ASYS Group implements scalable GMP cleanroom concept for implantcast

ASYS PundR Cleanroom Implantcast

ASYS PundR Cleanroom Implantcast

ASYS PundR Cleanroom Implantcast

The ASYS Group has developed and implemented a future-proof, GMP-compliant cleanroom concept for implantcast GmbH. With the new cleanroom area of a total of 240 m², ASYS specifically supports one of the world's leading manufacturers of orthopedic implants in expanding its production capacities and meeting increasing regulatory requirements in medical technology.

implantcast develops and manufactures a continuously growing portfolio – from modular standard implants to highly complex, patient-specific custom-made solutions for tumor treatments. To consistently continue this growth path, the company commissioned ASYS Process and Cleanroom Technology GmbH, a company of the ASYS Group, with planning and implementing a scalable cleanroom that intelligently combines automation, energy efficiency, and GMP compliance.

Initial Situation: Capacity Limits in Production and Cleanroom Technology

The rapid growth of implantcast was reflected both in personnel expansion and in production volume. In addition to significant increases in quality and approval management, research & development, and validation, the existing cleanroom was already reaching its technical and spatial limits:

– Approximately 15 years old cleanroom operating in three shifts
– Maximum production capacity: around 14,000 parts per week
– No further expansion possibilities within the existing infrastructure

To meet future market demands and sustainably secure international approvals, an additional cleanroom with significantly higher performance capacity was required.

Technical Solution: GMP C Cleanroom as a Scalable Intermediate Step

With the new Plant 3, a production hall, implantcast realized a strategic interim solution: enough buffer to continue growing, and at the same time, the foundation for future construction projects.

ASYS Process and Cleanroom Technology took over the complete planning and realization of the cleanroom project:

– A free-standing structure with integrated technical level on the cleanroom
– Total area: 240 m²
   – Of which 200 m² ISO 7 cleanroom area
– About 40 m² airlock areas
– Wall and ceiling systems in GMP design
– GMP-compliant monitoring system
– Designed for continuous validation and reproducible process conditions

The new cleanroom facility is designed for a production capacity of up to 30,000 parts per week in single-shift operation – more than double the previous maximum capacity in three-shift mode. It also enables continuous validation, a phased production relocation, and compliance with international approval requirements, such as for the USA.

Collaboration at Eye Level with High Technical Competence

For Frank Ansorge, Chief Quality Officer at implantcast, besides technical expertise, the way of collaboration was particularly decisive:

– Open communication and transparent coordination
– Solution-oriented planning even for project-specific adjustments
– High execution quality and professionalism on the construction site

“From the first acquaintance to today: an open and honest collaboration.”
Frank Ansorge, Chief Quality Officer, implantcast GmbH

Strategic Milestone for Medical Technology Production

The new GMP C cleanroom represents much more than just an expansion of capacity for implantcast. It forms the technological basis for future growth, international market presence, and the highest quality standards in implant manufacturing.

implantcast would again choose an ASYS Process and Cleanroom Technology cleanroom – a strong signal of trust, quality, and partnership-oriented project work for process-safe production environments in medical technology.