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Posted on Feb 22, 2017 in Business Tips

Pharmaceutical device doesn’t comply with MHRA? Try rubber extrusions


The Medicines and Healthcare Products Regulatory Agency (MHRA) ensures the safety and quality of medical devices and components. Even if your pharmaceutical device does not require a pre-market submission, it’s your responsibility to make sure that your product complies with legal requirements. A good idea is to use rubber extrusions UK. Rubber parts are largely used throughout the pharmaceutical world, where components must meet with MHRA regulations. They act both as seals and edging trims. No matter if you are manufacturing bulk drug equipment or compressors, use rubber extrusions. The success of your product is guaranteed. You will not have to tear it apart and start over.

What rubber extrusions are

Extrusions are objects produced by extruding. They are manufactured from materials like rubber, thermoplastics and thermoplastic rubber. This process offers many advantages. It’s possible to manufacture cross-section pieces and to work with breakable material. This manufacturing process provides benefits to companies and organizations within the engineering and manufacturing industries. Let us not forget about the pharmaceutical industry. Besides the pharmaceutical industry, the parts are used in the marine industry and mass transit applications.

Rubber extrusion materials

Pieces are crafted from a selection of materials and polymers, like EPDM, Neoprene. Butyl, Silicone and Viton. Depending on the material used, the material can be rigid or flexible. There is no right material when it comes to manufacturing extrusions since each application is different. For instance, if the environment or working medium where the material will be used is very high in temperature, then it is not possible to use just any material. When commissioning rubber extrusions give sufficient information about how your pharmaceutical device will be used. Get assistance from the manufacturer’s design team.

Learning about the rubber extrusion process

The material is pushed through a die of a cross-sectional profile under pressure of an extrusion machine. Extruded rubber products are not subject to the process of vulcanization. This means that their original shape is not altered. The product is vulcanised only when it is rendered usable. What happens is that the unvulcanised object is fed into an extruder, after which it is pushed through a die, a special tool, and forced through the openings. Many of the compounds shrink when passing through the die. However, the length of the final product is reduced in dimension.

The bottom line

If you ever get involved in the manufacture of pharmaceutical components, you will see that there are many regulations that you have to navigate through. To ensure that your device complies with Medicines and Healthcare products Regulatory Agency regulatory standards, use rubber parts. Most companies offer design services, so you can be sure that the object will fit the application. If tis i necessary, a prototype will be made so that the product can be tested. Thanks to these components, you will be able to bring your device on the market. You will not have sealing or finishing problems. If you do not use rubber extrusions, it may be necessary to rebuild or redesign your pharmaceutical device. This is the last thing you want.