Microbiological Analyses
Keeping products and environments safe from pathogens.
Safety, especially when assessed by a laboratory, depends on the analysis and control of what cannot be seen: microorganisms.
The presence of microorganisms can compromise the validation of a product or production process, as many microbial species exist and several of them pose risks to human health.
This aspect becomes particularly critical when considering medical devices, which, due to their intended use, can pose serious health risks if contaminated.
Techno Analisys specializes in microbiological analyses commissioned by companies, including those related to occupational hygiene, as well as by professionals directly involved in agricultural activities who require information about water or soil quality.
We provide the following microbiological analyses:
- cytotoxicity testing (UNI EN ISO 10993-5);
- cleanroom monitoring: biocontamination (air and surfaces) according to UNI EN 17141, and airborne particle concentration determination according to ISO 14644-1;
- bioburden testing (evaluation of microbial load) and related validation in accordance with UNI EN ISO 11737-1;
- bioburden testing on surgical masks according to UNI EN ISO 11737-1 and BS EN 14683;
- chromogenic LAL test according to the European Pharmacopoeia, USP and ISO 11737-3;
- sterility testing and related validation according to the European Pharmacopoeia and UNI EN ISO 11737-2;
- antibacterial activity evaluation according to ISO 22196 and ISO 20743;
- biological evaluation and classification of medical devices (ISO 10993-1).
Cytotoxicity Test
UNI EN ISO 10993-5
The cytotoxicity test, based on the in vitro biological response of mammalian cells, is essential to assess the overall toxicity of a medical device intended to come into contact with the human body.
Cleanroom Monitoring
UNI EN ISO 14644-1 and UNI EN 17141
A cleanroom is an environment that must comply with strict cleanliness requirements and specific technical characteristics to ensure the safety of production processes.
Techno Analisys performs monitoring of biocontamination in air and on surfaces, as well as the determination of airborne particle concentration.
Bioburden Testing
UNI EN ISO 11737-1
In technical terminology, bioburden refers to the total microbial load present on a medical device.
This microbiological analysis can be performed on virtually any product and has become particularly important in recent years with the widespread use and regulatory requirements for surgical masks.
Chromogenic LAL Test
In accordance with European Pharmacopoeia, USP and ISO 11737-3
This test measures the concentration of bacterial endotoxins, compounds produced by Gram-negative bacteria that may cause severe adverse reactions and are difficult to eliminate.
Sterility Testing
UNI EN ISO 11737-2
This test verifies the complete absence of viable microorganisms on products and devices.
It is required in the biomedical sector when a company manufactures products declared as sterile.
Antibacterial Activity Evaluation
ISO 22196 and ISO 20743
This test is performed on textile materials to evaluate their antibacterial properties.
The purpose of the assessment is to ensure the reduction of bacterial load during product use.