Life Science

Stryker Osteosynthesis AG – Cleanroom Planning and Ventilation Concept for Medical Technology Production

The Stryker Group is one of the world’s leading suppliers of orthopedic and medical technology products. IE Life Science was responsible for the Planning and Execution of a redesigned packaging area and the expansion of production to include a new cleanroom.

More Performance and Better Packaging – in the New Cleanroom

Project

Redesign of the packaging area and Planning and Execution of a cleanroom expansion

Client

Stryker Osteosynthesis

Key Data

Planning & Execution
IE Life Science
Construction Period
7 months
Cleanroom Investment Volume
CHF 1.15 million
Building Refurbishment Investment
CHF 2.85 million
Cleanroom Classes
ISO 6/7/8

Working Together for Project Success

Services provided by IE Group

  • Planning and Execution of a new cleanroom
  • Adaptation of existing process technology
  • Optimisation of personnel and material flows
  • Development of an energy‑efficient ventilation concept
  • Phased relocation of production areas during ongoing operation
  • Holistic planning approach covering production and process steps

Challenges & Solutions

Implement a GMP‑Compliant ISO 7 Cleanroom With Integrated ISO 6 (LF) Area

IE Life Science developed a sophisticated ventilation concept that reliably supplies both cleanroom classes while operating in an energy‑efficient manner. The GMP‑compliant cleanroom meets all regulatory requirements and, at the same time, supports stable and efficient production processes.

Phased Conversion and Relocation of All Production Areas During Ongoing Operation

Based on a detailed phasing concept, IE Life Science coordinated the step‑by‑step relocation of all production areas. Careful planning of interim states and close coordination with the operating team ensured that the conversion was completed with only minimal impact on ongoing production.

The Project in Detail

The Stryker Group is one of the world’s leading suppliers of orthopedic and medical technology products. At its Selzach site, the medtech company manufactures and packages specialized implants and external fixators. Due to continued growth, the entire packaging area had to be redesigned and expanded to include an additional cleanroom. IE Life Science acted as  general planner and coordinated the phased relocation of the various production areas in cooperation with a general contractor.

The Challenge

Rising production volumes required an urgent reorganization of material and personnel flows. In addition, the available space for order picking and shipping of MedTech products was no longer sufficient. Process technology had to be upgraded, and ventilation planning had to be realigned to comply with strict cleanroom tolerance requirements. The redesign and expansion had to be carried out directly adjacent to the existing ISO 6/7 cleanroom and during ongoing operation. These requirements were further intensified by limited space as well as tight time and cost constraints.

Key Success Factors

When planning the new GMP‑compliant ISO 7 cleanroom with an integrated ISO 6 (laminar‑flow) area, the experts at IE Life Science drew on their extensive experience in operational, process and logistics planning. In joint workshops, a functional, future‑proof and holistic zoning concept was developed. This approach enabled the integration of an energy‑efficient, independently controlled cleanroom with minimal intervention in existing structures. In addition, circulation areas were significantly reduced through targeted optimization of production and process workflows.

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