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Low temperature generation of HPW and WFI

The pharmaceutical industry fundamentally requires water in two levels of purity for production: Clean water in PW quality (Purified Water) and water for injection (WFI). The high WFI quality can be produced via technical methods using filtration or distillation processes. However, only distilled water is currently approved for injection purposes in Europe. Filtrated water of the same quality is therefore designated as “Highly Purified Water” (HPW).

 

Ultrafiltration

The basic medium for this “cold” treatment technology is clean water in PW quality. The separating procedure with hollow fiber polysulphone membranes achieves a separation limit far below the size of bacteria, viruses and pyrogens. Ultrafiltration therefore delivers ultra pure water which, depending on regional regulations, satisfies the quality criteria for both HPW and WFI.

 

Vacuum membrane distillation

This new and patented technology is a highly efficient and robust process for distillation using a membrane for droplet separation. Thanks to this combination potable water can be directly processed to WFI quality without intermediate steps. The drinking water is first vaporized under vacuum conditions. Then the steam passes through a hydrophobic membrane which separates droplets. Suspended solids, dissolved organic materials, ions, bacteria and endotoxins are segregated during distillation. The process is continuously monitored by online measurements of TOC (Total Organic Carbon), pressure, temperature and conductivity. The multistage process provides a highly efficient heat recuperation while it operates at comparably low temperatures between 50 °C and 80 °C. The entire system can be sanitized periodically by means of heated water.

 

Render VMDU Front_mit Screen

 

 

With these technologies, Bosch provides two reliable procedures for manufacturing pharmaceutical water to WFI or HPW quality, which both display far greater energy efficiency and cost efficiency in comparison to classic high temperature distillation.

 

Contact
Klaus H. Schreiber
Marketing Responsible
phone: +49 (351) 28278-833
email: klaus.schreiber@bosch.com

9 Responses

  1. Joe Manfredi says:

    I don’t see this product listed on the main Bosch website.
    Is this an available product and is there additional technical information available?
    Possibly I’m not looking in the correct sections

    • Dear Mr. Manfredi,
      we will soon publish the vacuum membrane distillation unit on our website. Meanwhile, please be informed that we currently have four types in our portfolio for 1000, 2000, 3000 and 4000 liters/hour WFI generation. The operating temperature range of the system is between 50° and 80 °C.

      Further details like e.g. energy consumption or blow down depend on system size resp. fed water quality and can be submitted in case of a specific requirement submitted by a formal inquiry to packaging.technology@bosch.com

      Kind regards
      Klaus Schreiber

  2. Magdy Gad says:

    May I have more information about that method. What kind of membrane is that, life time.

    • Dear Eng, Magdy Gad,
      membranes are made of certified material with excellent thermal and chemical stability. Characteristics are hydrophobic to allow distillation, droplet separation and passing of pure steam. Lifetime of membranes has proven at least five years in similar applications.

      Kind regards
      Klaus Schreiber

  3. Achille Ghilotti says:

    can I have more info’s on this technology?
    is this approved in EU Pharmacopeia or Just for USP?
    what is the capacity available in Lt/h?

    • Stefanie Krauß Stefanie Krauß says:

      Dear Mr. Ghilotti, thanks for your interest in our technology. One of my colleagues will get in contact with you soon to answer your questions. Kind regards, Stefanie Krauß

  4. It’s a great idea but is it expensive?

    • Rafael Navarro-Droz says:

      Not only a great idea, but quite efficient in functionality and also cost efficient!.

    • Dear Saied Abdalla,
      one main economic advantage of the unit is that it saves specific pre-treatment steps depending on the feed water quality. Compared to a classic setup with purified water generation unit and subsequent high-temperature WFI still the overall investment and operating costs as well as space requirements are significantly lower.

      More data can be submitted to you based on a specific requirement and formal inquiry to packaging.technology@bosch.com
      Kind regards
      Klaus Schreiber

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