Pharmaceutical Industry
The pharmaceutical industry is all about making people better and healthier. Pioneering discoveries and meticulous research are therefore dependent on guaranteed safe production processes. This requires crystal-clear advice, precision work and the appropriate certificates. There are a number of rubber compounds that are suitable for this industry, depending on the material, hardness and temperature range. An overview of suitable rubber compounds for the pharmaceutical industry is given below.
| Rubber compound | Hardness | Approval | Temperature range |
| EPDM - 559273 | 70 Shore | FDA, EC1935/2004, USP class VI | -45°C to +150°C |
| FFKM - 6221 | 70 Shore | FDA, USP class VI | 0°C to +260°C |
| FFKM - 6230 | 70 Shore | FDA, USP class VI | 0°C to +260°C |
| VMQ - 714001 | 70 Shore | FDA, EC1935/2004, USP class VI | -60°C to +200°C |
| Teflex® FEP/silicone | 70 Shore | FDA, EC1935/2004, USP class VI | -60°C to +200°C |
EPDM - 559273
EPDM 559273 is a peroxide-cured EPDM compound suitable for hot water and steam applications. The compound complies with the FDA, European Regulation EC 1935/2004 and USP class VI.
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FFKM - 6221
Kalrez® is a brand name of Dupont®, the ISO name is FFKM. Kalrez® is a material with a chemical resistance comparable with Teflon® and rubber properties close to those of Viton®. This compound is extremely stable at high temperatures and has excellent ageing resistance. Kalrez® 6221 is white in colour and complies with FDA and USP class VI. It is suitable for use with SIP (steam-in-place) cleaning.
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FFKM - 6230
Kalrez® is a brand name of Dupont®, the ISO name is FFKM. Kalrez® is a material with a chemical resistance comparable with Teflon® and rubber properties close to those of Viton®. This compound is extremely stable at high temperatures and has excellent ageing resistance. Kalrez® 6230 is black in colour and complies with FDA and USP class VI. It is suitable for use with SIP (steam-in-place) cleaning.
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VMQ - 714001
Silicone is a material suitable for low and high temperatures, air and oxygen. Given the mechanical properties of silicone, it is advisable to use it in static applications only. The compound complies with the FDA, European Regulation EC 1935/2004 and UPS class VI. The hardness of this compound is 70 Shore A and the colour is transparent.
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Teflex® FEP/silicone
TEFLEX® FEP/silicone is a two-component material providing a very chemically resistant seal with its chemically resistant FEP casing in conjunction with an elastic silicone rubber core. It is very suitable for low temperatures and for static applications only. This material also complies with the FDA, European Regulation EC 1935/2004 and USP class VI.
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Approval and Classification
We are able to supply a wide range of rubber seals produced according to USP class VI standards. These standards are laid down by USP, an American organisation that publishes regulations for medical and pharmaceutical facilities, biotechnology and their components. The rubber material is tested for the effect of the compound and released substances on fabric. USP class VI conformity is increasingly a requirement of end-users.
Applications
Seals and technical components used in the pharmaceutical and biotechnical industry are deployed in many different applications. Typical applications include:
- Medical and diagnostic instruments
- Autoclave gaskets
- Sterilisation equipment
- Pumps
- Valves
- Filters
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