● ISO 13485 Certified Cleanroom Assembly

Precision Assembly of Medical Disposables at Scale

We are a contract manufacturer specialized in high-volume assembly of respiratory disposables — swivel catheter mounts, HME filters, L-connectors, water traps and custom connection parts — under ISO 13485 cleanroom conditions.

Manufacturing Facility
1M+Units assembled / year
ISO 13485Quality management
ISO 6Cleanroom class
5+Product
Product Portfolio

Respiratory Disposables We Assemble

Core expertise in respiratory circuit components and connection parts, manufactured to strict dimensional and biocompatibility standards.

Swivel Catheter Mount

Flexible tracheal connectors with 360° swivel joint and integrated suction port.

  • 15M/15F & 22M/15F configurations
  • Double swivel option
  • Sealed suction cap

HME / Breathing Filter

Heat and moisture exchange filters with high bacterial/viral filtration efficiency.

  • BFE/VFE > 99.99%
  • Adult / pediatric variants
  • Low dead space

L-Connector

90° elbow connectors for breathing circuits with tight-fit conical ports.

  • Straight, angled, double-swivel
  • ISO 5356 taper
  • Sealed cap options

Water Trap

Inline moisture collection chambers for ventilator and anesthesia circuits.

  • Autoclavable & disposable
  • Leak-tight quick drain
  • Transparent bowl
Y

Y-Piece & Connectors

Circuit branching and inline connectors for inspiratory/expiratory limbs.

  • 22M/22F taper
  • Optional gas sampling port
  • Smooth internal flow path

Custom Connection Parts

Bespoke assembly of customer-supplied or co-developed connection components.

  • Design-for-manufacturing support
  • Private-label packaging
  • OEM & ODM
Services

End-to-End Contract Assembly

From incoming component inspection to final sterile packaging — one accountable partner.

Cleanroom Assembly

ISO Class 7 cleanroom assembly of respiratory disposables at production volumes.

1Component IQC2Bonding & fitting3Leak test4Labeling

Precision Manufacturing

Ultrasonic welding, solvent bonding and pressure-fit assembly of medical-grade plastics.

1Tooling setup2Process validation3In-line SPC4FAI report

Packaging & Sterilization

Blister and pouch packaging with validated EO / gamma sterilization partners.

1Primary packing2Sealing validation3Sterilization4Batch release

Quality Control & Testing

100% functional leak testing plus AQL sampling for dimensional & visual criteria.

1Incoming QC2In-process checks3Leak/flow test4Final release
Certifications & Compliance

Regulatory-Grade Quality System

Our processes are aligned with the global standards required for medical disposables.

ISO 13485Medical QMS

ISO 13485

Quality management system

CE / MDREU 2017/745

CE Marking

EU MDR compliant

GMPGood Mfg. Practice

GMP

Cleanroom & process discipline

ISO 9001Quality Management System

Quality Management System

Quality management system

Manufacturing Facility
About Misa Global

Your Cleanroom Partner for Respiratory Disposables

We combine cleanroom infrastructure, validated processes and an experienced quality team to deliver high-volume medical disposable assembly for OEMs and distributors worldwide.

  • Dedicated ISO Class 7 assembly lines
  • Traceability from raw component to shipped batch
  • Design-for-manufacturing collaboration
  • Rapid scale-up for new product introductions
Get in Touch

Let's Discuss Your Project

Share your specifications and target volumes — we'll respond with a feasibility assessment within 2 business days.

Phone

+90 .....

Email

info@misaglobalsolutions.com

Facility

IZMIR, Türkiye

Send an Enquiry →