Pure Steam+WFI+WFI distribution Integrated system

KEYPACK distinctive Three-In-One: Pure steam preparation+WFI preparation+WFl distribution integrated system, specifically developed for small capacity multifunctional systems that handle the common pain points of asset-lite requirements, limited space, and insufficient public media for customers such as laboratories, medical devices, and entrepreneurship parks.

This solution is designed in a modular manner according to GAMP, cGMP, ISPE, and FDA guidelines, allowing for free switching between pure steam and injection water production within the total production capacityrange. In hot standby mode, the vapor positive pressure meets GMP requirements and can be started very quickly. At the same time, the compact structure only requires minimal floor space.

  • Pure Steam Generator,WFI Preparation and Distribution

    Electric heating option
  • No waste of machine efficiency

    Free switching between pure steam and WFI capacity within the total capacity range
  • Positive vapour pressure in standby

    The most scientific GMP static protection measures
  • Hot standby, fast startup, stable output during vapor-liquid co-phase

  • Modular functional components

    Effective risk avoidance
  • Lifting membrane design

    Maximize energy-saving benefits
  • Unattended, small footprint, no sterilization blind spots

Technical parameters / Layout / P&ID

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Maximum capacity

At the same time WFI+PS maximum capacity

500L/h+500Kg/h

WFI Max capacity only

1000L/h

PS maximum capacity only

1100Kg/h

Allocate system peak usage

10000L/h



After-sales After-sales support

Project implementation of the full life cycle management, from design selection, program optimization, installation and commissioning, validation support, after-sales maintenance of the whole series of one-stop service.

Regulation & Validation

· CP/USP/EP/JP

· GMP/cGMP

· FDA/CE

· ASME

· GAMP5

· ISPE

Documentation

· DQ/IQ/OQ/PQ

· RA

· VAT

· FAT

· SAT