Your need: perform a particulate count analysis on an injectable product according to PE 2.9.19
Ensure the compliance and safety of your injectable preparations with FILAB, an expert in particle counting according to European Pharmacopoeia 2.9.19.
Our FILAB laboratory is accredited and carries out precise analysis to detect and quantify visible and sub-visible particles, ensuring the quality and integrity of your pharmaceutical products.
FILAB provides particulate count analysis by microscopy for injectable solutions: vaccines
Why choose the FILAB laboratory for particle counting in a medical context?
FILAB offers industrial companies specializing in the medical and pharmaceutical sectors technical expertise and state-of-the-art analytical equipment to respond as effectively and responsively as possible (with the option of carrying out these analysis urgently) to their requests and provide them with the most suitable services and tailored support.
To address these issues with precision and reliability, FILAB offers tailored support for particle counting according to Method 2 of EP 2.9.19, as well as other standards...
FILAB, accredited COFRAC ISO 17025, guarantees reliable analysis that comply with the requirements of the European Pharmacopoeia for particle counting.
Méthodes de comptage particulaire selon la pharmacopée PE 2-9-19
Le référentiel PE 2.9.19 décrit deux méthodes pour la détermination de la contamination particulaire :
Méthode 1 : comptage des particules par blocage de la lumière.
Méthode 2 : comptage des particules par microscopie.
La Méthode 1 est à utiliser de préférence pour la recherche des particules non visibles dans les préparations injectables et les préparations pour perfusion. Il peut cependant être nécessaire, dans certains cas, de procéder successivement au comptage par blocage de la lumière puis par microscopie pour pouvoir déterminer si la préparation est conforme aux exigences.
Ainsi, le support d’un laboratoire compétent dans l’analyse de particule selon le référentiel PE 2.9.19 est essentiel dans le cadre de la problématique de la contamination particulaire.
To go further, we can carry out particle identification analysis using SEM-EDX and micro-FTIR.
FILAB est accrédité COFRAC ISO 17025
- L'identification de corps étrangers et/ou contaminants par MEB-EDX et Micro-Infrarouge Binoculaire, suivant les référentiels PE 2.9.52
- Le comptage particulaire par Microscopie Optique et Analyseur d'images, selon l'USP 788/789 et la PE 2.9.19 (méthode 2)
- Le Comptage particulaire par Microscope Optique selon les référentiels en vigueur : ISO 19227, ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
- L’Identification particulaire par MEB-EDX et µ-IRTF selon les référentiels en vigueur : ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42
Injectable preparations covered by pharmacopoeia PE 2.9.19
Find the list of injectable preparations subject to particulate contamination analysis according to the reference PE 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).
Retrouvez les référentiels que FILAB maîtrise pour la réalisation de comptage particulaire :
Nos analyses pour produits injectables
FAQ
Particle counting by microscopy, according to the EP 2.9.19 standard, is a method used to detect and quantify visible and sub-visible particles in injectable preparations. It makes it possible to assess particulate contamination in accordance with the requirements of the European Pharmacopoeia, thereby ensuring the quality and safety of injectable pharmaceutical products.
This method offers high precision thanks to visual analysis and makes it possible to differentiate between the types of particles present. It is particularly useful for investigating the causes of contamination, validating manufacturing processes, and ensuring batch compliance with European Pharmacopoeia standards. Microscopy-based counting is therefore an essential tool for ensuring the quality of injectable products.
First of all, the acronym EP stands for the European Pharmacopoeia.
The EP 2.9.19 standard addresses the issue of particulate contamination analysis in injectable preparations.
According to EP 2.9.19, particulate contamination in injectable preparations and preparations for infusion is the unintentional presence, in these preparations, of undissolved, mobile substances other than gas bubbles.
This contamination can come from various sources and must be reduced as much as possible. Thus, the level of particulate contamination in parenteral preparations must be controlled.
Particle analysis is essential for the pharmaceutical and biotechnology industries in order to assess and control particulate contamination in injectable preparations. By following the strict requirements of the European Pharmacopoeia 2.9.19 standard, this analysis ensures that injectable products meet precise limits for visible and sub-visible particles.
These particles, of organic, inorganic or biological origin, can trigger immune reactions or inflammatory responses that put patient safety at risk. In compliance with this standard, controls help preserve the integrity of formulations, particularly for vaccines, monoclonal antibodies, infusion products, and other injectable treatments used in oncology, immunotherapy or intensive care.
