Why medical-grade silicones remain the best choice for medical and bioprocessing tubing  

For over 60 years, medical-grade silicones have been used throughout the healthcare trade. Initially used to coat glassware, each the pharmaceutical and medical system trade now utilise medical-grade silicones in all the things from orthotics and prosthetics, to wound care and drug eluting units. 

As a result of medical-grade silicone Warmth Remedy Rubber (HCR) is well extrudable, inert and stays steady beneath completely different situations, it is a perfect alternative for the manufacture of tubing for pharmaceutical processing based mostly on dwelling organisms, additionally known as bioprocessing. 

Moreover, medical-grade silicone is hydrophobic and micro organism resistant. These properties, alongside being mushy to the contact and conformable, signifies that medical-grade silicone can also be preferrred for implantable units. Whether or not utilized on or beneath the pores and skin, silicone’s biocompatible materials ensures it’s secure to make use of in long-term implants corresponding to drug eluting units and catheters. 

Utilizing medical grade silicones for biologics manufacturing: fluid switch 

Globally, biologics are the quickest rising phase within the pharmaceutical trade. Biologic medicines are created through the use of dwelling cells, with examples together with gene and stem cell therapies and monoclonal antibodies. Providing excessive efficacy and modern therapies, they’re quickly changing into indispensable within the remedy of persistent and complicated ailments. Biologics have additionally been instrumental within the battle in opposition to the coronavirus. 

The demand for biologics is additional fuelled by the rising want for superior medicine and coverings on account of a rising aged inhabitants, and the biologic outsourcing trade is experiencing elevated regulatory approvals. In response to GlobalData, gross sales of biologics are forecast to be $120bn larger than small molecule gross sales by 2027.  

Clément des Courières is regional market supervisor at Elkem Silicones, one of many world’s main suppliers of superior medical-grade silicones, and he tells us why silicone is so important to the manufacturing of biologics. 

“Inside bioprocessing, numerous tubing are used as elements of Single-Use assemblies,” he explains. “These Single-Use techniques have changed the usage of chrome steel within the synthesis of organic medicine, as they require a really sterile and inert atmosphere. To switch fluids from completely different components of the method, tubing is used, and medical-grade silicone is the fabric of alternative, being proof against strain and inherently elastic. Moreover, it will probably simply be sterilised so is right for use in pumps to switch fluids throughout the manufacturing course of.” 

Medical-grade silicone tubing is made by means of extrusion, and Elkem gives extrusion-grade merchandise which are produced in clear situations. These supplies are straightforward and environment friendly to extrude with no defects, says des Courières: 

“Inside Warmth Remedy Rubber applied sciences, you might have two important sorts, peroxide remedy or platinum cures, and we provide each applied sciences as a part of our Silbione™ model.” 

Excessive efficiency medical-grade silicones provide a number of key benefits: 

Thermal stability – Silicone tubing and assemblies are steady between temperatures of -80 °C to +215 °C 

Excessive purity – Silicones possess a low extractables and leachables profile (which may work together with the method) making them good for pharma manufacturing processes. 

Simply sterilisable – Silicone tubing and assemblies might be sterilised by means of strategies corresponding to Gamma, Autoclave or ETO with little affect to the polymer’s efficiency. 

Confirmed efficiency – Silicones have been efficiently used for greater than 30 years in fluid switch for pharma manufacturing. Moreover, biocompatibility of Silbione™ biomedical grade silicones is examined based on ISO 10993/USP Class VI procedures. 

Utilizing medical-grade silicones for implants and catheters 

In relation to implantable medical units, corresponding to catheters, medical-grade silicones are preferrred as they’re biocompatible, hypoallergenic and sterilisable. As catheters are tubes for fluid switch that often come into contact with human pores and skin, additionally they must be mushy and cozy for the affected person. 

With low shrinkage, excessive resiliency, and cost-effective processing by extrusion, medical-grade warmth remedy rubber (HCR) is a well-liked alternative for catheter tubing. Des Courières notes that though different supplies can be found, like PVC or thermoplastics, they comprise plasticisers or residual monomers, elevating security considerations. 

“Medical-grade silicones are a confirmed know-how, and it’s additionally right here to remain – the know-how of alternative for the long run,” he says. “They inherently have the softness with out the necessity for plasticisers.” 

HCRs are perfect for making medical system components, balloon catheters and extruded tubing. Elkem’s Silbione™ product line is broadly used for producing high-quality components for the healthcare market on account of its straightforward milling and extrusion, good readability, excessive mechanical power, temperature resistance, and high-performance bodily properties. 

Des Courières provides that in addition to Elkem’s medical-grade silicone being based mostly on a confirmed know-how with over 60 years of historical past, Elkem’s world base can be a profit for his or her prospects: 

“We’re a world built-in firm and have manufacturing websites for these ranges distributed all over the world, so we are able to help our prospects’ wants.” 

For extra particulars of medical-grade silicone applied sciences, obtain the free paper beneath. 


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