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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A doctor’s duty, above all else, is to ensure the safety of their patient. Part of that means knowing that the instruments and tools they use throughout treatment are safe and sterile, which comes down to how those instruments are manufactured, packaged, and handled.

At Janco, our team has served the medical industry for six decades. Our quality assurance processes, understanding of unique industry standards, and cleanroom capabilities are second to none. Below, we answer the most common questions surrounding manufacturing for medical packaging in our own facility and beyond.

Is sterile packaging used for medical devices?

Yes, sterile packaging is used for several types of medical devices, including surgical instruments, catheters, single-use instrument trays, and more.

Why do we sterilize packaging materials?

Sterile packaging is an essential component of contract medical manufacturing. When surgeons and doctors utilize certain instruments on patients, it’s crucial that those instruments are kept free of particulates and other contaminants that may harm the patient. Surgical trays, for example, which can contain a wide range of instruments and tools, have to be kept sterile before entering the operating room, as any contamination can lead to infections and other complications with the patient.

Patient safety is the main priority of every doctor, so ensuring the sterility of medical instruments and devices used for treatment or surgery is key to the effectiveness of the duty. Sterile instruments prevent the spread of disease and bacterial infections.

How are packaging materials sterilized?

There are a number of potential methods to sterilize packaging materials. Our team manufactures packaging and products in sterile environments, our ISO-certified class 7 and 8 cleanrooms, and then sends them to an outside partner to be sterilized.

Cleanrooms ensure that products and packaging aren’t compromised by particulates and other contaminants that could compromise the devices or instruments.

What are the types of sterilization?

Methods of sterilization include ETO, gamma, e-beam, steam autoclave, and dry heat. The chosen method depends on the material used to package a product, ranging from plastic or paper to Polyfilm plastic tubing.

What is the shelf life of a sterile package?

According to the CDC, practices for sterilized instruments can be based on either date of sterilization or specific events, such as the packaging being opened. Some facilities put dates on every sterilized package based on shelf-life practices, but it’s more common that manufacturers utilize event-related shelf-life recommendations. This dictates that instruments or devices should remain sterile until a specific event causes contamination. That could include the pouch or seal being intentionally opened, accidentally torn or scratched, or wet.

Regardless of the date or event, all packages that require the internal instruments or devices to remain sterile should always be thoroughly inspected before use to verify that the package is not wet, torn, or damaged in any way. In some cases, the contents of the package may need to be resterilized before they can be used by doctors or surgeons.

Can you write on sterile packaging?

If writing is done on a sterilized package, it should be done on the plastic side, if there is one, and should be done using a non-toxic marker. This is because the plastic portion of the packaging is not permeable to the sterilant and will keep the content protected.

Labels for sterilized packages should typically include the date of sterilization, the expiration date (if there is one), and the type of sterilization used.

What is Tyvek® packaging?

Tyvek® is high-density polyethylene used to create pouches for sterile packaging needs. Its makeup, which consists of continuous filaments, creates a barrier that blocks particulates, microbes, and other contaminants from entering the pouch. Most commonly, Tyvek® pouches are often used for implants and other medical devices.

Our team purchases pouches from our circle of trusted vendors, performing the sealing in our facilities using a pouch sealer in our class 7 cleanroom.

Medical Manufacturing with Janco

Our team has experience working across several sectors of the medical industry on contract manufacturing projects, including:
​

• Orthopedics
• Vascular
• Respiratory
• Endoscopy
• Laboratory
• Cardiology
• Ophthalmic
• Spinal and Biologics
• Dental
• Pharmaceutical
• Veterinary

Several of these fields require sterilized packaging to insure devices, instruments, and other tools are kept safe from contamination by particulates and other matter.

Ready to get started on your next project?

If you have questions about our process, want to know more about our team, or have a medical manufacturing project requiring sterile packaging that you think Janco can help add value to, reach out to us.

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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 industrial  contract 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!

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As a manufacturer of medical products and packaging, one of our most essential functions is understanding and implementing the important standards that govern the industry. Ensuring that the products we manufacture follow strict medical industry guidelines is essential, including using the right tools and processes to prepare packaging and products for sterilization.

Why Sterilized Packaging is Important

Protecting patients is every doctor’s main priority, which is why it’s critical to make sure that medical instruments and devices used during surgery or treatment are sterile. Sterile medical devices and instruments help doctors prevent the spread of bacterial infections or diseases, effectively lowering the risk of avoidable complications.

The manufacturing and packaging of those instruments and devices are crucial to achieving and maintaining sterility. Thorough testing and various forms of validation are conducted on the packaging of most medical instruments to guarantee that they will remain sterile up until they are used in surgery or treatment.

Our Process

Janco purchases Tyvek® pouches (often used for implants and other medical devices) from a trusted circle of vendors, and we perform the sealing ourselves using a pouch sealer in our class 7 cleanroom.

For other projects, TPU sleeves are created in our ISO-certified class 8 cleanroom, sealing two sheets together before then placing them into a Tyvek® pouch and sealing the entire thing.

Within our state-of-the-art facilities, our team has the capacity to manufacture both small and large-scale production runs, depending on the needs of each client.

Sterile Product Packaging

Some of our most commonly-manufactured sterile products are medical trays made of thermoformed plastic. Thermoformed trays are both cost-effective and customizable, making them an ideal packaging option to keep medical devices and instruments secure.

We work with a wide range of medical sectors, including:

• Cardiology
• Orthopedics
• Vascular
• Respiratory
• Endoscopy
• Laboratory
• Ophthalmic
• Spinal and Biologics
• Dental
• And more

Each discipline has unique needs, so we work with you to customize the design of your trays, and other medical devices, to ensure that all of those needs are met in the most effective way possible.

Medical Manufacturing with Janco

For about six decades, Janco has been a trusted partner for medical manufacturing projects, because our team goes above and beyond to deliver innovation, quality, and customization.

Our thorough quality assurance processes, including frequent internal and external audits, keep our processes running smoothly and safely, so you have peace of mind knowing that your products are being manufactured and packaged with the highest level of quality and care.

Certifications

See all of our certifications here.

• High Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Low Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Packaging ISO 14644-1 Cleanroom Certification-Class 7
• Medical Device Assembly ISO 14644-1 Clean Room Certification- Class 8
• Foam Die Cut/Assembly ISO 14644-1 Clean Room Certification- Class 8
• Foam Molding ISO 14644-1, Cleanroom Certification- Class 8
• ISO 13485 Certification
• FDA Registered Facility

To learn more about our process or to get started on your next medical manufacturing project, reach out to our team today.

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Janco is thrilled to announce the launch of our long-anticipated new class 8 cleanroom. Our team has worked hard to assemble this cleanroom that combines state-of-the-art equipment with cutting-edge capabilities to deliver the precision and innovation that your manufacturing projects rely on to succeed.

Referred to in-house as “The Foam Center of Excellence”, our newest cleanroom boasts the largest capabilities in the industry, able to machine parts as large as 30” by 60”.

Our goal has always been to find innovative solutions to client’s issues, so when a team came to us with the desire to machine parts that were too large for our current facilities, the idea for a new cleanroom was born.

Capabilities

While many of our capabilities are standard throughout each of our cleanrooms, we also added new capabilities and machinery to both expand and improve how we serve you.

Our main objective in creating a new cleanroom from scratch was creating the capabilities to machine large parts that most standard cleanrooms don’t offer, widening the scope of projects that we’re able to take on.

Janco is also excited to offer RF Sealing capabilities, which we’ve added to meet increased demand to form TPU products in cleanroom settings.

Our complete list of capabilities in our newest class 8 cleanroom include:

• Compression molding
• RF welding
• Die cutting
• Oven operation
• Assembly

Cleanroom Manufacturing

Why are cleanrooms essential?

Cleanrooms are engineered to keep particles, contaminants, and other pollutants from interfering with your product or packaging. Cleanroom manufacturing ensures that your medical device or packaging will be sterilized and secure in line with industry standards.

How do classifications work?

Cleanroom classifications are based on the number of air changes that occur per hour as well as the number of particles that the room allows. Here’s how it works:

• Cleanrooms utilize High-Efficiency Particle Air (HEPA) Filters. Increasing the number of air changes means that fewer particles will be in the air throughout manufacturing.
• In terms of the number of particles allowed, each class of cleanroom allows ten times fewer particles than the class above it.
• Class 8 cleanrooms allow 100,000 particles per square foot of air and Class 7 cleanrooms can allow only 10,000.
• The cleanroom needed for a project will depend on the type of product or type of packaging being manufactured and the unique standards that regulate it.

What are Janco’s classifications?

The medical manufacturing division at Janco is ISO 13485 certified and registered with the FDA.
All of our cleanrooms, both class 7 and class 8, are regularly monitored and tested to provide peace of mind that they are operating within required parameters.

Quality Assurance

How we monitor cleanroom efficiency

Our quality management system is integrated into every aspect of how we run our operations, from our cleanrooms and medical manufacturing division to sales, design, production, and customer support.

A great deal of diligence and upkeep goes into keeping the cleanrooms used to manufacture your products running at peak performance on every job. Our team is committed to ongoing investments and improvements when it comes to our equipment and facilities. On top of that, we’re dedicated to ongoing education and training for our personnel.

Our team is consistently improving how we bring your products to life, using a process that includes collecting data, analyzing trends, and creating new or revised process control documents. Our controlled document records are thoroughly maintained and secured to guarantee confidentiality, transparency, and accountability to our clients.

Your changing needs lead to constant innovation

When clients came to us with the need to have larger parts manufactured, our team decided to invest in new, high-quality equipment that would give us the capabilities to take on a whole new set of jobs through the medical sector.

The medical device and packaging inspection staff that will review your products or packaging perform meticulous validation testing following standards laid out by ASTM, ISO, as well as your custom project requirements. We ensure that the medical products we manufacture offer complete traceability from individual product ID to raw material lot numbers.

About Janco

Our history

Janco is a family-owned business with six decades of experience in industrial contract manufacturing, ranging from the medical industry to automotive and athletic sectors and beyond. Our team of engineers and project managers specializes in high-quality thermoforming and compression molding services across a wide range of industries.

During every project, our team leads with the principle that we treat our clients with the same level of respect and support that we’d give our own family.

Our mission is to make the manufacturing process simple for you, answer all of your questions, offer innovative solutions for unique projects, and use cutting-edge technology to add value to your product or packaging.

As a distributor of high-quality foam and plastic who has relationships built on decades of mutual support, our team gives you access to a large network of trusted vendors. That means we’re able to ensure your projects are completed with the best materials suitable for non-sterile or sterile class I, II, III medical devices and packaging.

Our dedication to improving your bottom line and making the process as seamless as possible is why so many of our clients have turned into long-term partners over the years.

Have a manufacturing project that Janco can help with?

Get in touch with our team to learn more about our new class 8 cleanroom and discuss how we can help bring your next project to life.

The post Introducing Janco’s New Cleanroom! appeared first on Janco Inc.

A cleanroom is instrumental in creating a controlled environment where pollutants like dust, airborne microbes, and aerosol particles can’t disrupt the manufacturing process.

Cleanrooms are used for a wide range of manufacturing and scientific projects, including industrial, electronics, aerospace, and medical packaging processes that require high levels of scrutiny and care.

The main job of a cleanroom is to stop pollutants, particles, and contaminants from disrupting the manufacturing process. Cleanrooms give those operating the room total control of the environment where they’re working, allowing for the adjustment of temperature, airflow, and humidity in accordance with unique project needs.

Because of these strict limitations and guidelines, common project materials such as pencils, paper, and even many typical fabrics made from natural fibers aren’t allowed within the space.

Common Cleanroom Manufacturing Projects

Whenever you’re manufacturing something that might be easily affected by contaminants or air particles, you should be operating in a cleanroom with proper protocols. There are also industry standards specific to medical packaging that require cleanroom facilities to be used.

These are a few markets within the medical industry where our team frequently utilizes cleanroom manufacturing:

• Orthopedics
• Vascular
• Respiratory
• Endoscopy
• Laboratory
• Cardiology
• Ophthalmic
• Spinal and Biologics
• Dental
• Pharmaceutical
• Veterinary

Cleanroom Classification

Cleanrooms are classified into levels of contamination, a classification that depends on the number of particles allowed in the space, per cubic meter. Different products and devices will require varying levels of cleanroom classification to be manufactured, so you need to check with your manufacturer to ensure that they have the proper facilities to take on your project.

At Janco, our facilities include ISO-certified class 7 and class 8 cleanrooms used for forming, packaging, and assembly projects. Our cleanroom manufacturing facilities are FDA registered, and ISO 13485 & ISO 14464-1 certified. Our full range of certifications include:

• High Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Low Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
• Packaging ISO 14644-1 Cleanroom Certification-Class 7
• Medical Device Assembly ISO 14644-1 Clean Room Certification- Class 8
• Foam Die Cut/Assembly ISO 14644-1 Clean Room Certification- Class 8
• ISO 13485 Certification
• FDA Registered Facility

Have a project that requires Cleanroom Manufacturing?

Get in touch with Janco to learn more about how our team can help with your cleanroom manufacturing needs.

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