Contadores de partículas en líquidos for the laboratory
Instruments that count and size the particulate matter present in a liquid, normally by light obscuration, for the quality control of parenteral and injectable products and the verification of fluid cleanliness.
contadores de partículas en líquidos guide
Control of particulate matter in injectables and parenterals in accordance with pharmacopeia requirements, verification of the cleanliness of water and process fluids in the pharmaceutical industry, and quality assurance in the manufacture of intravenously administered medicines.
How to choose contadores de partículas en líquidos
- It depends on the applicable standard and the size limits required
- The type of sampling (manual, with an autosampler or in line)
- The size range and the sample volume per analysis
- And the qualification and data traceability requirements. Specific values come from the catalog (Sanity)
Frequently asked questions about contadores de partículas en líquidos
What does the pharmacopeia require for particles in injectables?
USP <788> (and the harmonized EP/JP chapters) sets limits for subvisible particles of ≥10 and ≥25 µm per container or per milliliter depending on the volume. The primary method is light obscuration with qualified equipment.
What is the difference from an airborne particle counter?
They measure different matrices: this one analyzes precise volumes of liquid (parenteral product, water, process fluids) with light obscuration sensors; the airborne one draws in and classifies aerosols. They are not interchangeable.
How is the system validated for a GMP environment?
Calibration with certified size standards, verification of sample volume and counting accuracy, plus documented IQ/OQ and recording compliant with 21 CFR Part 11. Inolab supports qualification and service in Mexico.
Is it suitable for proteins and biologicals that form aggregates?
Yes, subvisible counting is critical in biopharmaceuticals, although translucent aggregates may require complementary methods. It is advisable to evaluate the application with real samples when selecting the equipment.
Brands we represent in contadores de partículas en líquidos
Available contadores de partículas en líquidos models
More caracterización de partículas equipment
- Análisis de partículas
- Contadores de partículas en aire
- Contadores de partículas en aceites y líquidos
- Contadores de células
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