Rubber components for pharmaceutical processing and medical devices
AVK GUMMI develops, produces and sells rubber components for use in the manufacturing of medicine and care products as well as medical devices. Naturally, there are high demands on quality and know-how as well as regulatory compliance. We produce customised rubber components for a wide range of applications – from the most simple products for couplings for high precision micro components and gaskets with a thin film of PFA or other PTFE-like materials.
Why our rubber solutions are suitable for healthcare
Rubber components for contact with skin or medicine are subject to enhanced requirements as a number of factors may affect the medical product or the skin and with that the safety of the consumer.
Therefore, we have particular focus on the following factors:
- Rubber for contact with skin must not cause allergic reactions or otherwise pose any form of health risk.
Read here: How to document the suitability of rubber for contact with the consumer
- The rubber compound must not release substances that may affect the effectiveness or the shelf life of the medicine or create undesired degradation products.
- The rubber compound must be suited for the function of the process equipment. The surface of the rubber component must be easy to clean and sterilise for the sake of the product quality and consumer safety. The rubber formulation must be resistant to cleaning agents, sterilisation and of course the product itself.
Read here: Rubber production in relation to EHEDG
- The properties of the rubber material must provide optimal functioning, e.g. minimum permanent deformation, which ensures leak-tight gaskets. High tensile strength ensures a long lifetime, and low friction reduces the closing torque, e.g. in a butterfly valve. This reduces the energy consumption when operating the valve.
Which type of rubber should you choose?
This depends on the nature of the application. For instance, fluorosilicone would be a good choice for a microphone mount for a hearing aid due to the acoustic clamping characteristics of the material. In the case of a gasket for a processing plant, it must be considered if the product is soluble in water or fat, just as the cleaning system and working temperatures are important factors. Naturally, compliance is an important aspect; in which country will the component will be used, and in which markets will you launch the product?
IPR – ownership of your rubber solution
When we develop a new compound, we use this for as many products as possible. However, if we develop a compound for you and this is critical to your business, we can offer to enter into an exclusivity agreement.
The tool that we design for the production of your item is based on your product design and our unique tool design. You will always own IPR of the product design.
Transparency concerning the allocation of IPR is your guarantee that our collaboration will give you a competitive edge and secure your know-how.
The primary types of rubber in our healthcare programme are:
- Silikone og Fluorsilikone
Security of supply through advanced production
When the supply chain is challenged in a global market, you and your customers are highly dependent on your suppliers. Will you receive the products at the right time and price? And will the suppliers take responsibility for the quality of the product?
AVK GUMMI offers you security of supply in an insecure world.
We consider ourselves particularly strong within the following parts of the supply chain:
- We cooperate with large, well-reputed suppliers. Naturally, price is always an important aspect, but we must never compromise on quality, security of supply or CSR.
- We have one of the world's most advanced, fully automatised mixing plants where the raw materials are weighed and dosed with the greatest precision. This enables us to manufacture rubber compounds of a uniquely high quality and uniformity.
- With our complete pilot plant for medical products, development and validation processes are carried out in an efficient and safe manner.
- We make sure that we have the right foundation for production, including the right tooling solutions. Furthermore, we always carry out a thorough validation of each manufacturing step before release for production. This is your guarantee that you always get the agreed and expected quality.
Traceability in our production
We have the tools for quickly detecting, correcting and documenting any errors in the unlikely event of an issue with your rubber component.
We collect all relevant process data throughout the entire manufacturing process. The data is stored for 25 years. Together with date marking and material identification on the parts, this forms the backbone of our traceability. If you require further documentation for your product, we can offer batch journals, double-checking, etc.
Safety through certifications
Our certifications are your guarantee that we live up to our own high standards. We always focus on safety, quality and the environment, which means that you can fully concentrate on your product without having to spend time on supplier audits. If, however, you should to carry out an audit, you are always welcome!
At AVK GUMMI, we are convinced that focusing on quality, occupational health and the environment pays. Our quality management system is certified in accordance with ISO 9001 and IATF 16949. Validated processes, change control, handling and storing of data and all central elements of ISO 13485 are an integrated part of our quality management system for the production of healthcare products. Furthermore, we can offer you production and packaging in cleanroom facilities. Finally, naturally we comply with the requirements to GMP in accordance with EC 2023/2006.
Our production facilities outside of our healthcare and medico production facilities are also extraordinarily clean and safe and certified in accordance with ISO 45001. In 1991, as one of the first rubber manufacturers in the world, we obtained an environmental certification in accordance with ISO 14001
Reduced environmental impact
AVK GUMMI constantly sets up new targets, and our own environmental standard goes beyond that of the public authorities. This is your security that our cooperation will always give you the best possible environmental solutions tailored for the future
Finally, we think of the environmental footprint that we leave behind. Every day, we work on reducing our energy consumption and minimising the waste. For instance, we deliver the rubber waste that we cannot entirely avoid to the local CHP plant where the waste is turned into heat and electricity. Our life cycle analysis has shown us that this is the most sustainable way of handling our rubber waste.
Consumer safety in a global perspective
If your company operates in multiple markets, you know all about the challenge of complying with the different legal requirements, recommendations and standards – and the burden that comes along with the obligations of documentation. At AVK GUMMI, we produce rubber components for healthcare based on compounds that comply with USP. Depending on your product, we will have In Vitro and In Vivo tests carried out – however, most of the tests are carried out In Vivo in accordance with USP <88> Class VI.
The test procedure for rubber compounds used for medical equipment is somewhat different – these compounds are approved for each specific purpose. Together, we define the approval requirements, generate the required documentation and obtain the necessary approvals. Typically, an approval of the equipment is required. This often consists of several components from independent sub-suppliers. Therefore, normally you will be the one to submit the application, supported by our material approvals.
We send our rubber formulations and test samples to independent, accredited test institutes for testing.
This list shows a selection of the many standards fulfilled by rubber compounds from AVK GUMMI:
- USP <87>
- USP <88> Class VI
- ISO 10993-5
Product development with focus on you and your product
If you are looking for competent advice to improve your product, we are here to assist you. Often we can challenge you with new ideas that you may not have thought of. We are also happy to participate in the development of a new product right from the start – without taking over your design process.
Our focus is to transform your product requirements into concrete development parameters. This may be in the form of mechanical performance criteria, such as damping or documentation of ageing properties, to support your stability data.
With our competent advice as well as our development and production process, you and your product are in safe hands.