Pure steam generator for Pharmaceutical and Industry applications Unotherm® HL

The Unotherm® HL is intended for pharmaceutical industry sterilizers with more stringent requirements on the piping classes and welding method and which need to be equipped with a pure steam generator of a correspondingly higher quality design (materials, surface finishes, weld seams, tube bundles, heating elements, etc.).

External machine dimensions in mm (H x W x D)

with base and front panel

1.918 x 1.040 x 970

without base and front panel

1.798 x 1.000 x 950

Technical data subject to change without notice.

For an independent pure steam supply

  • Construction designed in accordance with DIN EN 14222
  • Beside and above versions available
  • Available in two power levels (54 or 81 kW)
  • Compatible to pipe classes for MMM pharmaceutical sterilizers
  • Droplet separator for the reduction of endotoxins
  • Closed feed module with ventilation via sterile filter
  • Simatic control system with 7“ display
  • Software validation in accordance with DIN EN 62304 and GAMP 5 (optional)

Top Features

  • Pure steam generator in horizontal design for pharmaceutical sterilizers
  • GMP compliant system design
  • Reliable Siemens control system compliant with FDA CFR 21 Part 11
  • Feed water module for thermal degassing
  • GMP-conform system design: optimally drainable / product-contacting materials 1.4404 / 1.4434 (AISI 316L) / FDA-conform product-contacting seal materials / product-contacting surfaces Ra < 0.8 µm / product-contacting pressure sensors with hygienic, thermally stable diaphragm seals
  • BESIDE and ABOVE models (limited functionality) available
  • Available in two power ratings (54 or 81 kW)
  • Optimally compatible with the MMM piping classes H14 and H20 of the MMM pharmaceutical industry sterilizers
  • Closed supply module with ventilation via sterile filter and facility for thermal feed water degassing.available as an option, use of hot feed water without downstream cooling possible (e.g. hot WFI)
  • Simatic controller with 7” display
  • Control software conforms to CFR Part 11 (audit trail, user management, …)
  • Communication with other systems (e.g. sterilizers, WFI systems) via Profinet possible
  • Sustainable thanks to effective thermal insulation of the boiler and pipes, option to use hot feed water without downstream cooling as well as option for blow-down water cooling via a heat exchanger with connection to on-site cooling circuit
  • Droplet separator to reduce endotoxins
  • Software validation in acc. with DIN EN 62304 or GAMP 5
  • Comprehensive FAT and qualification documentation (FAT, IQ, OQ, PQ)
  • Extended technical machine documentation (FDS, HDS, SDS, weld seam documentation, etc.)
  • Sampling points for sterilization steam condensate and feed water

Downloads

Download the brochure and find out more about the Unotherm® HL

Contact information

MMM Group
Semmelweisstraße 6
82152 Planegg/Munich
Germany

+49 89 899 18-0 info@mmmgroup.com Contact

Costumer Service

service@mmmgroup.com