White Room Manufacturing for Healthcare & Medical Components

White room manufacturing is a controlled production environment designed to maintain high standards of cleanliness without reaching the stricter contamination control levels of a clean room. These spaces are equipped with features like filtered air, positive air pressure, and designated gowning protocols to reduce particulate contamination. White rooms are particularly effective for industries like healthcare, baby products, and food-grade manufacturing where cleanliness is crucial but does not demand the more stringent specifications of cleanrooms.

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.

Benefits of White Room Manufacturing

White room manufacturing is a cost-effective solution for industries that require cleanliness but don’t need the extreme controls of a cleanroom. Some key benefits include:

• Lower Operational Costs: Maintaining a white room environment requires less energy and infrastructure investment compared to a cleanroom.
• Enhanced Product Quality: By minimizing contamination risks, white room facilities ensure the consistent quality of products.
• Regulatory Compliance: White rooms, or non-cleanrooms, meet the necessary ISO and FDA standards for many industries, ensuring safety and reliability.
• Versatility: White rooms are suitable for a variety of applications, including medical devices, baby products, and other sensitive materials.

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 who uses white rooms could be the key to driving down the overall costs of your medical component project while helping your sales improve.