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Haasrode Manufacturing Facility

An automatic filling line in the cGMP cleanroom at our Haasrode, Belgium manufacturing facility.

  • Main laboratory
  • Headspace-GC-MS Gaschromatograph with Mass-Spectrometer
  • Laminar Flow Unit for molecular biological or microbial tests
  • Flame-AAS (Atomic Absorption Spectrophotometer)

Core Capabilities

  • Filling of pharma-grade solvents and liquids, liquids in general, and solids in pharma and non-pharma grades
  • Mixing capabilities: water-based, solvent-based, corrosive-based, and custom-made solutions

Industry Segments and Applications

  • Pharma and Biopharma

Major Products

  • Water Pharma Ep/USP/JP grade as well as WFI bulk
  • IPASEPT 70 Sterile Spray (70% 2-Propanol)
  • Ethanol EP/USP
  • Sodium Chloride
  • Sodium Hydroxide

Quality Systems

  • ISO9001, ISO14001, OHSAS18001
  • cGMP certificate

Quality Control Capabilities and Instrumentation

  • Analytical instrumentation capabilities: HPLC, ICP, GC, GC-MS, UV-VIS, FT-IR, TOC, Titration, Karl Fisher, pH, Conductivity, and more
  • Analytical testing capabilities: Compendia specification testing (USP, NF, EP, JP, BP), general chemistry testing
  • Functional testing to a variety of custom requirements, utilizing customer instrumentation, where applicable
  • Molecular testing capabilities: PCR, DNase, RNase, Protease
  • Microbiology testing capabilities: bioburden, endotoxin
  • Technology transfer: method and instrument transfer for custom needs
  • Method, equipment, and environment validation
  • ISO 17025 (calibration and test)

Major Production Equipment Details

  • 3 ATEX automatic 2-head filling lines
  • Automatic 4-head filling line (volume upto 250ml/bottle)
  • Semi-auto filling line for liquids
  • Semi-auto filling line for solids
  • Mixing capabilities

Controlled Environment Manufacturing Capabilities

  • Multiple ISO Class 7 cGMP filling rooms for solids
  • Multiple ISO Class 7 cGMP filling rooms for liquids (4 Atex room)
  • Multiple ISO Class 8 filling room for liquids
  • Multiple ISO Class 7 cGMP mixing rooms