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USP Class VI compliant release agent helps medical manufacturers boost production.

May 29, 2014
George Barton

An aging North American population and an expanding healthcare industry in Asia are among the factors driving demand for all types of medical devices. These trends, combined with the move to replace traditional reusable equipment with disposable products for safety and convenience, are increasing the need for sterilized plastic and medical-grade rubber. Among products where demand is greatest are syringe cups and vial stoppers.

According to The Freedonia Group, the U.S. disposable medical supply industry is expected to expand more than 4% annually to nearly $50 billion by 2018. Overseeing the safety of the industry is the United States Pharmacopeial Convention, the official public standards-setting authority for all healthcare products manufactured and sold in the U.S. and 130 other countries. The USP has developed six classes to safeguard the quality, purity, strength, and consistency of products used in the pharmaceutical and biotechnology industries. To pass Class VI – its toughest class – products are subject to the strictest biological tests. For a rubber compound material to pass Class VI certification, it must exhibit a very low level of toxicity. That means having a clean history of biocompatibility, meeting tight requirements for leachates.

Rubber manufacturers must demonstrate compliance with all USP-applicable statuary, regulatory, and healthcare industry requirements for each product produced.

This is no easy hurdle to jump. Obtaining such status can be a lengthy and arduous process, but the benefit of passing this panel of USP testing cannot be overstated. Rubber manufacturers that achieve a USP Class VI Certification of Compliance can expect favorable consideration for use in pharmaceutical manufacturing, diagnostic and surgical instruments, and other non-implantable medical devices. To manufacturers in the rubber molding industry, a Certificate of Compliance is a business imperative and is recognized around the world as proof of having met the gold standard for biocompatibility. Once a product receives this level of clearance, it telegraphs an important level of assurance to customers looking to purchase component materials.

Release agents’ benefits

The perfect medical component is one that can increase a manufacturer’s production efficiency as well as enable its compliance with USP Class VI. One such product is Chem-Trend’s Mono-Coat 1973W, a durable, semi-permanent, water-based release agent used in molding medical rubber components. In biological compatibility tests conducted by the independent testing laboratory NAMSA, Mono-Coat 1973W was found to meet the uncompromising requirements of USP Class VI.

Mono-Coat 1973W provides many benefits to syringe and blood vial manufacturers, as well as makers of syringe cups, vial stoppers and other rubber components. In addition to being biocompatible, Mono-Coat 1973W helps manufacturers increase part quality, improve throughput, and refine manufacturing efficiency.

In general, mold release agents provide a physical and/or chemical barrier as a means to separate the material being molded from the mold surface. These agents can impact process characteristics such as the rate of material flow inside the mold cavity, machine cycle time, and release ease. The choice of mold release agents also affects the finish qualities of parts, including gloss levels, texture, and compatibility with post-molding operations such as gluing, painting, welding, or coating. Release agents can increase mold life, prolong maintenance cycles, and boost overall productivity.

For specific medical-component applications, Mono-Coat 1973W is sprayed on a mold surface before rubber compounds are molded to ensure easy release and proper manufacture. If parts don’t release from the mold cleanly, scrap parts increase, mold cleaning leads to unscheduled downtime, equipment experiences extra stress, and costs increase for material, labor, shipping, and energy. With Mono-Coat 1973W, that waste can be avoided.

Water-based, gentle on environment

Mono-Coat 1973W is water based and has none of the undesirable properties of solvent-based release agents. When applied to a hot mold, Mono-Coat 1973W emits only steam into the atmosphere. Mold release agents are consumed in the molding process, which is why they must be certified as biocompatible in the event of any transfer to the end product. Mono-Coat 1973W is durable enough to allow for several molding cycles before it is exhausted and reapplication is required.

Mold release agents represent an added-value proposition that can be tailored to many types of molding applications. With Mono-Coat 1973W, manufacturers can:

  • Obtain multiple mold releases between applications
  • Attain more molding cycles per working shift due to efficient release and less frequent release system applications
  • Experience a cleaner working environment
  • Reduce scrap and material use
  • Extend production time due to the low contribution by the release system to in-mold buildup and high mold protection properties
  • Manufacture complicated parts in a trouble-free manner
  • Mold parts with consistently good cosmetic appearance
  • Conduct a variety of post-mold operations, such as paint or glue, with little or no surface preparation


Benefits of release agents transfer between industries

It makes business sense to apply the benefits of release agents to any industry that molds rubber. First and foremost, release agents help industrial manufacturers produce parts that have minute tolerances, require extreme precisions, and can be formulated to exacting specifications. Those same demanding requirements exist in industries besides medical manufacturing. Additionally, industrial manufacturers have become highly sophisticated and face a variety of manufacturing complexities, regulatory considerations, audit, and compliance issues.

Many molders of plastic and rubber components are capable of transitioning between industries if they utilize the processes that enable efficient production. To that end, release agents are becoming integrated in every segment where rubber and plastic are molded. Being certified to the USP Class VI standard for use in the medical rubber market allows for widespread use of release agents such as Mono-Coat 1973W.



About the author: George Barton is a senior development director at Chem-Trend and can be reached at