Bosch launches new WFI system at interpack
Efficient alternative to distillation.
At interpack 2017, Bosch will present its new system for the production of water for injection (WFI). As the name implies, first and foremost WFI is used in solutions for injection and infusion, making it a key component in pharmaceutical manufacturing. To date, it was only possible to produce WFI for the European market using distillation. However, as of 1 April 2017, the revised European Medicine Agency (EMA) Pharmacopeia allows, for the first time, WFI to be obtained using other comparable processes. “Our generation unit is specially designed to meet the EMA requirements,” explains Dr John Medina, Sales Manager at the Bosch subsidiary Pharmatec, which developed the unit.
WFI production using membrane processes
The generation unit employs the 'cold' membrane processing methods reverse osmosis and electrodeionization, together with an additional ultrafiltration step. Reverse osmosis is a physical filtration process that removes ions from the water, and the subsequent electrodeionization further reduces the remaining salt content through a combination of ion exchange and electrodialysis. The unit’s ultrafiltration module then separates out particles such as microbes and pyrogens on the basis of their weight and molecular size. Until now, in the European Union this method was only approved for the production of highly purified water (HPW), whereas in the US and Japan it has already been approved for obtaining WFI. In the future, the process will also be permitted by European authorities – albeit with additional, specific requirements.
Offering both thermal and chemical sanitization
Essentially, the unit must produce water under conditions that prevent the growth of micro-organisms and other impurities. For reverse osmosis systems, the EMA stipulates regular sanitization of the unit using hot water – primarily to prevent the formation of biofilms. Biofilms are caused by microbes, such as bacteria, and are difficult to remove from industrial systems. For additional protection, chemical sanitization must also be an option.
According to Medina: “The unit on display at interpack allows routine thermal sanitization. When it comes to hot water sanitization, temperatures of 85 degrees Celsius can be reached.” In addition, the EMA recommends chemical sanitization using ozone, to minimize the risk of microbial contamination. The unit offers this option as well. To prevent contamination as a result of insufficient barrier properties, the membranes’ integrity is checked on a regular basis.
Bosch has now reworked the WFI unit, including a more hygienic design and built-in measuring technology to monitor the system. The stainless steel used in the storage and distribution systems does not affect the water quality. Further, the system allows all the components to be thermally sanitized at any time.
Process monitoring is essential for water quality
“Monitoring all the processes in the production chain is essential to guaranteeing the microbial quality of the water,” says Medina, “which is why we fitted the unit with various sensors and measuring devices to monitor the water quality throughout the process and to check the individual steps.” Total organic carbon (TOC) is a key indicator of the water’s quality, and since it is also a parameter for the risk of microbial contamination in the overall system, it has to be continually monitored. Conductivity is another important parameter, and here the EMA stipulates inline process control. The unit is equipped with an online measuring system to monitor specific conductivity. To routinely test the water in real time, Bosch has also installed an online microbe counter, which continuously records and quantifies the level of microbes and inert particles using light-induced fluorescence measurements and algorithms. All parameters are centrally monitored and controlled by means of an intuitive interface.
Related News
-
News Women in Pharma: Moving beyond discussions and into best practice at CPHI Milan
In this second CPHI Milan special of our monthly series, we cover the key takeaways from the Diversity & Wellbeing track held on October 10, 2024. -
News CPHI Milan post-show panel: Importance of advocacy projects in business
In the Packaging Innovation Theatre from CPHI Milan this year, sponsored by the Alliance of the RTU, we held a panel on: ‘Elevating Brand Perception: Integrating Advocacy Projects into Business Strategies’. The session aimed to explore how ... -
News CPHI Pharma Awards 2024: Meet the winners from the CPHI Celebration
This year we had a lot to celebrate, the 35th Anniversary of CPHI, and our esteemed award winners, of which we included two additional categories this year, the Future Leader award, and Woman of the Year award. -
News CPHI Milan 2024 - From the Floor
Milan and CPHI welcome you to 2024 CPHI Milan! As we celebrate the 35th edition of our flagship CPHI show, editors Vivian Xie and Lucy Chard bring you the latest from the show floor, conference sessions, and innovative solutions from all exhibitors, at... -
News A Day in the Life of a Pharma Event Director
The Day in the Life of series has covered most of the pharmaceutical supply chain looking through the eyes of the people working in the different fields, from R&D to manufacturing. What we haven't seen yet, is the role that non-pharma companies can... -
News On Track at CPHI Milan: The RTU Alliance on the importance of packaging innovation
As CPHI Milan gets ever closer, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma, and the innovations that are set to shake up the industry. -
News CPHI Milan Speaker Spotlight: The microbiome and investing in future therapies
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conference. -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance