Particulate contamination of solutions
One of the fundamental principles guiding the pharmaceutical quality of parenteral products is to prevent the injection of particles. The problem of particles is mainly related to the preparation and administration of injectable drugs rather than the contamination of marketed products.
There are several types of injectable particulate matter depending on its sources:
- Glass container
The interactions between the glass and the ingredients of the formulation are possible with the release of glass particles. Among the glass containers, glass ampoules are a source of high-risk particulate contamination because particles can be introduced into the solution when it is opened by the operator.
- Plastic container
Plastic contamination often occurs because of particles which are in the plastic infusion container or the use of sharp objects through the injection septum. Handling and storage ca also influence the initial amount of particles in plastic containers.
- Medical infusion devices
Medical devices for infusion devices (e.g., tubings or catheters) may also release particles from the devices themselves during infusion.
- Undissolved solid particles
Undissolved solids in drug solutions (e.g., category, therapeutic protein products) may also contain particles inherent to the product that are often more difficult to detect and count.
- Drug incompatibilities
Another common cause of particles is the incompatibility of drugs. The drug incompatibilities are chemical and physical reactions between the drugs and / or the carrier fluid when administered intravenously by the same venous access. These incompatibilities can lead to the formation of precipitates.
The presence of particles in solutions infusion requires knowing the elements determining particulate risk for patient. These different elements are: patient characteristics, route of administration, number, size, shape, electric charge and characteristic of particles.
Physico-chemical drug incompatibilities can lead to the IV administration of particles to patients, with potentially serious clinical consequences. The clinical effects are classified in two categories:
- Peripheral clinical effects (phlebitis): studies on this subject are discordant or methodologically weak.
- Systemic clinical effects: the administration of drug particles constitutes a non-negligible risk for patients: inflammatory response with the formation of granuloma, thrombosis, impaire microcirculation or modulated immune response.
In conclusion, the particles in the solutions remain a real problem for the care of the patients.