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