You wish to perform a particle contamination analysis in lyophilisates
What is a lyophilisate?
A lyophilisate is a solid product obtained by the lyophilisation process, also called sublimation drying. This technique involves freezing a product (solution, suspension, extract...) and then removing the water it contains in the form of vapor, without going through the liquid state.
The result is a dry, porous and light substance that retains its chemical, biological or pharmaceutical properties.
Lyophilisates are particularly used to improve the stability, preservation and ease of transport of products sensitive to moisture or heat.
Your challenge: controlling particles in your lyophilised products
In the pharmaceutical and biopharmaceutical industries, the purity of lyophilizates is not only a quality requirement, but also a key regulatory obligation. Beyond chemical contamination, the presence of unwanted particles poses a major risk. These particles, often invisible to the naked eye, can compromise patient safety, product efficacy, and even the stability of your formulation. They can come from a variety of sources: the production environment, raw materials, equipment wear, packaging materials (glass, rubber), or even degradation of the product itself.
Why is particle analysis essential for lyophilisates?
The purity of lyophilizates is essential, and it goes far beyond their chemical composition. The presence of unwanted particles, even microscopic ones, can have serious consequences for the safety, efficacy, and compliance of your products.
Patient and consumer safety : is the top priority. Injecting or ingesting particles can cause serious adverse reactions (embolism, inflammation, irritation, thrombosis), particularly for injectable products. For ophthalmic products, they can cause injury.
Product quality and stability: The presence of particles may indicate a problem in the manufacturing process or formulation instability. They can act as nucleation sites for product degradation or impair its reconstitution.
Strict regulatory compliance: regulatory agencies such as the FDA (USP <788>, <790>), EMA (Ph. Eur. 2.9.19) impose strict limits for visible and sub-visible particles in parenteral and ophthalmic products. Non-compliance can result in batch rejections, costly recalls, and severe penalties.
Process optimization: Identifying the nature and origin of particles helps optimize manufacturing processes, select better packaging materials and minimize future contamination risks.
The FILAB laboratory supports you in the analysis of particulate contamination in lyophilised products
Why choose FILAB for particulate contamination analysis in lyophilisates products?
FILAB is the ideal partner for analyzing particulate contamination in lyophilised products thanks to its recognized expertise and state-of-the-art analytical equipment. We use techniques such as optical microscopy, SEM-EDS, and Raman/FTIR spectroscopy for complete and accurate particle characterization. Our laboratory operates under ISO 17025 accreditation and complies with Good Laboratory Practice (GLP), guaranteeing the reliability and traceability of its results. Beyond analysis, we help you identify the source of contamination and optimize your processes.
OUR other SERVICES
Our resources
Organic chemical analysis
GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, NMR, FTIR
Powder analysis
XRD, SEM-FEG EDX, BET, Laser Granulometry
Mineral chemical analysis
ICP, XRD, IC
Thermal analysis
TGA, TGA-FTIR, DSC
Surface characterization
SEM-FEG EDX, XPS, TOF-SIMS
FAQ
Particulate contamination refers to the presence of any undesirable substances, whether visible or sub-visible, in a freeze-dried product. These particles are not intended to be part of the product. They can be of various types: cellulose fibers, glass fragments, rubber particles from caps, metal residue from equipment wear, crystals, or even aggregates from the product itself (inherent).
We screen for a wide range of particles, categorized into three main categories:
- Extrinsic particles: those originating from outside the product or process, such as textile fibers, glass fragments (vials), rubber particles (caps), plastics, or metal debris (equipment).
- Intrinsic particles: those originating from primary packaging materials and released into the product (e.g., glass fibers or silicone particles from vials/pre-filled syringes).
- Inherent particles: those formed by the product itself (e.g., protein aggregates, precipitates of the active ingredient, or excipient crystals), often related to formulation instability or a suboptimal freeze-drying process.
Quality Risk Management (QRM) is fundamental. It involves identifying and assessing particulate contamination risks at every stage of the manufacturing process, from raw material to packaging. QRM helps determine where controls are most critical, what testing is required, and how often. This risk-based approach allows for efficient resource allocation to proactively ensure product safety and regulatory compliance.
