SAFC Arklow Facility Focus

Commercial Scale API Manufacturing

SAFC-Arklow, Ireland is the company’s 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.

The site’s history includes successful Drug Master File submissions in numerous countries

Manufacturing

Fully validated cGMP site for commercial-scale API manufacturing, SAFC’s Arklow facility features four separate plants, and has a total reactor capacity of over 90,000 L.

  • cGMP, FDA and IMB inspected
  • 14 glass-lined reactors (250-8,000 L)
  • 5 stainless steel reactors (4,000-8,000 L)
  • 1 Hastelloy® steel reactor (6,000 L)
  • 3 centrifuges (1 stainless steel, 2 Hastelloy®)
  • 8 stainless steel high vacuum distillation units (200-6,000 L), stainless steel filter dryer
  • Hastelloy® filter dryer, stainless steel fluidized bed dryer, glass tumbler dryer (4,000 L)
  • Vacuum tray drying oven (200 kg)
  • Controlled environment sieving, delumping and packaging

Core Chemistries

  • Alkylation
  • Esterification
  • Ester Condensation
  • Reduction
  • Suzuki Coupling

Core Technologies

  • Large-scale SMB chromatography capabilities
  • High vacuum fractional distillation
  • Salt formation - crystallization
  • Powder handling - milling and sieving
  • Grignard chemistry

SMB Chromatography

Quick, cost efficient continuous purification and separation of intermediates and APIs, SAFC-Arklow is one of a few sites in the world able to provide large-scale SMB purification:

  • Licosept 6-450 SMB unit
  • Purity specification to customer demand (up to 99.9%)
  • Scalable – from grams to tons

Analytical Services

With well-equipped and experienced analytical support from raw material QC and release to method development and validation. SAFC’s analytical teams provide a comprehensive range of services for cGMP operations.

The latest in analytical testing, including:

 

– LCMS
– GC
– NMR
– DSC
– Particle Size Analysis
– Microbiological		 – HPLC
– FTIR
– UV
– IR
– Wet Chemistry

 

Quality Management

Experienced regulatory teams oversee all FDA and Irish Medicine Board (IMB) 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 IMB inspected and approved-work to ICH Q7, FDA 21 CFR Parts 11, 210 & 211 standards
  • Testing to USP, EP, BP and customer requirements-pharmacopoeial certification
  • DMF/CEP/CTD preparation and maintenance
  • Process validation
  • Six Sigma quality system philosophy

Product List

SAFC Arklow has the expertise to manufacture custom and generic APIs, to the highest level of quality:

  • Acepromazine Maleate USP/BP Vet
  • Amitriptyline Hydrochloride USP/BP/EP
  • Benzyl Alcohol NF/EP
  • Brompheniramine Maleate USP/BP/EP
  • Butoconazole Nitrate USP
  • 4-Chloro-N-methyl-piperidine
  • Clomipramine Hydrochloride USP/BP/EP
  • Diethylcarbamazine Citrate USP/BP/EP
  • Doxylamine Succinate USP/BP/EP
  • Fumaric Acid NF
  • Lofepramine Hydrochloride BP/EP
  • Nortriptyline Hydrochloride USP/BP/EP
  • Promethazine Hydrochloride USP/BP/EP
  • Sodium Benzoate EP
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