Arklow, Ireland Facility Overview

Commercial Scale, Generic API & Advanced Intermediate Manufacturing

Our Arklow (Ireland) site is our primary center for cGMP production of commercial and late-stage APIs and Advanced Intermediates. The 64,000 m2 complex supports customers with expertise in new process evaluation, process development validation and technology transfer. The site is also equipped with one of the few large-scale Simulated Moving Bed (SMB) chromatography units for chiral separation and continuous chromatography purifications.

 

Manufacturing

Our facility features four separate cGMP compliant, FDA and HPRA inspected plants, and has a total reactor capacity of over 100,000 L.

Equipment Overview:

 
QTY Equipment Capacity Temp Range
14
Glass Lined Reactors 250 to 8000 L 0 to +150 °C
5 Stainless Steel reactors 4000 to 8000 L 0 0 to +150 °C
1 Hastelloy Reactors 6000 L 0 to +150 °C
1 Hastelloy Filter dryer 3m2 0 to +80 °C
1 Stainless Steel Filter dryer 0.7m2 Ambient to +80 °C
1 Glass Lined tumble dryer 4000 L Ambient to +80 °C
3 Centrifuges, SS and Hastelloy   Ambient
8 Stainless Steel high vacuum fractional distillation units 200 to 6000 L Ambient to +180 °C
2 Portable Stainless Steel filters 0.4m2 Ambient
2 Vacuum tray drying ovens up to 200 kg Ambient to +80 °C
  Controlled areas for milling, sieving, delumping and packaging    

 

Analytical Services

Fully equipped and experienced analytical support from raw material testing and release to method development and validation, our analytical teams provide a comprehensive range of services for cGMP operations:

  • LCMS
  • HPLC
  • GC
  • FTIR
  • UV
  • DSC
  • IR
  • Particle Size Analysis

Quality Management

Experienced regulatory teams oversee all FDA and Health Products Regulatory Authority (HPRA) related activities and are responsible for quality control, quality assurance and regulatory affairs. The site’s history includes successful Drug Master File submissions in numerous countries.

  • Skilled quality/regulatory group with track record of successful submissions
  • Site capability for all aspects of QC/QA and regulatory affairs
  • FDA and HPRA inspected and approved-work to ICH Q7, FDA 21 CFR Parts 11, 210 & 211 standards
  • Testing to USP, PhEur, BP and customer requirements-pharmacopendial certification
  • DMF/CEP/CTD preparation and maintenance
  • Process validation

Core Competencies

  • Large-scale SMB chromatography capabilities for chiral separation
  • SMB Technology Overview
  • High vacuum fractional distillation
  • Salt formation – crystallization
  • Powder handling – milling and sieving
  • API custom synthesis
  • Advanced Key API Intermediates

EQP Products list

Arklow manufactures high purity advanced intermediates, excipients, solvents and reagents to appropriate levels of cGMP.

  • N- Acetyltryptophan PhEur
  • Acetic Acid PhEur/USP
  • Hexylene Glycol
  • Octanoic Acid
  • D-Galactose NF/PhEur
  • D-Mannose
  • Low Endotoxin Sucrose
  • Dimethylacetamide
  • Synthecol (synthetic cholesterol) PhEur/USP/NF/JP
  • Cystine Di Hydrochloride
  • Sodium Butyrate USP
  • Monoethanolamine
  • Triethanolamine
  • Ethanol USP/PhEur
  • Squalene USP/PhEur
  • Fumaric Acid NF
  • Methylamine/Ethanol solution
  • 1.25M HCl in methanol
  • Ethanol API grade PhEur/USP