Cleanroom Tent CAPE® makes pharmaceutical manufacturing more flexible

New development with load-bearing structure, textile filling, main room, lock, and air conditioning. © Fraunhofer IPA / Photo: Rainer Bez

A research team led by Frank Bürger and Viola Hoffmann from Fraunhofer IPA has developed a high-purity and flexible production environment for pharmaceutical manufacturing in collaboration with Bayer AG. All requirements of the pharmaceutical industry were taken into account. The basis was a patented concept for tent-like cleanrooms, known as CAPE®.

The goal of the researchers was to create a scalable pharmaceutical production environment that meets the highest standards of purity and flexibility. Ensuring compliance with strict particulate and microbiological requirements was particularly important. Key factors were hygienic design and the selection of suitable materials.

The new production environment consists of a supporting structure and a textile cover that includes a main area, an airlock, and a clean air supply for positive pressure operation. Using combined filter and fan systems, the project team implemented an air treatment system that allows adjustable proportions of recirculated and outside air. The team installed the prototype in a climate-controlled Bayer manufacturing hall. Initial test results confirm the suitability of the new development for pharmaceutical production.

Tests show: All requirements met

In tests, the project team demonstrated compliance with GMP Class B regarding particulate air cleanliness, microbial count, and requirements for hygienic design, tightness, pressure levels, and the chemical and microbiological stability of the materials used. Additionally, the quick expandability of the supporting structure and textile cover allows for demand-driven scaling of production areas. The textile components can be reprocessed or disposed of depending on the application.

Bayer AG is currently examining which production steps in the field of biological development could, in the future, be manufactured within the CAPE® system under GMP cleanroom requirements C and D as part of regulatory approvals. The new development can also be used by other pharmaceutical companies in accordance with Fraunhofer IPA.