sensitive area. This includes all sectors relating to food, drinking water and the medical and pharmaceutical industries. Even if the regulations are often similar, there are different requirements, certifications and standards in each sector depending on the use and areas of application of the respective products. This also includes all materials and components such as seals that are used in these areas.

For this reason, traceability is particularly important in these sectors. It should be guaranteed at all levels to make it easier to carry out inspections, recall defective products or establish liability. It should be possible at all times to identify all companies and enterprises from which materials or items were either purchased or supplied.

We define food as anything that is intended for human consumption in order to nourish the body. For this reason, it goes without saying that food must be free from toxins, impurities or other substances that are harmful to humans.

There are countless regulations and guidelines on hygiene when handling food in production, processing, storage or transportation. This also includes all cleaning agents, lubricants and care products that are used to maintain or clean machines and come into contact with food.

However, the regulations are even more far-reaching: adhesives, materials used and components installed in machines intended for the food industry must also have corresponding certificates. This also applies to seals such as O-rings or hoses for transporting liquids.

This ensures that all materials, substances and components used are harmless and do not release any undesirable or hazardous substances into the food - and therefore people.

 

Water is the most important commodity on our planet: Life is not possible without water. Drinking water is therefore subject to strict regulations and approvals worldwide, which are intended to make it safe for human consumption.

However, water is not only used as drinking water, but also as so-called service or industrial water, as we know it in sanitary or heating systems, in energy generation or industrial production.

Irrespective of the regulations for foodstuffs, drinking and industrial water are subject to their own standards, regulations and certifications. This also applies to sealing materials for applications in drinking and industrial water systems. This ensures that the materials used are toxicologically harmless and largely extrusion-free. They are used in a wide variety of applications, ranging from water extraction, treatment and transportation to extraction by the end consumer.

In addition to being harmless, seals must also fulfill many other functions in connection with drinking and process water. Not only do they have to seal reliably and have a long service life, they also have to be wear-resistant, low-friction and resistant to calcification and deposits.

 

Materials and seals in the medical and pharmaceutical industry require high mechanical strength and chemical resistance. They not only have to withstand active pharmaceutical ingredients, but also aggressive cleaning processes and disinfectants. In addition, they must be reliable and must not cause any interactions. It must also be ensured that no substances migrate from the sealing material.

Due to the particularly high requirements, sealing materials are often specially developed for this area.

As this area also involves close contact with people and their health, there are a large number of standards and regulations that relate to the manufacture of medical work utensils and medicines or regulate the requirements and regulations of the materials used.

Even if it may not seem so at first glance, the use of seals in the medical and pharmaceutical industry is diverse. For example, they are used to seal metered dose inhalers, as stoppers or as seals for ampoule caps.

 

With the many different standards, certifications, approvals and authorizations, especially in the sensitive areas of the food and pharmaceutical industries, it's easy to lose track. Added to this are the different demands and requirements of the various countries, which are subject to their own rules.

Below we have summarized some of the best-known approvals and clearances from these areas:

 

In the food industry, the requirements are usually more stringent than in other sectors, as contaminants in food can cause serious damage.

 

FDA

The FDA (Food and Drug Administration) is the US authority for food and drug control, which reports to the US Department of Health and Human Services. The FDA monitors all goods marketed in the USA, including imports. This is why the guidelines and regulations are also important for German retailers - not every product approved in Germany or the EU automatically meets FDA conformity. Deliveries to the USA always require an FDA certificate, which is issued after the product manufacture has been demonstrated.

The aim of the FDA is to prevent disasters caused by contaminated or contaminating food by imposing strict requirements. FDA conformity requires materials that have a long shelf life and do not release any substances into food.

Elastomers and plastic products that come into contact with food, such as seals, hoses and piping, packaging or production machinery, also fall within the scope of food monitoring.

 

NSF

The NSF (National Sanitation Foundation) is a non-profit organization that promotes health safety and environmental protection worldwide. They test and validate the design, performance, construction and material safety of products.

The NSF mark stands for thorough and trustworthy product testing by independent certification organizations and is valued by manufacturers and regulatory authorities worldwide.

In the food industry, in addition to food testing and food safety certification, NSF also provides product certification for household products and appliances.

 

3-A Sanitary

3-A Sanitary Standards is an American organization that sets standards and guidelines for facilities and equipment used in the production, processing or packaging of dairy and food products. The standards are established in cooperation with local and national health authorities.

Its main objective is to ensure that edible products are free from contamination and that the relevant machinery is easy to clean.

Like the FDA requirements, the 3-A Sanitary Standards are recognized worldwide.

 

(EC) No. 1935/2004

Regulation (EC) No. 1935/2004 specifies the requirements for all materials and articles that come into direct or indirect contact with food. This is to ensure that no components are released into food that could cause a change in composition, adverse health effects or other adverse effects.

The regulation also prohibits the labeling, advertising or presentation of materials and articles that could mislead the consumer.

 

Almost all countries around the world have their own drinking water regulations and associated tests and lists of approved ingredients. These are often supplemented by physical and microbiological tests.

 

WRAS

The institution WRAS (Water Regulations Advisory Scheme) is responsible for monitoring British standards in the water industry in the UK. In addition to ensuring water quality, its objectives also include reducing water wastage.

The WRAS tests products for water fittings, sanitary systems, pipes, washing machines, dishwashers, water dispensers and much more. For example, the transfer of odor or taste to the water and whether substances or toxic metals are released into the water that are harmful to human health are tested. Tests are also carried out to determine whether the appearance of the water (e.g. turbidity) could change. It is also important to ensure that the growth of microorganisms is not promoted.

 

NSF

As already mentioned in the area of food, the NSF is committed to the safety of health and environmental protection. This also includes drinking and process water. The NSF's requirements are often more stringent than those of German or EU legislation, for example.

In the water industry, the NSF offers comprehensive water programs to ensure the quality and safety of products in this area. The range includes testing and certification of products for beverages and ice, pools, sanitary areas, water systems and supplies and plastics used in these areas.

 

KTW and ELL

The well-known KTW guideline has now been replaced by the ELL (Elastomer Guideline) of the European standard. This primarily relates to materials used in the drinking water sector. The guideline is used for the hygienic assessment of elastomers in contact with drinking water.

It also regulates the substances that may be used and which approvals are required. It also specifies the test methods and limit values (maximum test values).

 

DVGW

The DVGW (German Technical and Scientific Association for Gas and Water) is the largest industry certifier in the German gas and water industry. The association is primarily responsible for the national technical regulations to ensure the safety and reliability of gas and water supply in Germany. The DVGW is also involved in the creation of DIN, EN and ISO standards. The body of regulations comprises around 600 rules and standards.

The DVGW certificate is generally held in high regard and guarantees durability and user-friendliness. As with the WRAS, the DVGW checks that no undesirable substances are released into the water, as well as the general suitability in connection with drinking water. Seals are tested to ensure that they retain their tightness even under high loads.

 

A variety of plastics such as elastomers or thermoplastics are used in medical technology, whether as production or coating materials, in hoses or in the form of seals or O-rings.

Biocompatibility plays a particularly important role in the medical and pharmaceutical industries. This means that the material used must be compatible with the human organism and must not cause any adverse effects, such as the release of toxic substances.

According to the European Medical Device Directive MDD 93/42 EEC, a biological assessment is always necessary if there is direct contact between the material or product and the human body.

Cleanroom solutions

High standards of hygiene and cleanliness are placed on medical products in particular. A high level of cleanliness is achieved, among other things, by manufacturing under clean room conditions. A cleanroom has a particularly low-particle environment.

Seals may also need to be manufactured under cleanroom conditions in order to meet the requirements.

 

FDA

The FDA is not only responsible for food, but also for all approved medicines in the USA. Drugs and medical devices may only be produced by pharmaceutical manufacturers that comply with FDA regulations and have been tested by the FDA.

The FDA sees its task as protecting public health in the USA. In this context, it monitors the safety and efficacy of human and veterinary medicines, medical devices and biological products. This applies regardless of whether the products are manufactured in the USA or imported.

 

USP

The USP (United States Pharmacopeia) is the official pharmacopoeia of the USA. It divides plastics used in medical and pharmaceutical technology into six classes of biocompatibility. This does not only apply to medicines intended for ingestion via the gastrointestinal tract, but also to applications such as materials and active ingredients that must be compatible with human blood.

The primary goal of the USP organization is to maintain and improve human health. The strict guidelines for the manufacture of medicines and medical products are intended to guarantee the quality and purity of the substances used and thus increase the safety of patients and consumers. Both manufacturers and regulatory authorities are guided by the USP standards.

In addition to the correct identity of the drug substance, the active ingredient strength, quality, purity and composition are tested. Various tests are carried out on plastics for use in medical products to determine their biological reactivity in living organisms.

Depending on the application, the plastics are divided into the various USP classes. A product with skin contact, for example, falls under Class I, while a product that comes into contact with the bloodstream is classified as Class VI.

 

Especially when it comes to food, drinking water, medicines and medical products, purity and good compatibility for humans are absolutely essential to ensure that the products do not endanger our health.

For this reason, there are a large number of different standards, certificates and regulations for each area, which are intended to guarantee the protection of our health. Naturally, this also applies to the field of sealing technology, whose most important approvals we have presented.

As a result, not only can we as consumers be sure that the products will not harm us, but industry and manufacturers can also rest assured. The required framework parameters are already known in advance. This makes it easier to adapt and simplify processes and to plan and organize workflows.