Small and fine – Aqua Purificata "Piccola"

Storage and distribution system with ozonation. ©Werner GmbH 2016.

When it comes to very low water consumption coverage in pharmaceutical production, some system manufacturers often reach their limits. This is partly because, for the construction of small pharmaceutical water systems, custom solutions often need to be developed that cannot be marketed economically due to the low batch sizes.

Specifically developed for these applications, WERNER offers smaller GMP-compliant, pre-qualified pharmaceutical water systems and distribution systems starting from a production capacity of 30 l/h, which can be modularly expanded to cover future demand increases.

Pharmaceutical Water Production “State of the Art”

As with large systems, small WERNER pharmaceutical water systems utilize treatment processes such as deionization, reverse osmosis, membrane degassing, electrodeionization, and ultrafiltration. These can optionally be combined with various sanitization concepts, such as chemical sanitization, thermal sanitization, and ozonation.

FDA 21 CFR Part 11 Compliant System Control

Extensive monitoring technology as well as an “FDA 21 CFR Part 11” compliant system control with audit trail and user management ensure GMP-compliant monitoring and provide maximum operational safety and user comfort.

Hygienic Design

The use of high-quality FDA-compliant plastics such as PVDF-HP welded WNF or stainless steel like 1.4404 or 1.4408 orbital welding ensures that corrosion is avoided and contamination of the purified water by foreign substances is prevented.
A dead-leg-free design, seamless connection techniques, and interior surfaces with a roughness of 0.25 to 0.8 µm are fundamental requirements for hygienic design and significantly contribute to preventing microbial growth.

GMP-Compliant Qualification

The GMP-compliant qualification, including DQ, IQ, and OQ, along with a customized qualification documentation, is also an integral part of smaller WERNER pharmaceutical water systems. This includes, in addition to the Factory Acceptance Test (FAT) at the manufacturer’s site, the on-site qualification with the final Site Acceptance Test (SAT) at the installation location.