Quality Assurance: What to Ask Your Cleanroom Manufacturer

When it comes to medical manufacturing, quality assurance is paramount.

Companies need to know their cleanroom vendors have the capabilities, facilities and safeguards in place to meet compliance and safety standards.

At Janco, Inc, our cleanroom manufacturing facilities adhere to the highest standards and are ISO certified and FDA registered. Companies throughout the Greater Boston area have come to rely on us to provide cleanroom manufacturing and packaging services thanks in part to our focus on quality and reliability.

In this post, we’ll discuss our certifications and cover the cleanroom capabilities and facilities you’ll find at Janco’s headquarters in Rollinsford, NH.

About the Cleanroom Manufacturing Environment

A cleanroom is a regulated environment designed to control contamination by removing unwanted particles from the air, like dust and microbes. Cleanrooms are often required for manufacturing items where these small particles can affect the quality of the product, and are required for manufacturing within the medical device and pharmaceutical industry.

Cleanrooms are generally classified defined by two factors:

1. Amount of air changes per hour – the number of times that air is filtered through HEPA (High-Efficiency Particulate Air) filters.
2. Numbers of particles they allow – To reduce particles in the air during the process, cleanrooms will have increased air filtering.

Our Cleanroom Certifications

All our cleanrooms are monitored and tested regularly to maintain our ISO 14644-1 Class 7 and Class 8 certification and our ISO 13485 certification. In addition, our medical manufacturing facilities are FDA registered.

This includes frequent auditing through internal, independent, FDA and customer inspections. Our staff includes an Exemplar Global certified Internal Quality Management System Auditor and a CERTUS Certified ISO 19011 Internal Auditor.

What Does Class 7 & 8 Mean?

ISO standards define classes by the number of particles allowed per square foot of air, with each class allowing 10 times fewer particles than the class above it. Class 8 cleanrooms can have 100,000 particles per square foot of air, whereas Class 7 cleanrooms can have only 10,000.

Your company likely knows the class of cleanroom needed, depending on the product or packaging you’re manufacturing. In those instances where you’re looking for insights on the level of cleanroom needed, we are here to work with customers to provide the right solution for their needs.

Our Cleanroom Manufacturing Capabilities

After establishing a manufacturer can meet your cleanroom specifications, next, determine if they use the materials you need and have the right capabilities.

As a cleanroom vendor, we offer manufacturing capabilities using foam or plastic materials. This includes non-sterile, or sterile class I, II, III medical devices and packaging. We also offer a wide range of capabilities:

1. Thermoforming using high-performance foam and plastic.
2. Compression molding for sterile packaging of parts as large as 30 inches by 60 inches.
3. Die cutting at our facility offers a high level of intricacy and customization.
4. Medical device assembly includes a wide range of high-quality services, from hand assembly to fulfillment.
5. Medical packaging, including unique design and manufacturing needs using state-of-the-art equipment and materials.
6. Medical laminating used to combine two materials, often including foams or fabrics, for several types of medical products up to 60 inches wide.
7. Medical RF sealing is used to bond two layers of material together by using radio frequency (RF) energy and may be a key final step in critical medical products.
8. Medical CNC milling, or Computer Numerical Control (CNC) Milling, is a machining process using computerized controls and rotating multi-point cutting for precision.

In addition to our manufacturing capabilities, our design team can help develop packaging that ensures you’re getting the most effective product possible.

The Janco Difference

Our state-of-the-art cleanroom manufacturing facilities offer our customers not only quality assurance, but also peace of mind. Janco offers customers decades of experience, a packaging design team, and a dedication to quality. Whatever your medical device assembly or packaging needs, we are able to efficiently and effectively meet your needs.