Failure Analysis - Pharmaceutical Industry
Ceram works closely with manufacturers to identify and solve failures with both pharmaceuticals and packaging both during manufacture and while the product is in use (contamination, delamination, disbondments, leaching, printing failures).
Using physical and chemical testing and a range of surface analysis techniques we can identify the reasons for failure and advise on how best to overcome them.
Our services include:
- Contamination analysis - contamination of pharmaceutical products or drug delivery devices can lead to fatal consequences whilst staining can be dangerous and aesthetically displeasing. At Ceram we use a combination of techniques to:
- Determine the chemical composition of a contaminant or stain
- Fingerprint suspect materials
- Validate the manufacturing process to discover where the contamination was introduced.
- Packaging failures - packaging of pharmaceutical products is vital to ensure that they are fit for purpose when they reach their final destination. Our experts can help you to identify and solve:
- Packaging failures including delamination and disbondments
- Migration and leaching of species from packaging into the pharmaceutical
- Stains and contamination
- Printability issues such as non-sticking of ink.
Ceram has developed a technique called Low Volume Gas Analysis (LVGA). Used to identify gases, vapours or residues in packaging, LVGA can help pharmaceutical manufacturers to ensure that their gas flush systems are functioning correctly and that contaminants that cause process problems or product failures are eliminated.
Examples of projects we’ve worked on:
- ToFSIMS analysis of brown/yellow staining on pharmaceutical ovule blister packaging material
- Investigation into spot defects in metallised pharmaceutical packaging film using Dynamic Secondary Ion Mass Spectrometry (DSIMS)
- An XPS investigation of heat seal strength reduction on drug foil packaging
- Investigation into the variable adhesion of X film bonding to glass beads using X-ray Photoelectron Spectroscopy (XPS)
- ToF-SIMS investigation into the loss of potency of drug X tablets for veterinary medicine
- Investigation into the appearance of brown spots on antibiotic tablets using ToF-SIMS and XPS
- ToF-SIMS investigation into the cause of the yellow discolouration of a drug tablet.
