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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.

Service Process

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.

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool

"Great expertise and people!"

Rick Chen
Rick Chen

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell

"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

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool

"Great expertise and people!"

Rick Chen
Rick Chen

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell

"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

"Great customer service! Paul is super dedicated."

Mo Amin
Mo Amin

"Amazing business and amazing person to work with.Paul and I grew up together he has always had attention to detail in everything he has ever done,my company has used him a couple times now and are so pleased with the outcome I would recommend the company to anyone, once again..."

Kevin Nattress
Kevin Nattress

"Had a Great to work with Paul and it has been great! Has a plethora of knowledge and was great to learn from."

Landen Pool
Landen Pool

"Great expertise and people!"

Rick Chen
Rick Chen

"driven with details ... Very impressive"

Lawrence Dathe
Lawrence Dathe

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

Matt Maskell
Matt Maskell

"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
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 of Evōk Polymers

Paul Dathe

Founder

Paul Dathe founded Evōk Polymers with a passion for helping medical device and pharmaceutical companies manufacture the highest quality injection molded components. With over 25 years of specialized experience in engineering precision plastic parts, Paul brings deep expertise in solving complex challenges unique to cleanroom injection molding and healthcare applications. Prior to founding Evōk, Paul served as senior mechanical engineer for Entegris, where he led development of a $40 million product line of ultra-clean liquid delivery systems used in semiconductor and flat panel applications—experience that directly translates to contamination-sensitive medical manufacturing. At Caliber Products, he designed and launched 13 new products, growing sales 540% while maintaining 100% client retention. Paul's background also includes product development roles at Boston Scientific, where he gained intimate knowledge of medical device regulatory requirements and quality systems. He holds four U.S. utility patents, is a Six Sigma black belt certified in process optimization, and earned his Bachelor of Science in Mechanical Design from Bemidji State University. Paul is a member of the Allied Executives Business Leadership Peer group and the Institute of Packaging Professionals, staying current with industry best practices in medical manufacturing.

Jason Weber

Industrial Designer

Jason is a seasoned industrial designer with a passion for creating innovative and functional medical products that prioritize both form and human factors. His design philosophy is deeply influenced by his multi-generational household perspective, where living with his wife, two sons, and mother has nurtured an innate empathy crucial for healthcare product development. This unique viewpoint allows Jason to keenly observe human behavior and ergonomic needs—essential skills when designing medical devices that must be intuitive for healthcare professionals and patients alike. Jason's approach to cleanroom-compatible product design balances aesthetic appeal with manufacturability in controlled environments, ensuring that components meet strict contamination control requirements while remaining user-friendly. His ability to translate clinical needs into manufacturable designs makes him instrumental in developing medical device components that succeed both in the cleanroom and in real-world healthcare settings. In his leisure time, Jason enjoys indulging in his passions for cooking, gaming, and unwinding—activities that keep his creative problem-solving skills sharp.

Shawn Monitor, Sr. Industrial Designer at Evōk Polymers

Shawn Monitor

Sr. Industrial Designer

Shawn brings unparalleled expertise in prototyping and visualizing complex medical device components, making him invaluable for cleanroom injection molding projects where precision and contamination control are paramount. Over two decades, he has been a vital creative force on advanced product development initiatives, with particular strength in graphically and physically communicating evolving design concepts for healthcare applications. Shawn's ability to build complex mechanical and visual prototypes in various materials—including medical-grade plastics—allows clients to validate form, fit, and function before committing to expensive cleanroom-qualified production tooling. He creates photorealistic renderings using Otoy OctaneRender® that help medical device teams visualize final products, and develops technical diagrams with Adobe Creative Cloud to communicate manufacturing requirements for GMP environments. Shawn's involvement in pre-molding design reviews has significantly reduced risk in large-scale medical manufacturing projects by identifying potential contamination risks and assembly challenges early in development. His research spans consumer products to biotech and medical facilities, giving him unique insight into healthcare manufacturing requirements. Shawn holds several patents and, outside of work, practices photography while enjoying the vibrant Twin Cities live music scene.

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

Daniel D. Hoyt, Ph.D.

Business Development Manager

Dr. Daniel Hoyt's expertise in system and process design, coupled with his ability to cultivate strategic partnerships, makes him essential to Evōk's mission of transforming cleanroom injection molding for medical and pharmaceutical clients. His passion for innovation and collaboration shines through in building Lean Partnership-Based Organizations that empower healthcare manufacturers—from emerging medical device startups to established pharmaceutical companies—to bring life-saving products to market efficiently. At Evōk, Daniel leads initiatives that challenge traditional norms in cleanroom part design, prototyping, validated tooling, and GMP-compliant manufacturing. His vision extends beyond disruption; he aims to build a community centered on continuous improvement, mutual benefit, and genuine partnership—values critical in the highly regulated medical device industry where trust and transparency are paramount. Daniel's commitment to transforming industry standards aligns perfectly with the rigorous quality requirements of healthcare manufacturing. Under his leadership, Evōk establishes new benchmarks for collaborative success in contamination-sensitive applications. His proficiency as a facilitator, public speaker, teacher, and coach—combined with his talent for team building and mentorship—helps medical device clients navigate complex regulatory pathways while optimizing manufacturing efficiency.

Natalie Weber, Operations Officer at Evōk Polymers

Natalie Weber

Operations Officer – LIV

Natalie brings a unique perspective to cleanroom operations management by harmoniously blending product design expertise with environmental consciousness—increasingly important as medical device manufacturers face pressure to balance patient safety with sustainability goals. As a dedicated professional in product design and management, she possesses an innate curiosity and discerning eye for innovation in healthcare manufacturing. Having been immersed in design principles since childhood, Natalie grasps the profound impact medical products wield not only on patient outcomes but also on environmental stewardship. This awareness, coupled with her education in sustainability, propels her commitment to infusing eco-conscious practices into cleanroom operations while maintaining the stringent contamination control standards required for medical device manufacturing. Under the guidance of seasoned professionals, Natalie delves deeply into the intricacies of GMP-compliant production, eagerly exploring materials, manufacturing techniques, and cleanroom technologies while remaining mindful of their ecological footprint. Her role extends beyond ensuring operational efficiency; she aspires to help shape a future where medical device manufacturing seamlessly intertwines regulatory compliance, quality excellence, and environmental responsibility—leaving a positive legacy for healthcare innovation.

Julie Young, Accounting and Finance Manager at Evōk Polymers

Julie Young

Accounting and Finance Manager

Julie has been the financial backbone of Evōk since its inception, bringing meticulous attention to detail crucial for managing the complex cost structures inherent in cleanroom injection molding for medical and pharmaceutical clients. As an experienced financial manager, she brings thorough understanding of accounting principles specifically tailored to manufacturing operations that must maintain strict documentation for FDA audits and ISO compliance. Julie excels in organizing and categorizing transactions related to validated materials, cleanroom certification costs, and quality system expenses—ensuring transparent pricing structures that medical device clients depend on for budgeting and regulatory submissions. Her expertise in reconciling accounts and producing clear financial reports enables Evōk to provide the upfront cost transparency that healthcare manufacturers need when evaluating cleanroom injection molding projects. Julie's proficiency in accounting software ensures streamlined processes and timely delivery of financial documentation supporting certificate of conformance packages and batch record traceability. Committed to professionalism and confidentiality—essential in the competitive medical device industry—she provides reliable financial services that support both operational excellence and regulatory compliance. Julie ensures all vendors, including specialty material suppliers and calibration service providers, are paid punctually to maintain the uninterrupted cleanroom operations critical for medical manufacturing.

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 You can also send us a quick email at