Utilities and Highly Purified Media
Pharmaceutical processes depend on various supporting media and utilities, such as CIP, or basic components such as Water-for-Injection (WFI). GEA provides complete lines by integrating plant-wide distribution systems to generate these media into their products.
Water is an important raw material for the production of pharmaceutical liquids, where quality is a prime concern, and an essential ancillary medium for a variety of subordinate processes in the biopharmaceutical industry. To be able to produce the required amount of water at the right quality (USP and Ph Eur), your plant must meet very exacting standards, comply with national and international regulations and undergo stringent control and inspection. GEA plant can fulfil these requirements. Our media and utilities solutions include
- CIP (clean-in-place systems and media) preparation and distribution
- clean steam generation and distribution
- DI water generation and distribution
- WFI generation and distribution
- buffer preparation and storage.
The systems are designed according to FDA and ISPE standards, for example, for sterile design and performance, using high quality GEA vessels for storage. The measurement of the required quality and performance parameters is done using state-of-the-art sensors.
The utility systems are controlled using industrial standard PLC/SCADA units and GEA provides the overall package — from design to manufacturing and testing — including local installation, start-up and qualification support. After sales service and maintenance support complete the overall scope of supply.
Depending on your requirements, we deliver hot or cold storage systems for pure media. With disinfection methods adapted to meet your requirements, the flow velocity and pressure drop of each loop system is designed to comply with cGMP guidelines. Measurement and control instrumentation required to monitor quality parameters (TOC, conductivity, temperature) and flow rates are supplied as standard. In accordance with ISPE guidelines, aseptic design and plant qualification are built in, fulfilling FDA requirements for water and steam systems.Essential Characteristics
- Dead-leg-free design
- Entire system can be completely evacuated and sterilized
- TOC metering technology
- Diaphragm valve technology
- Tubular heat exchangers in DTS design
- Sampling systems
- Sterile filter systems
- Constant flow conditions.
Automation: We will supply the plant with whatever type of operating system you require, from manual to operator-controlled process visualization systems and up to instrumentation and control systems that are capable of controlling several workstations, recording process-relevant data in real-time.
GEA is your knowledgeable partner for the selection and integration of highly purified media production plant and the implementation of storage and CIP/SIP distribution systems. Our experienced process engineers will help you to confidently source a complete solution for your application.