BioPharmaceutical Water Purification

Overview

THE DEEPEST EXPERIENCE AND THE BROADEST RANGE OF SOLUTIONS

With thousands of water purification machines successfully installed worldwide, MECO serves leading pharmaceutical and biotechnology companies with over 25 million gallons of product water each day. The MECO global portfolio includes the broadest range of engineered products for Pure Steam, Purified Water (PW), and Water for Injection (WFI). This depth of global experience ensures we understand the critical nature of maximized up-time for your operations. This is why all of our processes are built around you.

Why Do You Need Biopharmaceutical Water Treatment Systems?

For obvious reasons, the biopharmaceutical industry is one of the most closely regulated, and each component of a pharmaceutical production process must be carefully purified and monitored to prevent the contamination of products. From research and development to the manufacturing of biopharmaceutical products, biopharmaceutical water purification plays a fundamental role in every stage of biopharmaceutical operations. The different processes in the pharmaceutical industry require different types of water quality, each with its own testing requirements.

Purified Water

Purified Water (PW) is sufficient for use as a diluent in the production of non-sterile products and for cleaning equipment. Pharmaceutical companies also use purified water as pretreatment in the preparation of Water for Injection (WFI) and pharmaceutical-grade pure steam production.

Some common uses for purified water include:

  • Making pill-form drugs: Purified water is used in the preparation of pill-form medications that are administered orally and absorbed in the human system.
  • Making drugs noninjectable drugs: Other non-parenteral drugs that use purified water during preparation include topical ointments, patches, suppositories and products administered through the ear, eye and nose.
  • Cleaning laboratory equipment: Purified water is the best solution for washing process equipment for non-parenteral product preparation and other product-contact containers. Purified water may also be used in the initial washing of components used in parenteral product manufacturing.
  • Pretreatment for water use: Biopharmaceutical companies also use purified water as pretreatment in systems in the preparation of WFI and pure steam production.

Water for Injection

Water for Injection is the more rigorously regulated pharmaceutical water type in the industry. Water for Injection is used for diluting substances in the manufacturing of parenteral and ophthalmic products, as well as the final rinsing of packaging. According to certain pharmacopeias, you can produce WFI by multiple effect distillation, vapor compression distillation and membrane-based systems.

Biopharmaceutical manufacturers commonly use WFI in the following applications:

  • Making parenteral drugs: WFI meets the stringent purification standards for drugs injected directly into the human system. This class of drugs includes medication injected into the system through the veins, layers of the skin, muscles, heart and spinal canal.
  • Diluting medicinal products: The purification level of this kind of pharmaceutical water makes it a sterile diluent for parenteral drugs.
  • Cleaning laboratory equipment: Biopharmaceutical water purification is necessary for maintaining sterile equipment and preserving the quality of products. Manufacturers use WFI to clean process equipment and containers used in parenteral drug preparation.
  • Filtering the blood in hemofiltration: WFI is also used in the removal of waste products in the blood and the injection of sterile replacement fluids.
  • Producing implantable medical devices: Biomedical manufacturers use WFI to produce implantable medical devices and ensure sterility.

Pure Steam

Pharmaceutical-grade pure steam is also referred to as Clean Steam. Both are direct-impact steams produced by a specialized steam generator. When it condenses, it meets the quality characteristics and monographs specified by Pharmacopoeias and regulators for Water for Injection. Pure steam can often be used for the sterilization of pharmaceutical equipment and product sterilization.

Common uses for pure steam in biopharmaceutical applications include:

  • Sterilizing systems: Biopharmaceutical manufacturers use pure steam to sterilize hard-to-reach equipment such as tanks, piping and filters before and after product manufacturing.
  • Moistening air: Pharmaceutical cleanrooms require sterile humidification. Incorrect humidity control can disrupt the manufacturing processes and lead to irreparable contamination. Air moistening can be precisely controlled using pure steam, which is absorbed into the air without drastically disturbing the air’s temperature.
  • Sterilizing products used in sterilization: Sterilizing pharmaceutical products within the sterilization chamber prevents cross-contamination during the pharmaceutical production process.
  • Sterilizing packaging: A pharmaceutical product’s primary packaging must be sterile to maintain the product’s quality after manufacturing.

Why Choose MECO for Biopharmaceutical Water Purification Systems?

MECO’s Biopharm portfolio includes the broadest range of engineered products for pharmaceutical manufacturing, including PW Systems, WFI and Pure Steam. This depth of technology and experience ensures that we understand the critical nature of maximized up-time for your operations.

Whatever your pharmaceutical water generation requirements may be, MECO answers with the ideal combination of highly experienced engineers, state-of-the-art manufacturing and first-class service. Discover our broad range of products including Multimedia Filtration, Water Softening, Carbon Filtration, Ultrafiltration, Reverse Osmosis, Multiple Effect Distillation, Vapor Compression Distillation, Membrane-based WFI, and Storage and Distribution. Get in touch today to see how we can help you.

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