One of the performance characteristics of radiello sampling systems, foreseen by the UNI EN 838 (working environment) or UNI EN 13528 (ambient air) standards, is the white level, i.e. the mass of the substance, or substances of interest, detected in the new cartridges. From each batch of product cartridges some cartridges are randomly extracted, on which the white level is determined. The check is carried out immediately after the end of the production process; the lot is released for shipment only if the masses of the compounds of interest detected in the cartridges are all lower than the predetermined acceptability values (“Certificates of Analysis”). These values have been set to at least comply with the requirements of the UNI EN 838 and UNI EN 13528 standards.
The raw materials used in the production of the radiello diffusive samplers are subjected to incoming quality checks, to verify their compliance with pre-established requirements.
The finished products, with the exception of those that require simple assembly and packaging operations, are subjected to different types of quality controls for each production lot, which may include:
the background contamination level (“white”) of the adsorbing cartridges
the quantity of substance contained in the preloaded cartridges or in the calibration solutions, supplied as accessories supplied with the samplers
the regularity of the morphological characteristics and the integrity of the sampler and accessories components
The introduction of raw materials into the production cycle, as well as the loading of finished products into the shipping warehouse are conditioned by the positive outcome of the respective quality controls, according to predefined acceptance criteria.
Diffusive bodies control
Diffusive bodies are essential components of radiello sampling systems, since the sampling flow values depend on the physical-geometrical characteristics (porosity, internal and external diameter, length) of the diffusion membranes (i.e. the white, blue or yellow hollow cylinders, that make up the diffusive bodies together with head and bottom). To ensure the accuracy and reproducibility of the sampling flow rate it is therefore absolutely necessary to ensure that the physical-geometrical characteristics of the diffusion membranes remain unchanged over time and are the same from batch to batch. The quality control process involves two phases: verification of compliance with the product requirements of the checks carried out by the manufacturer on each batch of membranes; further checks carried out at our laboratories on physical and geometrical characteristics with subsequent verification of compliance with the requirements for use. Some pieces are randomly extracted from each batch for quality control; the lot is released for the production of diffusive bodies only if all the physical-geometrical characteristics satisfy the predetermined requirements (“Certificates of Analysis”).
Compliance with the aforementioned requirements guarantees the consistency of the performances indicated in the technical data sheets of the radiello adsorbing cartridges, when the diffusive bodies are used in the correct combination with the chosen adsorbent cartridge.
Traceability of samples
For all radiello samples (including those used for batch quality control), the laboratory continuously stores all the information relating to each analytical parameter, from acceptance to printing and dispatch of Test Reports (or Analysis Certificates), also making use of a LIMS (Laboratory Information Management System). Each radiello sample is uniquely identified and the progress of the analysis process is constantly monitored.
Data security is guaranteed by an advanced protection and archiving system.
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