Design and Commercial Support for Advanced Single-Use Medical Devices

1. Single-Use Bioprocess Systems (2D/3D Bags up to 3000L)

​

These high-performance fluid management systems are designed for critical pharmaceutical and biomanufacturing environments. Engineered under ISO 13485 and ISO 14971 standards and manufactured in ISO Class 7 cleanrooms, the product range includes:

• 2D and 3D single-use bags customizable in capacity, port configuration, and connection types

• Constructed with high-barrier, five-layer coextruded PE films (with EVOH layer) ensuring low extractables/leachables, clarity, and oxygen protection

• Qualified through USP, ASTM, and Ph. Eur. testing protocols including:

  • Extractables & Leachables studies (USP 1665, USP 665, BPOG)

  • Gamma irradiation and transport resistance

  • Bubble leak tests and tensile strength validations

  • Endotoxin levels < 0.25 EU/mL (USP 85)

  • Sterility (Ph. Eur. 2.6.1), Particulate Matter (USP 788, 790)

• Integrated solutions include ports, platinum-cured silicone tubing, and aseptic connectors, all vacuum-sealed and barcoded for traceability

These systems are designed to integrate seamlessly into stainless-steel vessels or closed-loop production systems and are adaptable for biopharma, vaccine production, and ATMP manufacturing.

​

​

2. Parenteral and Enteral Nutrition Bags

​

Designed for hospital and home care use, these medical-grade flexible containers comply with international regulatory requirements such as FDA 510(k), CE Marking, ISO 13485, and MDSAP.

Key features include:

• EVA, EVA-UV, and Multilayer films offering visibility, UV protection, and low oxygen permeability for nutrient stability

• Customizable configurations from 150mL to 5000mL, including single and multi-chamber bags

• Compatibility with major compounding systems and infusion pumps

• Available with male/female connectors, infusion sets, spike ports, drip chambers, and injection sites

• Full biocompatibility certification per ISO 10993-4/5/10/11/18 and functional tests per ISO 15747

Special attention is given to pediatric use, light-sensitive preparations, and sterile drug compounding environments.

​

​

Added Value

​

The partner benefits from a vertically integrated, Industry 4.0-ready facility with in-house engineering, traceable manufacturing, and a strong focus on cleanroom compliance and digitalized quality control. Passy Business provides strategic advisory, commercial development, and go-to-market support in selected international territories.

This project reflects our ongoing commitment to helping manufacturers of innovative medical solutions reach new markets with regulatory readiness, technical credibility, and a clear value proposition for healthcare providers.