Water for Injection
Puretech offers world leading solutions for the production of Water for Injection.
Puretech is the market leader in designing and engineering systems to produce Water for Injection (WFI). We have solutions to suit all WFI requirements that meet all worldwide standards whether its obtained via distillation or membrane technology.
FAQs About Water for Injection
- Is it possible to produce hot water from a membrane system?
No, it is not possible to produce hot water from the technology itself, but the water could be heated once it is in the tank, or even before by adding a heat exchanger between the generation system and the storage tank.
- Can an existing purified water (PW) system be converted to a WFI
In theory a purified water system can be converted to a WFI generation system from a water quality perspective but in reality there may be issues when it comes to validating the system and ensuring that the regulators are happy that it is producing WFI and not PW.
- Where would you recommend installing an online microbial monitor?
Puretech would recommend installing an online microbial monitor at the return end of the distribution loop, before the water goes back into the storage tank.
- Are there any situations/processes where you would not recommend the membrane technology?
Not really, EUR Pharmacopeia, US and JP Pharmacopeia all allow membrane technology, but Puretech would recommend checking with your regulator to see whether they would accept membrane technology to obtain WFI, and if they will not it could be considered a risk.
- Does regulatory guidelines allow cold WFI distribution ?
Yes. Water temperature is not one of parameters for WFI but certain applications that WFI is used for will require hot water.
- Is it necessary to sterilise a membrane WFI generation system, from a regulation point of view (given that WFI is it a sterile media)?
Puretech recommends regular heat sanitisations of generation systems to ensure they deliver the quality of water required, especially from a bacteria perspective.
- Is further treatment of WFI required when storing it in a tank?
No further treatment is required for stored WFI, but Puretech recommend that if you are storing it cold to maintain a temp below 20°C.
- Is it mandatory to have a second stage RO membrane to produce WFI or just advisable?
Puretech recommends a twin pass secondary membrane but it is not mandatory to produce WFI.
- What’s the best sanitisation method for WFI in cold distribution ?
There are three options for the sanitisation of WFI in cold distribution – hot water >80℃, super-heated and ozone – all of which are tried, tested and reliable. There are pros and cons for each one so ultimately the decision will depend on how the water is being used in your facility, down time, costs etc.
- Can you advise how to remove the bacterial endotoxin using only membranes?
Puretech would not guarantee meeting the bacterial endotoxin required for WFI without an ultra-filter and regulators would not accept a system without ultra-filtration.
Water for Injection (WFI) is widely used in the pharmaceutical and biotechnology industries, in production but also for washing equipment, vessels etc. WFI is a higher quality than purified water and has it’s own standards set out by the worldwide pharmacopoeias (European Pharmacopoeia, United States Pharmacopoeia, Japanese Pharmacopoeia, etc.).
There are many things to consider when choosing your WFI generation system. Whether the water is to be used hot or cold or a mixture of both? What are the local gas, water and electricity costs? What’s the Capital Expenditure budget?
Puretech has a technology to suit all our clients needs, steam heated Stills or electrically heated Stills, as well as membrane technology systems.
Our Multi-effect Stills comply with all worldwide standards and have been designed where the energy saving distillation has been combined with pure steam generation for increased flexibility and cost reduction.
GENESYS WFI (thermal sanitisation)
GENESYS is the ultimate water purification system – a thermal sanitisation system that provides a single source solution for taking softened water to Water for Injection quality.
OASYS (chemical sanitisation)
OASYS is a chemical sanitisation system that provides a single source solution for taking softened water to Water for Injection quality. Find out more.
AstraZeneca Research and Development Centre
Puretech engineered and installed a purified water to system at the AstraZeneca Research and Development Centre, Cambridge, taking raw water from the mains through purification using OASYS units. The purified water, which is stored in a 5000-litre tank, is distributed via a stainless-steel ring main to user points in the laboratories.