Control Bioburden & Particulates
Medical device manufacturing requires rigorous control over both non-viable particles and viable microorganisms. Explore the critical control points below.
ISO 13485 Compliance
Quality ManagementMeeting regulatory requirements for Medical Device Manufacturing (QMS) through validated environments.
Designed for Sterility Assurance
We design workflows that minimize cross-contamination risk, from raw material entry to final sterile barrier packaging.
Material Decontamination
Material airlocks (MAL) with UV or wipe-down stations to reduce bioburden before entry.
Clean Assembly (ISO 7)
Positive pressure zones for manual assembly, bonding, and inspection of devices.
Sterile Packaging (ISO 5)
Critical zone sealing of Tyvek pouches to ensure the sterile barrier is intact.
Medical Device Grades
Select a class to understand its application in medical device manufacturing.
Implant Handling (ISO 5)
Critical zone for exposing bacterial-sensitive implants before packaging.
From Catheters to Orthopedics
Clean environments designed for every stage of the medical product lifecycle.
Catheter Assembly
Precision assembly of tubing and guidewires under microscopes.
Orthopedic Packaging
Packaging of knee and hip implants after cleaning and passivation.
IVD Test Kits
Humidity-controlled environments for reagent filling and strip assembly.
Clean Molding
HEPA-shrouded molding machines for medical component production.
Hygienic Hardware
Flush Wall Systems
Zero-ledge panels to prevent dust accumulation.
Flush Windows
Double-glazed, flush-mounted for easy wipe-down.
Vinyl Flooring
Heat-welded seams with coved bases for asepsis.
Decon Pass Box
Active HEPA purge to clean items upon entry.
Build Your Medical Cleanroom
Expert design and build services for ISO 13485 compliance.
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