In the medical device industry, the quality and cleanliness of components like tubing can make the difference between safe, reliable performance and costly recalls. At ArcWorks, we specialize in producing medical-grade tubing in an ISO 7 (Class 7) cleanroom environment, giving our customers confidence that every length of tubing meets the most stringent contamination and quality standards.
Why ISO Class 7 Cleanrooms Matter for Medical Tubing
ISO Class 7 (also known as Class 7) cleanrooms are controlled environments that limit airborne particles and microbial contamination to defined thresholds. These environments are essential for many medical device processes, where even microscopic contaminants can compromise product safety or sterility.
By manufacturing inside ISO 7 cleanrooms, ArcWorks ensures:
- Low particle counts — the environment is tightly controlled so that particulate levels remain within acceptable limits
- Microbial control — stringent protocols and air filtration reduce the risk of microbial contamination
- Regulatory alignment — many regulatory and customer requirements demand cleanroom-level manufacturing, particularly in medical, labware, and sterile packaging domains
- Consistent product quality — with controlled humidity, airflow, and temperature, product characteristics (e.g. inner diameters, wall thickness, surface finish) remain stable and reproducible
ArcWorks promotes that “Class 7 cleanrooms … play a pivotal role in achieving these standards” in medical device, sterile packaging, labware, and electronics manufacturing.
ArcWorks’ Cleanroom Capabilities & Benefits
Here’s what sets ArcWorks’ cleanroom-enabled medical tubing manufacturing apart:
1. Deep Expertise in Medical Device & Labware Manufacturing
We tailor our cleanroom operations to the unique demands of medical tubing — e.g. compatibility with biocompatible polymers, tight tolerances, clean assembly and inspection — so that our customers’ regulatory, performance, and validation needs are met reliably.
2. Vertically Integrated Production Under One Roof
ArcWorks’ facility brings together multiple processes — cleaning, inspection, assembly, packaging — all within a controlled environment. This vertical integration minimizes contamination risk from inter-facility transfers and accelerates production timelines, helping customers bring products to market faster.
3. Commitment to Quality & In-Process Controls
We maintain rigorous inline inspection and continuous monitoring throughout the cleanroom environment. Quality checks are embedded at multiple stages to detect defects early, maintain traceability, and ensure each tubing segment meets specification.
4. Certified Processes & Regulatory Readiness
Our facility operates under ISO 9001:2015-certified processes, ensuring methodical control over all manufacturing operations. This foundation supports compliance with related medical device standards (e.g. ISO 13485, GMP) and helps customers smoother regulatory audits and product validations.
Medical Tubing Applications Suited for Cleanroom Manufacturing
Because our cleanrooms support tight contamination control, ArcWorks is especially well-suited for:
- Disposable medical tubing (e.g. for IV lines, catheters, fluid delivery systems)
- Labware tubing and connectors that require sterile or low-particle assembly
- Bioprocessing tubing (for example, in pharmaceutical manufacturing)
- Any medical or diagnostic component where regulatory or customer specs demand cleanroom assembly or packaging
Partner with ArcWorks for Cleanroom Medical Tubing
Located in Rochester, NY, ArcWorks is a trusted provider of industrial kitting, labeling, and packaging services, When your project demands ultra-clean, high-integrity medical tubing, ArcWorks is ready to deliver. With a cleanroom-based, vertically integrated, quality-driven operation, we bring consistency, compliance readiness, and speed to your supply chain.
Contact us today to discuss your tubing requirements, request a quote, or arrange a facility tour. Leverage our ISO Class 7 cleanroom advantage to help your medical device succeed in a competitive, heavily regulated market.