The ASYS Group has completed the design and implementation of a scalable GMP-compliant cleanroom facility for the manufacturer implantcast.
The new facility will support the company’s expansion in orthopaedic implant manufacturing.
The project provides a 240 sqm cleanroom within implantcast’s new Plant 3 facility, aimed at increasing production capacity and aligning operations with stricter international regulatory requirements.
The cleanroom project was delivered by the German-based ASYS Prozess, a subsidiary of ASYS Group, which was responsible for the planning and implementation.
A representative from ASYS Group told Cleanroom Technology that the project took around 14 weeks, from the start of installation through to commissioning and final completion.
The manufacturer implantcast makes products ranging from modular standard orthopaedic implants to complex, patient-specific solutions for tumour reconstruction.
The company required additional cleanroom capacity after its existing facility, operating for around 15 years, reached both spatial and technical limits, with a maximum output of approximately 14,000 parts per week across a three-shift operation.
What is special about the new cleanroom?
The newly installed cleanroom introduces a GMP Grade C environment designed as a scalable intermediate solution.
It comprises 200 sqm of ISO Class 7 cleanroom space and approximately 40 sqm of airlock areas, alongside GMP-compliant wall and ceiling systems and an integrated monitoring system to support continuous validation and stable process conditions.
According to the companies, the new facility is capable of producing up to 30,000 parts per week in single-shift operation, more than doubling previous output levels while reducing operational intensity.
A representative from ASYS also said sustainability measures were incorporated into the cleanroom design.
For this purpose, we use setback operation: the filter-fan units run at a reduced speed to save energy, while room cleanliness and positive pressure are maintained.
The design also enables phased production transfer and supports compliance with international market requirements, including those in the US.
ASYS was responsible for the full project scope, including planning, construction and system integration, delivering a self-supporting cleanroom structure with an integrated technical level above the controlled environment.
“From the very first meeting to the present day [this project had] open and honest collaboration,” said Frank Ansorge, Chief Quality Officer at implantcast.