Buchs, Switzerland, Facility Overview

GMP Starting Materials, Key Intermediates and Building Blocks

Our facility in Buchs, Switzerland specializes in the development and manufacturing of complex small molecules. These include critical raw materials, reagents, advanced intermediates to support API manufacturing and excipients from pre-clinical to commercial scale. This FDA inspected and ISO certified site provides a wide range of scale and cGMP manufacturing capabilities. Working in close alignment with our other global facilities, the site in Buchs offers its customers the quality, dependability, and flexibility to move their products to market quickly and efficiently.

 

Manufacturing

Buchs offers a broad range of manufacturing Areas including cGMP kilolabs, batch range size and pilot plant facilities.

Equipment overview:

 
QTY Equipment Capacity Temp Range
3
Laminar flow cabins    
7 Glass lined reactors 1,000-1,600 L -20º to +180º C
5 Glass lined reactors 400-630 L -50º to +180º C
21 Glass lined reactors 63-250 L -40º to +180º C
5 Centrifuges 100 KG  
2 Agitated filter dryers 50 KG  
6 Vacuum shelf dryers 50 KG  
2 Spherical/Tumble dryer 200 KG  
3 Fractional distillation stills 250 L  
1 Thin film evaporator 50 L / day  
8 Rotavaps 20-50 L  
2 Kilo Labs: ISO 8 Clean rooms g to kg scale  

 

Process and Analytical Development Services

  • Scaling and optimizing processes for lab & plant-scale
  • Process validation support (QbD with DOE)
  • Hazard evaluation lab: calorimeter, gasflow, DSC, ARC, Fall hammer, etc.
  • Impurity identification and characterization
  • Method validation and stability testing
  • Analytical instrumentation:
    • Physical data: mp, bp, n, d, viscosity, opt. rotation, etc.
    • Titration: variety of titration methods, KF
    • Spectroscopy: IR, NIR, UV, NMR (H,C,P,F)
    • Chromatography: GC, GC-MS, GC-HS, HPLC, UPLC, HPLC-MS, MALDI-TOF, GPC, TLC
    • Elemental analysis: C, H, N, S
    • Trace analysis: AAS, ICP-OES, ICP-MS, IC
    • Biochemical analysis: CE, gel electrophoresis, fluorescence, enzymatic tests, bio-tests in vitro AAA, enzymatic traces for molecular biology, peptide analysis, endotoxin testing
    • Stability Studies per ICH
  • Bioburden (TYMC, TAMC), external

Quality and Regulatory Services

  • Proven track record of successful DMF submissions
    • Preparation of regulatory filings (NDAs)
  • Customer audits
  • Regular inspections and audits by authorities and customers
    • Control documentation and testing
    • ISO 9001: 2008 management system
    • ISO 13485 (Medical devices)
    • ICH Q7 compliance (APIs)
    • IPEC PQG compliance (Excipients)
    • OHSAS 18001 certification
  • GMP compliant
  • FDA, PMDA, and South Korea MFDS inspected

Project Management

From evaluation to execution, SAFC‘s dedicated project managers are coordinating multi- disciplinary teams, international site activities and timelines throughout the lifecyle of your program. They consolidate and facilitate direct communication by technical leads: