Glantreo Ireland

By: Glantreo  05/12/2011
Keywords: Medical Device, Api, Contamination

Glantreo is committed to providing a quality materials science analysis service to our customers.  We have a ISO standard Quality Managment System in place and we are regularly audited by our customers.  

Glantreo perform a wide range of Materials Science services. Comon tests that we perform are. 

Microscopy

  • Transmission Electron Microscopy
  • Scanning Electron Microscopy
  • Atomic Force Microscopy

Particle Characterisation

  • Powder x-ray Diffraction
  • X-ray Fluorescence
  • Surface Area
  • Pore Size Determination
  • Solid State NMR
  • Particle Size Distribution 
  • IR Spectroscopy
  • Differential Scanning Calorimetry
  • UV-Vis Spectroscopy



SEM of Gold Coated API

Recent projects undertaken by Glantreo:

  1. Identification of rogue particles or foreign bodies in API manufacture
  2. Identification of contaminants on biomedical devices
  3. Identification of unknown materials found in foodstuffs
  4. Process Improvement for API manufacture
  5. Process Development for medical device industry
  6. Physichemical Characterization of Hydroxyapatite (HA)
  7. Corrosion Studies on Stainless Steel Parts
  8. Determination of Asbestos in Drinking Water via Anderson and Long Method 
  9. Identification of Insoluble Matter in API manufacture 
  10. Trace Chemical Unknowns Detection within the Pharmaceutical Industry
  11. Identification of Contamination in Foodstuffs
  12. Morphological inspection of API powders
  13. Non Routine Testing of Chemical Samples
  14. Chemical Composition Analysis of Inorganic Oxides
  15. Particle size analysis of Inorganic Oxides (via Elzone and Malvern systems)
  16. Surface Area Analysis of Inorganic and Organic Materials   
  17. Particle Size Analysis on Dust Samples (Occupational Monitoring)
  18. Emmision Monitoring (Sulphates/Chlorides)
  19. Stack Monitoring
  20. Carbon Black Comparision Testing  

We are willing to consider any Materials Science related problem, and have had significant successes in this area. Here are two particularly significant case studies, in which the expertise of Glantreo was critical to the speedy resolution of Materials Science problems:

Case Study 1 - Novartis Solvent Recovery

An unknown material was found in the Solvent Recovery Plant. It was suspected that the material was a by-product of caustic neutralisation, with the result that the solvent recovery plant had to be closed until the unknown chemical was identified and source of contamination was found. Consequently production in the main plant was stalled until some means to deal with solvent was found. Once Glantreo was called, the result was that the material was quickly identified and as a result the source of contamination isolated. Within 24 hours the main plant was again operational. After a number of consultations between Glantreo and the Novartis Staff the source of the contamination eliminated and the solvent recovery plant brought back up to speed.

Case Study 2 - Janssen Reactor Design

A new API product was recently transferred to the Janseen Pharmaceutical plant in Little Island from its sister site in Belgium. However it was noticed that extensive pitting corrosion on the inside of the existing SS316 reactor was taking place. Glantreo were brought in to test the corrosive nature of the solvent system on SS316 and then to identify which materials show greatest resistance to the solvent system. Due to the extensive workload involved in this project (from both parties) this analysis work was conducted over a 2 week period. After an initial meeting on the Janssen site a project plan was drawn up with clear milestones and deliverables. A final report and presentation of the data was given to Janssen at the end of the project, outlining the main conclusion of the work and recommendations for reactor design.

Keywords: Api, Contamination, Medical Device