Looking forward: Modular concepts for PHARMAWASSER in contract manufacturing

PW-System Werner GmbH, modular expandable (©Werner GmbH 2018)

"Water treatment and distribution systems should be designed, constructed, and maintained in such a way that water of suitable quality is reliably produced. They should not be operated beyond their intended capacity" (EG-GMP Guideline (2010), Annex 1 Manufacturing of sterile medicinal products).

An oversized pharmaceutical water system inevitably causes long downtimes, which often lead to microbiological contamination and unnecessary operating costs. The demand for pharmaceutical water is often not precisely calculable at the time of preparing the specifications, and a "safe margin" is usually applied, i.e., a pharmaceutical water system is tendered with a capacity that exceeds the actual need.

The solution: A pharmaceutical water system should be modular in design and thus expandable accordingly. This requirement is especially critical for contract manufacturing organizations.

Werner GmbH has successfully applied this approach in many cases.

Werner already designs the basic system with an expansion option to increase capacity by an additional 50 to 100%.

The basic design for an expandable, pre-qualified pharmaceutical water system is divided into the following stages:

- Serial deionization system (85°C) with sufficient capacity for final expansion
- TS-PLUS recirculation system for selective thermal sanitization of deionization and reverse osmosis, optional membrane degassing and CEDI
- Reverse osmosis expandable in steps through additional membrane elements without changing the overall system dimensions
- Membrane degassing, expandable at any time with an additional module
- Electro-ionization, expandable at any time with an additional module

The modular Werner systems have been operating successfully for over 7 years to the full satisfaction of the individual plant operators. The first expansions with an additional reverse osmosis membrane element were implemented after just 12 months in some cases, and all further expansion stages, which have not yet been realized, will ensure the long-term supply of purified water as needed.