White Wall Medical Molding: Non-Cleanroom Silicone Injection Molding

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.

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.

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.

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.

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.