Frequently Asked Questions: Cleanroom Manufacturing

Our cleanrooms merge precision with innovation to bring your most essential medical manufacturing projects to life.

Contract manufacturing across several industries means that our team has to be well-versed in protocols, standards, and procedures for several unique sets of needs. When it comes to medical manufacturing, utilizing cleanrooms is one of the most essential parts of our work.

Our team uses cleanrooms to manufacture products and packaging essential to our clients, with different classifications of cleanrooms in our facilities to accommodate different needs. We’ve also recently built a brand new cleanroom, dubbed ‘The Foam Center of Excellence’, to accommodate larger-scale projects with new capabilities.

Want to know how cleanroom manufacturing works? Below, we answer all of your burning questions, from general FAQ to info about our specific in-house capabilities.

What is a cleanroom?

A cleanroom is designed to maintain low concentrations of particulates during the manufacturing of certain products and packaging. The rooms are highly controlled and isolated from several forms of contamination, ranging from dust and vaporized particles to other airborne organisms, ensuring that the products handled in the cleanroom remain sterile.

For uses outside of manufacturing, including nuclear work and hazardous biology, cleanrooms are used to contain potentially harmful materials from escaping the room and contaminating the surrounding environment.

What is cleanroom manufacturing?

Cleanroom manufacturing refers to any manufacturing process completed in a cleanroom. At Janco, we use cleanrooms for a range of customized medical products and packaging. Our cleanroom manufacturing capabilities include thermoforming, compression molding, die cutting, RF sealing, medical device assembly, and medical product packaging.

We work with several different foams and plastics in our manufacturing processes, depending on the needs of any individual project.

What are cleanrooms used for?

Cleanrooms are used for several medical projects, ranging from trays and blister packs to mouthguards and device packaging. We assess projects based on their unique needs to determine which of our cleanrooms they need to be manufactured in.

What products are commonly manufactured in a cleanroom?

A wide range of medical products is assembled and packaged in our cleanroom facilities, ranging from custom medical trays to packaging for medical devices. Our newest cleanroom boasts the largest capabilities in the industry; we have the capabilities to manufacture foam products for the biotech and pharmaceutical industry.

In one of our class 8 cleanrooms, we’ve built the capacity to machine parts as large as 30” by 60”, ideal for large trays used for catheters.

We also commonly use our cleanrooms to manufacture:

• Custom backing cards
• Case inserts
• Defibrillator pads
• Grounding pads
• Hip stem foam products.
• IV filters
• Medical packaging accessories
• Reagent Reservoirs
• Reamer products
• Skin contact tapes, foams, and seals
• Transdermal patches
• Wound closures

What are cleanroom requirements?

Cleanroom requirements depend on several factors, including the unique classification given to the room. Classifications are used to define what type of products can be manufactured in a specific room and depend on how the cleanroom is built and maintained.

How are cleanrooms classified?

Cleanroom classifications are defined by two main factors, the first being the number of air changes per hour. Air changes per hour refer to the number of times that air is filtered through High-Efficiency Particulate Air (HEPA) filters in the room. The second factor considered is the number of particles that the cleanroom allows; by increasing the filters, fewer particles are left in the air during the process.

Each class allows ten times fewer particles than the class above it. So, Class 8 cleanrooms can allow 100,000 particles per square foot of air, and Class 7 cleanrooms can have only 10,000.

The cleanroom needed for any given manufacturing project depends on the product or packaging type.

What classification of cleanrooms does Janco have?

The medical manufacturing division at Janco is ISO 13485 certified and FDA registered. We have multiple cleanrooms ranging from ISO 14644-1 Class 7 to Class 8. All of our cleanrooms are regularly tested and continuously monitored to guarantee that they are operating within the required parameters for their classification.

In addition, all medical manufacturing processes in our facilities are frequently audited through internal, independent, and FDA inspections.

Cleanroom Manufacturing with Janco

For decades, Janco has been a trusted name in medical contract manufacturing thanks to our innovative facilities, top-notch quality assurance, and expert staff.

We pride ourselves on going above and beyond for clients, striving to find ways to add value to every project throughout the manufacturing process, assisting with everything from material selection to designing before we begin manufacturing.

With Janco, you have peace of mind knowing that our team is always improving how we operate, ensuring our engineers are versed in the latest technology and our facilities are up-to-date with the most innovative systems and processes.

Do you have a project that requires cleanroom manufacturing or want to learn more about our manufacturing capabilities?

Get in touch with us!