Innovative contract manufacturing solutions for the medical industry start with state-of-the-art cleanrooms.
ISO-certified cleanrooms are an essential part of the manufacturing process to ensure the quality of your medical packaging isn’t compromised.
Our team has spent decades providing value-add solutions for the medical industry, utilizing our state-of-the-art cleanrooms to bring a wide range of medical packaging needs to life. From design to creation, you have a team of experts offering guidance every step of the way.
Cleanroom Capabilities
Our cleanroom capabilities are wide-ranging, and include:
- Thermoforming
- Compression molding
- Die cutting
- Medical device assembly
- Medical packaging
With access to a large network of trusted vendors, our team can ensure that your project is manufactured with foam or plastic materials suitable for non-sterile, or sterile class I, II, III medical devices and packaging.
We’ll assist you throughout the design phase to add value to your packaging, so even before we enter the cleanroom to bring it to life, you’ll know you’re getting the most effective product possible.
Our medical manufacturing division is ISO 13485 certified and FDA registered.
Our ISO 14644-1 Class 7 and Class 8 certified cleanrooms are monitored and tested regularly to assure that they are operating within required parameters. Plus, all of our medical processes are audited frequently through internal, independent, and FDA inspections.
Designed to keep pollutants, particles, and other contaminants from affecting your product, our cleanrooms give you peace of mind knowing that your packaging will be as secure and sterile as you need it to be.
Generally, classifications of cleanrooms are defined by two factors:
- Amount of air changes per hour
- Numbers of particles they allow
Air changes per hour refer to the number of times that air is filtered through HEPA (High-Efficiency Particulate Air) filters. Increased filtering means fewer particles are in the air during the process.
In terms of particles allowed, each class allows ten times fewer particles than the class above it. Class 8 cleanrooms can have 100,000 particles per cubic foot of air, whereas Class 7 cleanrooms can have only 10,000.
The cleanroom needed depends on the product or packaging type being manufactured.
Our entire process is built with quality assurance in mind, from our manufacturing division to sales, design, and production. By constantly collecting data, analyzing our findings, and adjusting processes accordingly, our manufacturing capabilities are constantly being improved.
The medical device and packaging inspection staff at Janco perform meticulous validation testing according to ASTM, ISO, or custom standards, depending on your application. Janco medical products offer complete traceability from individual product ID, back to the raw material lot number.