Are you looking to perform candling analysis of your pharmaceutical products?
Candling, or visual inspection, is a very important quality control test in the production of drugs and more particularly for injectable products. Indeed, the purpose of candling is to identify the presence of traces of particles, pollution, or a defect of color of the product, visible at the macroscopic level, i.e. with the naked eye.
Candling is part of the Good Manufacturing Practices (GMP) and is an essential step in the control of the conformity of pharmaceutical products. This candling test is even more important for injectable products.
Today, there are 3 types of candling tests:
- Manual candling: performed with the naked eye by an operator
- Semi-automatic candling: candling performed by a machine and an operator
- Automatic candling: candling performed by a machine
In the pharmaceutical industry, many drugs are subjected to candling tests, such as injectable drugs, tablets or gel forms.
Mirage in pharmaceuticals: FILAB analysis at the service of your processes… Zero defects guaranteed!
FILAB can support you in this process, which involves firstly collecting a representative “defect library” and then characterising it using analytical tools such as :
- SEM-FEG-EDX (Scanning Electron Microscope): observation of the defect on the surface or in cross-section (corrosion phenomenon, part breakage, appearance of surface striations, coating detachment, yellowing of polymer materials, inclusion, etc.). Coupled with an EDX probe, the analysis can also be used to perform a semi-quantitative chemical analysis to highlight the presence of external pollution.
- The MO (Optical Miscroscope): particle counting, image analysis, metallographic or crystallographic study, etc.
These visual inspections will provide a better understanding of the appearance of the defect. These analysis can then be supplemented by more in-depth studies of the raw material to understand how its behaviour changes throughout the transformation process, and to highlight any incompatibilities.
From analysis to expert appraisal, the FILAB laboratory responds quickly to all your requests relating to mirages in pharmaceuticals:
- Mirage analysis of pharmaceutical products-
- Analysis of particles and contaminants in pharmaceutical products-
- Research into elementary impurities in accordance with USP 233-
- Forced degradation studies on pharmaceutical products or packaging-
- Problem solving: odour, neck change
- Contract chemical analysis of raw materials and finished products-
- Expertise in pharmaceutical packaging and packaging materials-
- Process audits
