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Pharmaceutical Industry - Cosmetics Industry - Food Industry
Automotive industry - Aerospace industry - chemical industry - Hospital
CONTROLLED EQUIPMENT AND ENVIRONMENTS
Control / Qualification
Barometer and climatic measures:
Check the capacity of the installation, to maintain the differential pressure of the air between the room and its environment.
LClimatic and barometric measurements are carried out using a TSI multifunction device and suitable probes.
Repositories: ISO 14644-3; GMP in strictness, NF S 90-351
AERAULIC MEASUREMENTS (FLOW, UNIFORMITY, LAMINARITY, THR)
Measurement of the average speed of a HEPA filter and calculation of the flow of blow or extraction.
The flow measurements are directly carried out using a barometer thanks to its interchangeable heads. A barometer allows reliable, fast and accurate measurements.
Repositories: ISO 14644-3; GMP, NF 90-351 NF 12469
TEST OF INTEGRITY AND SEALING OF AIR FILTRATION SYSTEMS:
Measurements carried out using a generator capable of producing a test aerosol in a future lover and coupled to a photometer to detect any leaks.
Aerosol + DI-Etyhl-Hexyl-Sebacate Generator DEHS.
Repositories :: ISO 14644-3, GMP in rigor, NFEN 1822
Aerobiocontamination and surface control
Removal of air and surface on the culture medium to determine the state of cleanliness of equipment.
Bio-collector + Impactor
Repositories : ISO 14698-1 GMP in rigor, NFS90-351
Measurements of the dust level of a room or equipment.
TSI particle counter
Repositories: ISO 14644-1, GMP in rigor, NFS 9035)
Mapping and homogeneity of temperature-controlled enclosures
Measures of the homogeneity over time of temperature chambers (incubators / incubators / refrigerators / cold room / water bath etc ...)
Measurements of a number of points representing the volume of the speaker and continuous recording of the data.
Repositories: GMP, NFRX15-140, NF EN 554
QUALIFICATION OF WATER TREATMENT AND DISTRUBUTION INSTRUMENTATIONS
control of the production and distribution systems of purified water.
- Measures of microbial contamination.
- Limit test of nitrates and heavy metals.
- Oxidizable substances.
- Bacterial and fungal identification.
- Measurement of conductivity.
- Determination of bacterial endotoxins.
The samples are taken by the company and sent to the laboratory by refrigerated transport.
CONTROL OF COMPRESSED AIR
Microbiological contaminant control: The HP agar impactor controls the microbiological quality of compressed gases. It carries out the collection of bacteria by impaction on a standard petri dish.
Solid particle control
The use of a particle counter coupled to a suitable expander makes it possible to characterize the particles present in the compressed air, the measured particle sizes are 0.5 μm and 5 μm and the sample must be ISO-kinetic.
Control of the oil or water content
The HP measurement device is used to set the pressure and the inflow inside the reagent tubes, thus measuring several parameters including oil and water content.
sectors of intervention
- Pharmaceutical industry.
- Food industry.
- Health establishment: hospitals, clinics, etc ...
- Cosmetic industries.
- Medical provisions
- Testing and control laboratories
- Fine chemistry.
- Research centers.
Advanced industries (microelectronics, automotive, Aerospace, etc ...)
TSI multi-function device
DRAGER smoke tube
Diluter + impactor
CONTROL OF LIQUID NITROGEN Some pharmaceuticals are sometimes sensitive to moisture and oxygen in the atmosphere. Therefore, they must be protected with an inert gas that prevents degradation and preserves the effectiveness of the drug. Thus, a number of therapeutic proteins are packaged under nitrogen during filling and finishing operations in order to extend their validity. Since liquid nitrogen is in direct contact with the finished drug, we know how important it is to have a gas supply that meets your standards, is reliable and of high quality. Sectors of intervention: In the health care field, liquid medical nitrogen is commonly used in the following applications: Cryopreservation (biobanks) for the long-term preservation of cell lines, tissue samples, stem cells, blood, blood components, other cells and body fluids. As a component or excipient in many gaseous mixtures.
As standard gas for calibrating medical devices. As a sterile equipment transfer means, non-oxidizing atmosphere transfer means in pharmaceutical vials. As a source of pneumatic pressure for medical devices operating with gas. As a refrigerant for surgical lasers with carbon dioxide. Cryo-grinding uses liquid nitrogen to cool very precisely (up to -196 ° C) of the materials, in order to reach their point of weakness, thus facilitating the grinding process. This technique is widespread in the pharmaceutical, food and plastic industries. It makes it possible to reduce hard-to-grind products or to optimize powder reduction, creating very fine particles up to 100 μm. The interest of this practice is to conserve vitamins, enzymes and many active ingredients in pharmaceuticals; to keep particle homogeneity and aroma of foods in the food industry and to grind difficult products without difficulty.
It is also used in various business sectors and applications such as: - In the agri-food sector, liquid nitrogen is used for rapid freezing (freezing). -In the IT field, liquid nitrogen is also used to cool processors in extreme ways to achieve overclocking records.