Cleanroom Manufacturing for High-Purity Assemblies
Cleanroom manufacturing at Axenics delivers the precision, purity, and repeatability required for high-performance assemblies in semiconductor, medical, and life sciences production. Every process takes place inside certified Class 100 environments (ISO 5) that maintain exacting controls over airborne particulates, temperature, and humidity.
Within our cleanrooms, every weld, bend, and assembly is executed under conditions that eliminate potential contamination. Axenics’ commitment to contamination-free production defines our leadership in cleanroom manufacturing and high-purity contract assembly.
Class 100 cleanroom manufacturing
Cleanrooms are designed to keep dirt particles or any unwanted particles outside of the environment, so those elements do not contaminate the finished product. There are several classes of distinction, starting at class 1 up to class 10,000, the numbers signifying what is and is not allowed to enter the cleanroom.
Cleanrooms can also be used for a variety of industries where temperature, vibration and humidity need to be precisely controlled.
In Axenics’ class 100 cleanrooms, no paper or cardboard is allowed inside. Any tools being used in the cleanroom must be wiped down before being brought into the space. The interior of the cleanroom is vacuumed, dusted and inspected internally twice per week. Controlling contamination when it comes to cleanroom welding is a top priority, so an air purification/filtration system is utilized as well.
The class 100 cleanrooms are also certified once a year, and Axenics has passed each inspection. Scheduled air-quality testing is performed regularly on the class 100 cleanrooms to ensure particles have not entered the space. This is key in ensuring high-purity results for the gas delivery systems Axenics produces.
What cleanroom manufacturing means at Axenics
Cleanroom manufacturing is a full production discipline, not just a controlled room. Axenics maintains Class 100 (ISO 5) certification through continuous air filtration, positive-pressure control, and rigorous cleanroom entry procedures that ensure zero contamination from personnel. Tools and fixtures are pre-cleaned and vacuumed before entry, while unapproved materials such as paper and cardboard are prohibited. These measures create repeatable, contamination-free results that meet the most demanding semiconductor and life science standards.
Interpretations and solutions
Axenics’ cleanroom manufacturing and problem-solving capabilities extend beyond standard contract assembly. Our engineering team addresses complex challenges in semiconductor, medical device, life science, and alternative energy systems where purity and precision are non-negotiable.
Semiconductors:
High-purity semiconductor cleanroom manufacturing demands precision. Axenics specializes in orbital welding techniques, ensuring the highest joint integrity, minimizing downtime and waste, and ultimately enhancing semiconductor production processes.
Medical devices:
Axenics helps produce intricate medical components, adhering to stringent quality standards. Our tube bending and welding expertise contribute to the reliability and accuracy of medical device components while reducing production costs.
Life sciences:
As research, accuracy and contamination-free processes are essential, Axenics provides custom solutions for equipment, ensuring sterile and precise solutions, from tubing assemblies to manifold systems.
Alternative energy:
Axenics plays a pivotal role in addressing challenges within alternative energy systems, such as hydrogen fuel cell component production. Our team optimizes component manufacturing processes, improving efficiency in sustainable energy solutions.
Additionally, Axenics embraces automation and software solutions to enhance production processes, as evident in projects like the dye system optimization, which ensures precise dye dispensing and reduces technician workload. Axenics uses its extensive experience in metal and plastic fabrication to provide tailored solutions for varied customer needs.
Axenics is committed to solving problems and improving efficiency within our customers’ existing processes, whether through innovative welding techniques, equipment automation, or materials optimization. Our focus remains on delivering reliable, high-quality solutions to the industries we serve.
Relief for your manufacturing headaches
When you face manufacturing challenges that threaten your products’ quality, team efficiency or overall business success, you need someone who can fill in the holes within your business seamlessly. Axenics offers relief to your team by delivering high-purity contract manufacturing solutions that meet the rigorous demands of industries like semiconductor manufacturing, medical device production, life sciences and more.
Precision in every weld
At the heart of Axenics’ high-purity contract manufacturing services is precision welding, where orbital welding on 316L stainless steel takes center stage. Achieving ultra-clean welds is a complex task, especially when working with paper-thin metals. Manual welding often results in slight adjustments that can ruin the weld, but Axenics prefers an orbital weld head for its ability to dial in each section of the tube to perfection before the final weld.
Every orbital weld at Axenics is performed inside a Class 100 cleanroom, ensuring zero oxidation and particle intrusion. Ultra-high-purity argon purge gas maintains internal cleanliness during fusion, and each weld is verified through helium leak testing to confirm full penetration.
Is orbital welding the right solution for you?
Before getting into the orbital welding process, it’s important to assess whether it’s the right solution for your project. Answer these questions:
- What type of tubing does your project use, and does it need to remain the same?
- What is the size and diameter of the tube to be welded?
- How many fittings are needed to complete the delivery system of tubing?
- How much space is required between weldments and tube fittings?
- What kind of tube finishing is needed?
- Does Axenics have the right head for the orbital welding machine in-house, or is a custom head required?
Ideal industries for ultra-clean welding
Ultra-clean welding is a necessity within industries where zero contamination and superior weld quality are non-negotiable. While chemical manufacturing and alternative energy are prime examples, other sectors—such as semiconductors, medical devices and life sciences—also regularly demand high-purity welds. Orbital welding plays a pivotal role in providing these industries with the cleanest welds possible, significantly reducing the risk of micro-contamination. Bacterial contamination, for example, is a significant concern for these sectors.
The Class 100 cleanroom manufacturing advantage
Our world is filled with particles of all sizes. They come from everywhere: old skin cells that flake off, working machinery that creates grit from the friction when metal parts rub together, or dried lubrication on bearings and crankshafts that form into dust. For component manufacturers, especially those in the semiconductor industry, particulates the size of 0.5 mm or larger can get onto microcircuits and ruin their functions. Since microcircuits can be smaller than dust when fabricators create them on silicon wafers, even the smallest impurity can become a costly mistake.
Axenics’ cleanroom manufacturing protocols include tool pre-cleaning, vacuum maintenance, and continuous particle monitoring. Each facility is audited annually and recertified to maintain ISO 5 standards, giving OEM clients documented assurance of environmental control.
Airborne particle counts are measured hourly using calibrated sensors that verify compliance with ISO 14644-1 and -2 standards. Differential pressure readings are monitored continuously to maintain positive pressure across clean zones. Results are recorded and stored with each project’s documentation package for complete traceability.
To achieve welds with zero contamination, metal tubing weldments must be completed in a high-purity, particle-free Class 100 cleanroom environment. Axenics boasts two cleanrooms, which are the perfect setting for the orbital welding process. A proprietary cleaning process is employed, including the use of 18 megaohms (MΩ) of deionized water to thoroughly clean each piece of tubing.
Moreover, our welders wear special Class 100 cleanroom manufacturing suits to prevent any contamination from their clothing entering the tubes, and all tools undergo rigorous cleaning procedures before entering the space. Ultra-high purity argon gas is continuously flowed through the inside of the tubing and the welding torch to prevent oxidation, ensuring the highest weld purity levels are maintained. Maintaining gas and fluid cleanliness is essential, as even the smallest impurity can compromise the integrity of the entire system.
Orbital weld testing
The pursuit of perfect welds doesn’t end with the welding process itself. Axenics adheres to stringent quality control measures, including orbital weld testing. Every weld undergoes sight confirmation for full penetration, ensuring the highest weld quality. Additionally, welds may be subjected to helium spectrometer tests, and some may even require x-ray radiographic testing, depending on code or customer requirements. Destructive testing is also an option for critical applications.
Each weld is documented through a weld map that includes material heat codes, operator ID, and inspection results. Helium leak test data and X-ray certifications are stored electronically for every production lot. This traceability ensures every component can be verified back to its source material and weld parameters, supporting regulatory audits and OEM quality programs.
Optimizing and economizing orbital welding
Getting around the conventional limitations of automated pipe welding processes is where orbital welding shines. It’s not only the cleanest way to join tubes, flanges, elbows and joints across various applications and industries, but it’s also highly efficient.
Precision plastic welding enhances manufacturing
Thermoplastic welding plays a crucial role in extending the lifespan of production systems for semiconductor chip manufacturers. The bond created through plastic welding strengthens the thermoplastic material, reducing the risk of leaks, fissures or other faults. Axenics offers precision welding and bending of thermoplastic pipe that seamlessly integrates into liquid and chemical delivery systems.
Semiconductor chip producers, for example, require the safe transportation of potentially caustic chemicals. Plastics inherently resist corrosion better than most metals, making plastic pipe the ideal choice for maintaining the safety and reliability of production systems and end products.
Thermoplastic welding in cleanroom manufacturing
Axenics also performs thermoplastic welding and bending in cleanroom conditions using PFA, PVDF, and PTFE. These materials resist corrosion and chemical attack, making them ideal for chemical-handling systems and gas-delivery assemblies. Forming and welding plastics in a Class 100 environment ensures leak-free joints and eliminates particulate contamination, extending system life in semiconductor and biopharma facilities.
Each thermoplastic assembly undergoes surface cleaning with deionized water rated to 18 megaohms, followed by air drying in a filtered environment. This preparation removes ionic residues that can compromise performance in semiconductor or biopharmaceutical systems. Cleanroom conditions ensure dimensional stability, chemical resistance, and zero particulate transfer during welding and testing.
Industries demanding high-purity welds
While high-purity welding benefits any industry, specific sectors mandate its use due to the critical nature of their applications. The semiconductor, medical device and pharmaceutical industries lead the pack. Here’s a closer look at why high-purity welding is vital in these fields:
Semiconductor manufacturing
Semiconductor cleanroom manufacturing entails the highest levels of precision and purity. The slightest contamination can result in defective microchips, leading to costly production delays and product failures. High-purity welding ensures that no contaminants compromise the semiconductor manufacturing process.
Medical device production
The medical device industry prioritizes patient safety above all else. High-purity welding is essential for manufacturing medical devices, as any impurities could potentially harm patients. Clean, precise welds are critical to the success and safety of medical devices.
Pharmaceuticals and life sciences
In the pharmaceutical and life sciences sectors, product purity is paramount. High-purity welding ensures that the drug manufacturing and research process remains uncontaminated. The clean welds prevent any foreign substances from entering the product, ensuring its efficacy and safety.
Contracting Cleanroom Expertise
Having a class 100 cleanroom for your component manufacturing processes doesn’t require you to change your present manufacturing layout. Instead, you can contract tube welding and tube bending services from an experienced contract manufacturing company like Axenics.
By having Axenics perform all of the testing, inspecting and certification processes, you can also lower overall production costs and eliminate testing and inspections at your location. Lead time is a major concern in the component manufacturing field right now. Axenics keeps many standard components in inventory on a regular basis.
Many OEMs do not have the space for a class 100 cleanroom. Rather than bring your production to a halt when cleanroom welding or bending tasks arise, consider outsourcing to us.
Benefits of outsourcing high-purity cleanroom manufacturing
When it comes to high-purity contract manufacturing, outsourcing is often the most practical and cost-effective solution. Here are some key benefits:
Expertise and experience
Outsourcing to a specialized high-purity contract manufacturer such as Axenics provides access to a wealth of expertise and experience. Axenics’ team of engineers and technicians is highly skilled in working with high-purity materials in a cleanroom environment, ensuring the highest quality.
Cost savings
Investing in the necessary equipment, training and cleanroom environment to perform high-purity welding in-house can be prohibitively expensive. Outsourcing allows businesses to access these capabilities without the upfront costs, resulting in significant cost savings.
Scalability
Outsourcing provides the flexibility to scale production as needed. Whether you have a small batch or a large production run, a high-purity contract manufacturer can accommodate your requirements.
Immediate cleanroom access
Skip the capital expense and delay of building ISO-certified facilities. Axenics provides ready-to-use cleanroom manufacturing for prototypes or full-scale productions.
Verified quality
Each weld and assembly is helium-leak-tested and documented to SEMI and ASME standards.
Reduced validation burden
Outsourcing cleanroom operations minimizes in-house inspection requirements and accelerates product qualification.
Focus on core competencies
By outsourcing high-purity contract manufacturing, businesses can focus on their core competencies and strategic goals while leaving the manufacturing process to experts. This allows for greater efficiency and innovation in other areas of the business.
Compliance and quality assurance
High-purity contract manufacturers like Axenics adhere to strict quality control standards and industry regulations. This ensures that products meet the highest standards of purity and quality, reducing the risk of defects and regulatory issues.
The Axenics advantage
Why choose Axenics for your high-purity contract manufacturing needs? Here are some compelling reasons:
Proven track record
With nearly 40 years of experience, Axenics has a proven track record of delivering high-quality, high-purity products to a wide range of industries.
State-of-the-art facilities
Axenics operates a cleanroom environment equipped with the latest technology and equipment for high-purity welding and assembly.
Skilled team
Our team of engineers, technicians and welders is highly trained and experienced in working with high-purity materials and in a cleanroom environment.
Custom solutions
Axenics specializes in custom solutions, working closely with clients to design and manufacture products that meet their exact specifications and requirements.
Compliance
We adhere to stringent quality control standards and industry regulations to ensure that our products meet the highest standards of purity and quality.
Scalability
Whether you need a small batch or a large production run, Axenics can scale production to meet your needs.
Maintaining customer loyalty
Your customers are well-informed and actively involved in the buying process, seeking detailed information about specific products and manufacturing processes. To thrive in this environment, businesses must focus on building and maintaining customer loyalty through education, social media engagement and personalized customer service.
At Axenics, we believe that excellent customer service begins by choosing and developing the right components to handle specific processes in chemical manufacturing. We take pride in collaborating closely with design and engineering teams to custom-build systems that meet exact specifications and provide efficient solutions. Our product range encompasses high-purity plastic piping systems, secondary containment boxes and more— all rigorously tested for superior quality and functionality.
Navigating industry trends
The chemical manufacturing industry, for example, experiences trends that can either fade quickly or exert a lasting influence. Identifying emerging trends and staying ahead of the curve is vital for industry leaders. Axenics specializes in problem-solving, tackling complex challenges on a daily basis.
The future of high-purity cleanroom manufacturing
As industries continue to demand higher levels of purity and precision, high-purity contract manufacturing will play an increasingly vital role in meeting these requirements. Growth in hydrogen-energy systems, microelectronics, and advanced medical devices continues to expand the scope of cleanroom manufacturing. To meet these needs, Axenics invests in hybrid orbital-welding equipment, and process automation that enhance precision while reducing waste.
Facility improvements include energy-efficient HEPA systems, modular cleanroom expansions, and variable airflow control that reduce energy consumption while maintaining ISO 5 purity. Axenics also monitors filter life and airflow efficiency to optimize environmental performance and sustainability.
Continuous improvement also extends to environmental control and personnel practices. Axenics maintains validated gowning and entry protocols designed to eliminate particles from personnel and clothing, ensuring Class 100 (ISO 5) standards are upheld even as production scales.
Emerging sustainability goals also influence cleanroom operations. Axenics explores energy-efficient filtration and waste-reduction initiatives that align purity with environmental responsibility.
Axenics remains committed to staying at the forefront of technological advancements and industry trends to continue providing innovative solutions to its clients.
In a world where precision, purity and cleanliness matter more than ever, Axenics stands as a trusted partner for high-purity contract manufacturing. With state-of-the-art facilities, a skilled team and a commitment to quality, Axenics delivers solutions that meet the rigorous demands of industries such as semiconductor manufacturing, medical device production and life sciences. When it comes to high-purity welding and assembly, Axenics is a name you can trust.
For more information on our high-purity contract manufacturing services and how we can help you achieve your manufacturing goals, contact Axenics today.
Frequently Asked Questions About Cleanroom Manufacturing
When it comes to high-purity contract manufacturing, outsourcing is often the most practical and cost-effective solution. Here are some key benefits:
What is Class 100 cleanroom manufacturing?
Class 100, also known as ISO 5, defines an environment where no more than 100 airborne particles measuring 0.5 microns or larger are present in each cubic foot of air. Maintaining this level of cleanliness requires continuous filtration, pressure control, and carefully managed entry procedures. At Axenics, every process, including metal tube bending, orbital welding, and thermoplastic assembly, takes place in certified Class 100 cleanrooms to protect products from contamination and ensure consistent high-purity results.
Why is cleanroom manufacturing critical for semiconductors?
Semiconductor production depends on contamination-free conditions because even a single particle can damage wafers or reduce yield. Cleanroom manufacturing prevents these issues through HEPA-filtered airflow, precise humidity control, and ultra-high-purity gas delivery. Axenics’ cleanroom operations meet SEMI and ASME standards, ensuring oxidation-free welds, accurate geometry, and reliable performance.
What other industries rely on cleanroom manufacturing?
In addition to semiconductors, industries such as medical devices, pharmaceuticals, life sciences, and alternative energy all depend on cleanroom manufacturing. These applications require sterile, particle-free pathways for gases and fluids, along with full documentation that verifies purity and performance throughout production.
Can cleanroom manufacturing reduce costs?
Yes. Outsourcing to Axenics eliminates the capital and maintenance costs of building in-house cleanroom facilities. Our equipment, trained technicians, and certifications are already in place, allowing our customers to focus on innovation and production. Using Axenics’ established processes and standard components also reduces validation time, rework, and total project costs.
How does Axenics ensure cleanroom compliance?
Cleanrooms are audited and recertified each year to ISO 5 standards. Continuous air monitoring, validated gowning procedures, and controlled material handling maintain consistent purity. Every weld, bend, and assembly is documented, inspected, and tested before leaving the cleanroom to guarantee verified, contamination-free results.