Silicones vs. TPEs for Infant Care Products

Posted by Mike Fil on April 15, 2019

Designers of infant care products need safe, clean materials with the right performance properties and processing capabilities. Silicones, a group of synthetic elastomers, are used in baby care products such as pacifiers, baby bottle nipples , feeding sets, sippy tops ,...

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Choosing the Right Color for Your Silicone or Plastic Product

Posted by Corie Yodis on March 2, 2018

The color of your plastic or silicone product can make all the difference, especially for your consumers. It’s the first thing any customer will see of a product and can make a real impact on sales. The right color choice can set you apart from competitors and other brands,...

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Silicone Overmolding Secrets

Posted by Mike Fil on July 31, 2019

Silicone overmolding is an injection molding process that molds silicone over, under, or through a substrate material to complete the final part. By allowing product designers to combine the best of two materials, this manufacturing process supports variations in durometer...

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White Wall Medical Molding: Non-Cleanroom Silicone Injection Molding

Posted by Lynn Momrow-Zielinski on November 8, 2018

When it comes to medical and healthcare injection molding, understanding the difference between cleanroom and white wall molding can often be key in helping you to find the right silicone manufacturer for your medical devices and components.

Since we know that the cost associated with producing silicone in cleanrooms can often be a barrier to entry, let’s take a closer look at what white wall molding is and how it could benefit your business:

White Wall Molding Manufacturing Definition

White wall or non-cleanroom molding is a term that refers to silicone injection molding in a facility with clean white walls that is free from airborne contaminants. The white wall facility is not a designated clean room and does not meet the ratings because it lacks air filtration/purification. It is not a clean room, but it is free of contaminants and is perfectly suited to some types of healthcare and medical injection molding products.

non clean room medical moldong

Why Use White Wall Medical Molding?

You can mold many medical components in a white wall facility, and it’s often more cost effective to choose this method. Normally, secondary inspection and cleaning steps will be performed in a rated hood or clean room as required. This approach is much more affordable for molders who split their business across markets because clean rooms can rack up large costs if you’re not careful.

FDA Approved Medical Silicone Manufacturing: Fact or Fiction?

It’s a commonly-held belief that manufacturers of medical grade silicone have to be FDA approved to carry out their operations, but this is fiction. Only companies selling directly to hospitals and doctors need to be FDA approved, contractors do not. And, if you’re making Class I medical devices or any medical components, there’s no need for this at all.

Similarly, many believe that silicone medical device manufacturers must be ISO certified and have clean rooms. While we think it certainly helps to be FDA approved and working towards ISO certifications, you do not need these standards nor should you based your judgement of a silicone manufacturer entirely upon this.

Medical Silicone Components Vs Medical Silicone Devices

There’s a difference between medical components and devices that is nuanced and can often be missed.

Medical components make up the bulk of silicone injection molding, and often do not require a clean room to be made. They do not have FDA classifications. Components are often then placed into devices at a later stage using a cleanroom.

Medical devices, in contrast, are finished devices that have FDA classifications depending on use and intended use that is risk based. These are:

  • Class I – Low Risk, examples of these could include dental floss and toothbrushes
  • Class II – Medium Risk, examples of these could be wheelchairs, contact lenses, ultrasound scanners and condoms
  • Class III – Highest Risk, examples of these would be orthopedic implants
  • Class IV — Implantables

Some medical devices don’t require a clean room, but others do. Class I makes up around 45% of medical device manufacturing and these can be ideally suited for a white wall facility rather than a clean room.

It is important to understand that many devices are made of components, and these medical components can be manufactured in a white wall room while still exceeding expectations. At Extreme Molding the components we produce are suitable for use by medical device manufacturers within the medical devices they are producing.

Reshoring silicone manufacturing in the USA CTA

Finding the Right Medical Silicone Injection Molder

If you’re looking for a high quality, large volume, manufacturer of medical components who can work with your medical device manufacturer contact us today for a free consultation.

Our team of experts will examine your CAD files and be able to offer advice on product development. We have a less than 0.01% reject rate over the last 5 years and over 15 years’ experience in medical injection molding with silicone. Choosing a high-quality manufacturer of silicone who uses white wall rooms could be the key to driving down the overall costs of your medical component project while helping your sales blossom.


Tags: Injection Molding, Healthcare Manufacturing