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.
Particulate counting methods according to Pharmacopoeia PE 2-9-19
The EP 2.9.19 standard describes two methods for determining particulate contamination:
Method 1: particle counting by light obscuration.
Method 2: particle counting by microscopy.
Method 1 is preferably used to detect non-visible particles in injectable preparations and preparations for infusion. However, in some cases, it may be necessary to carry out light obscuration counting followed by microscopy in order to determine whether the preparation meets the requirements.
Thus, the support of a laboratory competent in particle analysis according to the EP 2.9.19 standard is essential when dealing with particulate contamination issues.
To go further, we can carry out particle identification analysis using SEM-EDX and micro-FTIR.
FILAB is COFRAC ISO 17025 accredited
- Foreign body and/or contaminant identification by SEM-EDX and binocular micro-infrared spectroscopy, according to Ph. Eur. 2.9.52 standards
- Particle count testing by optical microscopy and image analysis, according to USP 788/789 and Ph. Eur. 2.9.19 (Method 2)
- Particle counting by optical microscope according to 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 according to current standards: ISO 10993-19, Ph. Eur. 2.9.52, Ph. Eur. 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).
Find the standards FILAB masters for performing particulate counting:
Our analysis for injectable products
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.
