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.

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Not only do we adhere to regulatory standards for medical manufacturing, but we also see quality as an essential part of our business. We actively practice lean manufacturing and quality management principles to ensure our products meet the exact customer specifications and that we can offer the best product possible.

Part of this means ensuring employees have the training and professional development they need to be successful. In this post, we’ll discuss our certifications and training programs for employees and how we help develop talented team members.

Janco Certifications and Training Requirements

Janco holds a number of certifications relating to medical device assembly, thermoforming, foam molding and packaging. Our certifications include:

ISO 13485 – Janco’s medical manufacturing division is certified to ISO 13485 for the design, manufacture, sale and distribution of plastic and foam packaging; and the contract medical manufacture and contract medical packaging of customer-supplied, customer-distributed sterile and/or non-sterile devices.

ISO 14644-1 – Our Class 7 and Class 8 certified cleanrooms are monitored and tested regularly to assure that they are operating within required parameters. This includes:

• High-volume thermoforming
• Low-volume thermoforming
• Medical device assembly
• Foam die cut/assembly
• Packaging
• Foam molding

In addition to these certifications, all of our medical processes are audited frequently through internal, independent, and FDA inspections.

Employee Training and Professional Development

To keep workers safe, maintain a high-level of quality, and ensure compliance, Janco offers a number of opportunities for employee training.

Before a new employee begins, they are given ISO training to ensure they adhere to the standards and practices these certifications require. This includes:

• Defining the knowledge and skills needed to do their job.
• Providing training or other learning activities that will develop the knowledge and skills they need.
• Testing employees on this knowledge and their skills to prove whether the training was effective.
• Ensuring employees understand how their job activities contribute to the overall quality goals of the company, as well as why their role is important.
• Keeping training records and tracking each employee’s education, skills and experience.

In addition to new hire training, Janco also offers cross training and professional development for employees who want the opportunity to learn new roles and cover other jobs in the event of absences. This training creates opportunities for taking on additional responsibilities, which Janco rewards with merit salary increases.

What Makes Janco a Great Place to Work

Janco, Inc. is a family-owned business that values its employees. Having been in business for over 60 years, we know the importance of having employees with a positive attitude, who are willing to learn and take quality and safety seriously.

When you join the Janco team, you get not only training, but we also offer competitive wages along with medical and dental plans, 10 paid holidays per year, paid vacation time, 401K plan, along with a company paid life insurance policy for all of its full time employees.

Join a motivated, professional team.

Janco, Inc. is always seeking good production workers and technical staff. View our job openings today.

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Operating in the field of medical packaging requires strict adherence to a set of unique industry standards. Several important steps have to be taken to authenticate the integrity of materials, sealing, and even how packaging will age over time.

So, what do you need to know about FDA requirements and regulations?

The good news is, we can take care of all of it for you, from design to labeling, but it’s still important to understand why these regulations exist and how seriously we take them.

FDA Regulations for Medical Packaging

When medication (such as tablets) or medical devices are packaged, the integrity of their storage – whether it be pouches, trays, or blister packs – is of the utmost importance. The journey from packaging to shipping to storage and handling is a long one, and the contained device or medication needs to remain untampered with.

This is exactly why a wide range of medical packaging regulations exist, to ensure that every project is approached with the appropriate level of care and sterilization. Regulations dictate parameters for every part of the process, including:

• Design
• Manufacturing
• Packaging
• Labeling
• Storing
• Servicing

“Because the FDA has rigorous standards for the sterility of medical devices it approves, manufacturers must undergo thorough testing to demonstrate a package’s resistance to environmental factors that might threaten the sterility of its contents,” Jason Haider, founder and CEO of Xenco Medical, explains. “This testing protects against factors such as the transport and aging of the packaging material itself, which could weaken over time and expose the contents to pathogens.”

“Packaging must undergo a spectrum of validating tests to demonstrate their ability to withstand environmental factors. These tests include bubble-emission and burst testing, among others.”

Medical Device Labeling Regulations

Even the labeling of medical devices is highly regulated, as outlined through several articles on the FDA’s official website. The requirements dictate that the following must be included on any label:

• A statement identifying the commodity that is packaged (tablets, sponges, medical implants, etc.).
• The name and place of business of the manufacturer, packer, and/or distributor.
• The number of contents in terms of weight, measure, or numerical count.

Janco’s Medical Packaging Process

Understanding the comprehensive regulations and requirements in place, Janco employs a meticulous process to guarantee that your medical packaging projects are manufactured with strict adherence to the appropriate procedures. (See our certifications here.)

Here’s what you need to know about our process:

• Our medical device and packaging inspection staff carry out diligent and comprehensive validation testing according to ASTM, ISO, or other custom industry standards, depending on your application.
• Any medical products manufactured at Janco offer complete traceability from individual product ID, back to raw material lot numbers.
• Janco’s medical manufacturing division is certified to ISO 13485 and FDA registered.
• Our ISO 14644-1 Class 7 and Class 8 certified cleanrooms undergo ongoing monitoring and testing to assure that they are operating within their required parameters.
• All of our medical packaging processes are regularly audited and verified through internal, independent, FDA, and customer assessments.

At Janco, we understand that the success of your medical packaging is determined by the efficiency of its manufacturing. That’s why we’ve invested in the most innovative and effective technology to ensure that the packaging and products we create adhere strictly to FDA medical packaging guidelines.

Need an expert team to carry out a custom medical packaging project?

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