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Analysis of particulate pollution in injectables
Medical industry, you wish to carry out an analysis of particulate pollution in injectables
What is an injectable?
First of all, an injectable product is a drug (gel or solution) injected into the body by parenteral route: intravenous, intramuscular, intradermal or subcutaneous injections.
This type of administration allows an exact dosage of a product, without having undergone any digestive modification. The action of an injected drug is also faster than by oral route.
Injectable drugs are administered with specific equipment such as syringes.
Why carry out an analysis of particulate pollution in injectables?
Injectable products are subject to special attention in terms of production quality. The objective is to guarantee safety throughout the manufacturing process by verifying the absence of particulate pollution in the injectable products. Particulate pollution can be associated with abnormal endogenous particles such as glass particles.
The presence of particulate contamination is a problem that can lead to the withdrawal of the injectable solution or the non-authorization of the marketing.
Therefore, the support of a laboratory competent in the analysis of particulate pollution in injectables is indispensable in the framework of a quality control or an injectable development process.
FILAB assists you in your needs for the analysis of particulate pollution in injectables
Through our three levels of services: analysis, expertise and R&D support, FILAB assists companies in the medical industry with their needs for analysis of particulate pollution in injectables. FILAB provides its customers with the know-how and experience of its team, as well as a 2100m² analytical park equipped with state-of-the-art equipment.
Separative analytical techniques such as GC-MS or LC-MS: identify and quantify organic particles at trace level
Optical Microscopy coupled to Infrared (µ-FTIR): identify inorganic or metallic particles
Scanning Electron Microscopy coupled to an EDX probe (SEM-EDX): identify inorganic or metallic particles
ICP technique (ICP/AES and ICP/MS): identify and quantify trace amounts of inorganic particles from any type of vaccine or injectable
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²