Your need: to analyse an injectable preparation in accordance with Ph. Eur. 2.9.19
Ensure the compliance and safety of your injectable preparations with FILAB, experts in particle counting
according to European Pharmacopoeia 2.9.19. Our accredited laboratory carries out precise analyses to detect and quantify visible and sub-visible particles, guaranteeing the quality and integrity of your pharmaceutical products.
What is standard Ph. Eur. 2 9 19?
First of all, the acronym Ph. Eur. stands for European Pharmacopoeia.
Standard Ph. Eur. 2.9.19 concerns the problem of analysing the particulate contamination of injectable preparations.
According to Ph. Eur. 2.9.19, Particulate contamination of injectable preparations and preparations for infusion is the unintentional presence in these preparations of undissolved, mobile substances other than gas bubbles.
This contamination may come from a variety of sources and should be reduced as far as possible. The level of particulate contamination in parenteral preparations must therefore be monitored.
Particle counting methods according to pharmacopoeia 2-9-19
Ph. Eur. 2.9.19 describes two methods for determining particulate contamination:
Method 1: particle counting by light blocking.
Method 2: particle counting by microscopy.
Method 1 should preferably be used for the detection of non-visible particles in injectable and infusion preparations. However, in certain cases, it may be necessary to carry out successive counts by blocking the light and then by microscopy in order to determine whether the preparation complies with the requirements.
The support of a laboratory competent in particle analysis in accordance with Ph. Eur. 2.9.19 is therefore essential when dealing with the problem of particle contamination.
Injectable preparations covered by pharmacopoeia 2.9.19
Find the list of injectable preparations concerned by the analysis of particulate contamination in accordance with Ph. Eur. 2.9.19:
- Injectable solutions (aqueous or non-aqueous).
- Injectable suspensions.
- Injectable emulsions.
- Injectable biological products (vaccines, monoclonal antibodies, therapeutic proteins).
- Cell and gene therapy products.
- Intravenous infusion products.
- Injectable medicines for parenteral administration (intravenous, intramuscular or subcutaneous).
- Injectable ophthalmic products (intraocular injections).
Why analyse particles in injectable preparations?
Particle analysis is essential for the pharmaceutical and biotechnology industries to assess and control particulate contamination in injectable preparations. By following the strict requirements of European Pharmacopoeia 2.9.19, this analysis ensures that injectable products comply with precise limits of visible and sub-visible particles.
These particles, whether of organic, inorganic or biological origin, can provoke immune reactions or inflammatory reactions, endangering patient safety. In compliance with these standards, controls help to preserve the integrity of formulations, particularly for vaccines, monoclonal antibodies, infusion products and other injectable treatments used in oncology, immunotherapy or intensive care.
FILAB provides particle count analysis by microscopy for injectable solutions: vaccines
Why choose FILAB for medical particle counting?
FILAB offers manufacturers specialising in the medical and pharmaceutical sectors the technical skills and cutting-edge analytical equipment they need to meet their requirements as effectively and reactively as possible (it is possible to carry out these analyses urgently) and to provide them with the most appropriate services and tailor-made monitoring.
In order to provide an accurate and reliable response to these problems, FILAB offers tailor-made support for particle counting in accordance with method 2 of Ph. Eur. 2.9.19, as well as other standards…
FILAB is accredited COFRAC ISO 17025
FILAB, COFRAC ISO 17025 accredited, guarantees reliable analyses that comply with the requirements of the European Pharmacopoeia for particle counting of injectable products. This accreditation testifies to our expertise and our commitment to providing accurate results to ensure the safety and compliance of your pharmaceutical formulations.
Pharmaceutical products :
- Identification of foreign bodies and/or contaminants by SEM-EDX and Binocular Micro-Infrared, in accordance with the Ph. Eur. 2.9.52 guidelines
- Particle counting by Optical Microscopy and Image Analyser, in accordance with USP 788/789 and Ph. Eur. 2.9.19 (method 2)
Medical devices:
- Particle counting by Optical Microscope in accordance with current standards: ISO 19227, ISO 10993-19, USP 788, Ph. Eur. 2.9.19, AAMI TIR 42
- Particle identification by SEM-EDX and µ-IRTF in accordance with current standards: ISO 10993-19, Ph. Eur. 2.9.52, PE 2.2. 24, AAMI TIR 42
Our analysis for injectable products
FAQ
Particle counting by microscopy, in accordance with standard European Pharmacopoeia PE 2.9.19, is a method used to detect and quantify visible and sub-visible particles in injectable preparations. It enables particle contamination to be assessed in accordance with the requirements of the European Pharmacopoeia, thereby guaranteeing the quality and safety of injectable pharmaceutical products.
This method offers a high level of precision thanks to visual analysis, and enables you to differentiate between the types of particles present. It is particularly useful for investigating the causes of contamination, validating manufacturing processes and ensuring that batches comply with European Pharmacopoeia standards. Microscopic counting is therefore an essential tool for guaranteeing the quality of injectable products.
