Contaminants and foreign bodies
The discovery of a “foreign body” in a production batch is one of the biggest problems facing manufacturers. Thousands of tonnes of product can be lost when an unknown entity is discovered, and the cost of writing off or recalling a batch can run into millions of pounds.
Concept Life Science can use their expertise and experience, plus unrivaled range of analytical equipment, to help you identify the foreign body and determine its source. Our fast turnaround investigations can solve the immediate problem, and help you prevent expensive and frustrating recurrences.
Utilizing our suite of high-end analytical instrumentation and focussing initially on non-destructive testing we offer a rapid and confidential service.
The initial focus is on optical microscopy and spectroscopic analysis (FT/IR, Raman spectroscopy) with the output spectra compared to extensive spectral libraries for identification purposes. Our suite of Malvern Panalytical Morphologi 4-ID instruments are fundamental to these investigations.
Combining these analyses with a simple elemental analysis technique (e.g. scanning electron microscopy with Energy Dispersive X-Ray Analysis, SEM-EDX), allows for the ready identification of the majority of foreign bodies, e.g. polymers, sealants, gaskets, filter materials, packaging materials, hair, wood, bone, glass etc.
In depth investigation
Should the initial investigation not succeed in identifying the contaminant, then more extensive physical and chemical characterization may be required. Our full suite of analytical equipment is available to support this, including (but not limited to): GC-MS/MS (including NIST libraries), ICP-MS, LC-MS/MS, X-Ray diffraction, automated image analysis and NMR.
Our analyses are supported by extensive in-house and external reference libraries and databases. Note that some of these techniques are destructive.
- Analyses are performed on foreign body itself assessing surface and bulk characteristics; sample handling should be minimized prior to analysis, so as to prevent contamination.
- Information regarding any previous handling or treatment of the sample also aids in the interpretation of the results attained.
- Photographs of the foreign body in situ can assist with interpretation, as can a good understanding of where it was found, the circumstances surrounding discovery, the manufacturing process itself, and the other types of material expected to be present.
- Where a source is suspected, a comparison sample can be supplied and will be analyzed alongside the foreign body; alternatively, literature data can be sourced for comparison purposes.
Bioanalysis and biomarkers
Cleaning validation and verification
Clinical and commercial manufacturing
GXP analytical method development, validation and transfer
Out of specification investigations
Process research and development and pre-clinical API manufacture
QC release and GMP release testing
Storage stability studies