Google Icon

Cleanroom Injection Molding Services for Medical & Pharma

Evōk Polymers delivers ISO-certified cleanroom injection molding tailored for medical devices and pharmaceutical applications. Our controlled-environment manufacturing ensures contamination-free precision components that meet stringent regulatory standards. With 25 years of expertise in ultra-clean production and white-glove service, we transform your critical healthcare designs into reliable, compliant parts—from prototype to high-volume production.

Technicians working in ISO-certified cleanroom manufacturing medical device components

Our Cleanroom Injection Molding Services

Comprehensive ISO-certified cleanroom manufacturing solutions for medical devices and pharmaceutical applications, from prototype to production.

Medical Device Component Manufacturing

Precision injection molding of FDA-compliant medical device components in controlled cleanroom environments. We manufacture surgical instruments, diagnostic equipment parts, and implantable device components meeting ISO 13485 standards with full traceability and documentation.

Pharmaceutical Packaging Solutions

GMP-compliant cleanroom production of pharmaceutical packaging components including vial caps, syringe parts, inhaler components, and drug delivery systems. Our ISO Class 7 and 8 facilities ensure contamination-free manufacturing with validated cleaning protocols.

Biotech & Laboratory Components

Ultra-clean manufacturing of laboratory consumables, diagnostic test components, and biotech research equipment parts. We specialize in materials compatible with sterilization methods including gamma radiation, EtO, and autoclave processes.

Regulatory Compliance & Documentation

Complete validation documentation, material certifications, and regulatory support for FDA, ISO 13485, and EU MDR compliance. Our quality systems include batch traceability, process validation reports, and change control documentation.

Cleanroom Prototype Development

Rapid prototype services in controlled environments to validate designs before production tooling. We provide both cosmetic and functional prototypes manufactured with the same materials and processes as production parts, ensuring accurate representation of final products.

Material Selection & Testing

Expert guidance on USP Class VI, ISO 10993 biocompatible materials, and pharmaceutical-grade resins. We conduct comprehensive material testing including extractables/leachables studies, biocompatibility assessments, and chemical resistance validation.

Step-by-step cleanroom injection molding process from design to production

Our 5-Step Cleanroom Manufacturing Process

Design for Cleanroom Manufacturing Review

Our engineers review your design for cleanroom moldability, material compatibility with sterilization methods, and regulatory compliance. We optimize part geometry for contamination-free production while ensuring features meet FDA and ISO medical device standards. This phase includes mold flow analysis and DFM recommendations specific to healthcare applications.

Material Selection & Biocompatibility Validation

Cleanroom Prototype & Testing

Validated Tooling & First Article Qualification

GMP Production & Continuous Quality Monitoring

Proven Track Record

Trusted By Industry Leaders

Medical device manufacturers and pharmaceutical companies trust Evōk for contamination-free precision manufacturing.

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

"Evok provided exceptional service! Paul and the studio team demonstrated amazing expertise and professionalism throughout the process. They exceeded expectations with precision and timely execution. Highly recommend for any project requiring top-notch design solutions."

Jason Salveson
Jason Salveson

"Paul is very knowledgeable and passionate regarding all facets of plastics manufacturing."

Matt Maskell
Matt Maskell
The Evōk Difference

Why Choose Evōk Polymers for Cleanroom Injection Molding?

25 years of expertise delivering ultra-clean, FDA-compliant injection molded components for healthcare innovators.

ISO-Certified Cleanroom Facilities

Our validated ISO Class 7 and 8 cleanrooms feature continuous environmental monitoring, HEPA filtration, and documented cleaning protocols meeting FDA and GMP requirements.

Medical Device Expertise

Deep knowledge of FDA regulations, ISO 13485 quality systems, and biocompatible material science gained from serving medical device leaders like Boston Scientific and the pharmaceutical industry.

Full Documentation & Traceability

Comprehensive validation packages including IQ/OQ/PQ protocols, material certifications, batch records, and process capability studies ensuring audit-ready compliance.

Speed to Market with Compliance

Our streamlined NPD pipeline accelerates time-to-market while maintaining rigorous quality standards, helping you meet regulatory milestones without compromising on contamination control.

Meet The Evōk Polymers Team

Healthcare manufacturing specialists dedicated to your success.

Paul Dathe, Founder and Chief Engineer at EVOK Polymers

Paul Dathe

Founder

Paul Dathe founded Evōk Polymers with a singular mission: delivering the highest quality injection molded components at the lowest possible price through proprietary technology and deep industry expertise. With over 25 years specializing in engineering, product design, and solving complex injection molding challenges, Paul brings unparalleled depth to every project. He holds four U.S. utility patents and earned Six Sigma black belt certification, applying rigorous process optimization to mold design engineering. Prior to founding EVOK, Paul led new product development at Caliber Products, launching 13 products while growing sales 540% and expanding from 25 to 144 customers with 100% retention. His responsibilities spanned tooling design, functional assessments, 3D modeling, prototype fabrication, tolerance analysis, and mold flow studies. Earlier, as Senior Mechanical Engineer at Entegris, Paul managed a $40 million product line of ultra-clean liquid delivery systems for semiconductor applications. He began his career at Rollerblade in design and prototyping before serving in senior engineering roles at General Mills and Boston Scientific. Paul earned his Bachelor of Science in Mechanical Design from Bemidji State University with emphasis in rapid prototyping and 3D computer modeling. He's an active member of Allied Executives Business Leadership Peer group and the Institute of Packaging Professionals.

Jason Weber, Industrial Designer at EVOK Polymers

Jason Weber

Industrial Designer

Jason is a seasoned industrial designer with a passion for creating innovative and functional injection molded products. His design philosophy is deeply influenced by his life within a multi-generational household with his wife, two sons, and mother, which nurtures innate empathy and keen observation of human behavior—qualities that translate directly into user-centered design excellence. Jason brings creative vision to EVOK's engineering projects, balancing aesthetic refinement with manufacturing practicality. His ability to understand how people interact with products ensures that every component he designs not only meets technical specifications but also delivers intuitive functionality and ergonomic comfort. Jason's multidisciplinary approach bridges the gap between pure engineering and real-world application, helping clients create products that resonate with end users. Outside the studio, Jason finds inspiration through cooking, gaming, and relaxation, activities that fuel his creative process and problem-solving abilities.

Shawn Monitor, Sr. Industrial Designer at EVOK Polymers

Shawn Monitor

Sr. Industrial Designer

Shawn Monitor has been an instrumental creative force on some of the most advanced injection molded seating and component projects of the last two decades. His particular expertise lies in graphically and physically communicating evolving design concepts and intricate part features through complex mechanical and visual prototypes built in diverse materials. Shawn creates photorealistic renderings using Otoy OctaneRender® and develops professional layouts, diagrams, and logos with Adobe Creative Cloud, providing clients with clear visualization of engineering concepts before tooling commitment. His deep involvement in pre-molding design reviews has significantly reduced risk on numerous large-scale projects by identifying and resolving potential manufacturing issues early in the development cycle. Shawn excels at finding mechanical molded part solutions that can be prototyped and validated prior to expensive production tooling, saving clients time and money while ensuring design intent is maintained. He holds several patents reflecting his innovative approach to injection mold component design. Beyond his professional achievements, Shawn practices photography and enjoys the vibrant Twin Cities live music scene, interests that sharpen his visual communication skills and creative thinking.

Daniel D. Hoyt, Ph.D., Business Development Manager at EVOK Polymers

Daniel D. Hoyt, Ph.D.

Business Development Manager

Daniel brings exceptional expertise in system and process design engineering, coupled with strategic partnership cultivation that sets EVOK apart in the injection molding industry. His passion for innovation and collaboration drives initiatives that challenge traditional norms in part design, prototyping, tooling, and injection mold manufacturing. Daniel's vision extends beyond disruption—he's building a community centered on continuous improvement, mutual benefit, and genuine partnership that empowers small and mid-sized businesses to compete at the highest levels. His leadership focuses on creating Lean Partnership-Based Organizations that optimize engineering processes and deliver sustainable growth. Daniel's proficiency as a facilitator, public speaker, teacher, and coach, combined with exceptional team-building and mentorship abilities, accelerates EVOK's mission to transform industry standards. Under his guidance, EVOK establishes new benchmarks for collaborative engineering success, ensuring clients receive not just technical expertise but strategic insights that drive their competitive advantage in demanding markets.

Natalie Weber, Operations Officer at Evok Polymers

Natalie Weber

Operations Officer – LIV

Natalie is a dedicated apprentice in product design and management who embodies the harmonious blend of creativity and sustainability in injection mold engineering. Possessing innate curiosity and a discerning eye for innovation, she tirelessly explores where design converges with environmental consciousness—bringing fresh perspectives to material selection and dematerialization strategies. Immersed in intangible design principles since childhood, Natalie grasps the profound impact injection molded products can have on the planet, driving her commitment to infusing eco-consciousness into every project facet. Her education in sustainability, combined with hands-on mentorship from seasoned professionals, accelerates her mastery of product design intricacies. Natalie investigates diverse materials, manufacturing techniques, and emerging technologies, always evaluating their ecological footprint and lifecycle implications. Her journey extends beyond creating aesthetically pleasing components—she's shaping a future where injection mold design engineering seamlessly integrates sustainability principles, leaving a positive legacy for generations while meeting demanding performance specifications.

Julie Young, Accounting and Finance Manager at Evok Polymers

Julie Young

Accounting and Finance Manager

Julie Young has been an integral part of Evok since its inception, bringing meticulous attention to detail and thorough financial expertise to the organization. As an experienced accounting professional, she excels in organizing and categorizing transactions, reconciling accounts, and producing clear, concise financial reports that enable informed business decisions. Julie's proficiency in accounting software ensures streamlined processes and timely delivery of financial information, maintaining compliance with all regulatory requirements. Her dedication to professionalism and confidentiality provides the financial backbone that supports Evok's operations and growth. Beyond standard bookkeeping, Julie plays a critical role in vendor relationship management, ensuring all partners are paid promptly and maintaining the trust-based environment that is central to Evok's values. Her reliable financial services support both the team's effectiveness and customer satisfaction by ensuring resources are properly allocated to deliver exceptional injection molding solutions.

Frequently Asked Questions

What are the requirements for clean room injection molding?

Cleanroom injection molding requires ISO-certified controlled environments (typically Class 7 or 8), HEPA filtration systems, continuous environmental monitoring, validated cleaning protocols, trained personnel in cleanroom garments, and documented quality systems meeting FDA and GMP standards. Equipment must be cleanroom-compatible, and materials must have full traceability with certificates of analysis.

What does cleanroom refer to in GMP?

What is the ISO guideline for a cleanroom?

What is cleanroom classification 8?

What is ISO 8 used for?

What is the difference between cleanroom 7 and 8?

Is ISO 8 the same as grade D?

How much does cleanroom injection molding cost compared to standard molding?

Have Questions About Cleanroom Manufacturing?

Our medical device manufacturing experts are ready to discuss your specific regulatory and contamination control requirements.

Ready to Start Your Cleanroom Project?

Share your medical device or pharmaceutical component requirements, and our team will provide a detailed assessment including material recommendations, regulatory guidance, and transparent pricing within 48 hours.

Contact Us Today

For immediate assistance, feel free to give us a direct call at +1 612-991-2001.