For medical device manufacturers, achieving and maintaining precise environmental controls is non-negotiable. An ISO Class 7 cleanroom is a critical component for ensuring product safety, quality, and regulatory compliance. But beyond meeting the standard, finding a manufacturing partner with the proven expertise and facilities to execute flawlessly is key.
The ArcWorks Advantage: Three State-of-the-Art ISO Class 7 Cleanrooms
At ArcWorks, we go beyond simply understanding the ISO Class 7 standards—we embody them. Our 85,000-square-foot facility in Rochester, NY, features three advanced ISO Class 7 cleanrooms, providing a highly controlled environment for your most sensitive manufacturing needs.
Key features of our cleanroom facilities include:
- Optimal Air Cleanliness: Our ISO 7 cleanrooms are engineered to strictly control airborne particles, maintaining purity for applications that require a moderately controlled environment, such as Class I and Class II medical devices.
- HEPA Filtration and Positive Pressure: We utilize high-efficiency HEPA filters and maintain positive air pressure to ensure that particles and contaminants are kept within strict limits.
- Comprehensive Quality Control: Every step of our cleanroom operation is guided by stringent quality control measures and supported by constant in-line inspections. This ensures your products meet the highest standards of purity and safety from start to finish.
ArcWorks: Your Vertically Integrated Manufacturing Partner
When you partner with ArcWorks, you gain more than just access to a cleanroom; you gain a comprehensive manufacturing solution. Our vertically integrated facility streamlines your entire production process under one roof, providing services for the medical device and labware sectors.
Our integrated capabilities include:
Assembly and Kitting:
We specialize in the precision assembly of components, from medical balloons and catheters to surgical equipment.
Packaging and Sterilization Prep:
Our cleanroom services include custom packaging, kitting, heat sealing, and pouch sealing to maintain product sterility and integrity.
In-line Quality Assurance:
Our team performs meticulous quality checks throughout the process to ensure every product is compliant with industry standards.
Flexible and Scalable Production:
With flexible work cells, we can meet immediate production demands and scale with your business as it grows.
Beyond Cleanroom Expertise: A Socially Responsible Business Model
Choosing ArcWorks means partnering with a company that delivers exceptional performance while championing workforce inclusivity. As part of The Arc of Monroe, we provide meaningful career opportunities for individuals with intellectual and developmental disabilities.
Our commitment to a diverse and integrated workforce drives greater innovation and operational excellence, offering you:
- Highly Trained and Motivated Employees: Our dedicated team is passionate about delivering superior results and upholding the highest standard of excellence.
- Reliable and Consistent Quality: Through a responsive, team-based environment, we focus on continuous process improvement to provide reliable and consistent quality for our partners.
- A Values-Driven Partnership: By choosing ArcWorks, you gain a strategic manufacturing partner that aligns with your business objectives while supporting a vital social mission.
Ready to Elevate Your Medical Device Manufacturing?
When precision and contamination control are critical, ArcWorks is the proven partner you can trust. Our three ISO Class 7 cleanrooms and vertically integrated facility offer the speed, quality, and compliance you need to bring your medical devices to market confidently.
Contact ArcWorks today to learn more and discuss your medical device manufacturing needs.