Water for pharmaceutical use
Our expertise allows us to suggest the best design and components for both purified water (PW) or water for injection (WFI) generation and distribution projects . So we design and help our customers to select: the following.
- Processes, instruments and necessary equipment to produce the amount of water required.
- The proper materials for minimizing the risk of microbiological growth and reducing the chemical contamination.
- The right components to comply validation request.
- The cleaning / sanitization equipment – CIP –
- The product tank and distribution loop
- Method of sanitization / sterilization – hot water or UV –
- Central control, monitoring and data transmission
- TOC Reducing, filtration, ozonisation and disinfection methods
Process and technology
- Membrane technology
- Reverse Osmosis
- Electrodeionization
- Ultrafiltration
- Ionic Exchange
Standards to comply
- USP, FDA; CFR 21 Part 11; GMP and GAMP
- Farmacopea Europea
Application
- Water for injection
- Parenteral solutions
- Oral solutions
- Clearing of blisters
- Vapor cleaning
- Cosmetics
Storage and distribution loop
- Design according ASME BPE
- Sanitary tanks and piping
- Certified material
- Certified welding methods
- Certified pasivation methods
- Ozone, UV or Hot Water sanitization
- Automatic operation and sanitization control