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SKE & EAGLE

Pharmaceutical Grade Purified Water: How to Overcome the Challenges of Endotoxins and Microorganisms?

In the pharmaceutical and biotech industries, water is more than just a solvent—it is the most critical raw material. Even trace amounts of microorganisms or pyrogens (endotoxins) can compromise the safety and compliance of an entire production batch.

Common Industry Pain Points

Many pharmaceutical companies face these critical hurdles in production:

  • Fluctuating Conductivity:Single-pass RO systems often struggle to maintain the stable conductivity required by USP/EP standards.
  • Biofilm Growth:Traditional equipment with “dead legs” or poor design creates breeding grounds for bacteria, leading to excessive endotoxin levels.
  • Lack of Monitoring:Systems without smart monitoring fail to provide the necessary data for quality traceability and audits.                                                                             

SKE&Eagle’s 2-stage RO + EDI Solution

To meet the stringent standards of the medical industry, SKE&Eagle provides more than just equipment—we deliver a high-reliability water treatment process.

  1. 2-stageReverse Osmosis (RO) Technology

By utilizing two consecutive stages of membrane filtration, we push desalination to the absolute limit.

  • 1st stageRO: Removes over 98% of dissolved ions and bulk contaminants.
  • 2nd stageRO: Polishes the water to ensure conductivity remains stable at ≤1.3 μS/cm or lower.

  1. Sanitary Design for GMP Compliance

Our systems are constructed from 304 or 316L stainless steel with Orbital Welding. This “dead-leg free” design eliminates potential breeding grounds for microbes, ensuring long-term sterility.

  1. Intelligent PLC Control Systems

Digital management is the hallmark of Industry 4.0. The SKE&Eagle system supports real-time online monitoring, Automatic Cleaning-in-Place (CIP), and data export capabilities to meet strict audit trail requirements.

🌐 Versatile Industrial Applications

Beyond pharmaceuticals, our RO purification systems are performing excellently in:

  • Bio-pharmaRO water serves as the core pretreatment in pharmaceutical water systems for formulation and cleaning of injectables, vaccines, and biologics, ensuring removal of endotoxins and microbes to meet pharmacopeia standards.
  • Food & BeverageRO water is used in the production of bottled water, beverages, and dairy products, providing a pure, low-mineral base water to ensure consistent taste and microbial safety.
  • ChemicalRO water acts as a high-purity solvent and rinse water in fine chemicals, preventing ions and organics from interfering with reactions and improving product purity and process stability.
  • CosmeticsRO water is used in the formulation of premium skincare and personal care products, providing a sterile, impurity-free base solvent to avoid allergens and microbial contamination.
  • ElectronicRO water serves as the foundational water for cleaning and cooling in semiconductors, chips, and photovoltaic materials, and after further polishing reaches ultrapure levels to prevent trace contaminants from causing device failure.

🤝 Partner with SKE&Eagle for Production Safety

Your production process deserves a more stable and purer water source.

Are you struggling to meet water quality standards?

Leave a comment below or send me a direct message to receive the SKE&Eagle Customized Water Treatment Technical White Paper.

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