CONTROLLED EQUIPMENT AND ENVIRONMENTS

(ZAC)

Control / Qualification

  • Barometric and climatic measurements
  • Airflow measurements (flow, uniformity, laminarity, THR)
  • Integrity and airtightness testing of air filtration systems.
  • Particulate control
  • Qualification of water treatment and distribution facilities.
  • Compressed air control

Barometer and climatic measures:

Objectives:

Check the capacity of the installation, to maintain the differential pressure of the air between the room and its environment.
Perform the climate measurements: temperature, relative humidity, absolute humidity and dew point of a room.

Equipements:

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)

Objectives:

Measurement of the average speed of a HEPA filter and calculation of the flow of blow or extraction.
Check the flow rates (blown flow and return flow) of the hourly renewal rate.

Equipements:

The flow measurements are directly carried out using a barometer thanks to its interchangeable heads. A barometer allows reliable, fast and accurate measurements.
A smoked generation unit used for visualizing air flows.

 TSI  Balometer

 

Repositories: ISO 14644-3; GMP, NF 90-351 NF 12469

TEST OF INTEGRITY AND SEALING OF AIR FILTRATION SYSTEMS:

Objectives:

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.

Equipements:

Aerosol + DI-Etyhl-Hexyl-Sebacate Generator DEHS.
Isocinetic Rectangular Probe.
TSI particle counter.

 

 

Repositories :: ISO 14644-3, GMP in rigor, NFEN 1822

Aerobiocontamination and surface control

Objectives:

Removal of air and surface on the culture medium to determine the state of cleanliness of equipment.

Equipements:

Bio-collector + Impactor

Repositories  : ISO 14698-1 GMP in rigor, NFS90-351

PARTICULATE CONTROL 

Objectives:

Measurements of the dust level of a room or equipment.

Equipements:

TSI particle counter

Repositories: ISO 14644-1, GMP in rigor, NFS 9035)

Mapping and homogeneity of temperature-controlled enclosures

objectives:

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

objectives:

control of the production and distribution systems of purified water.

Analysis  :

- Measures of microbial contamination.

- Limit test of nitrates and heavy metals.

- Oxidizable substances.

- Bacterial and fungal identification.

- Measurement of conductivity.

- Determination of bacterial endotoxins.

Implementation  :

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.
By placing itself at the pressure of the compressed gas equipped with a flow meter, it guarantees a constant flow whatever the pressure of the gas.
The agar plates are then incubated and reared in the microbiological laboratory according to GMP and ISO 17025.

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.
For the oil content the oil impactor will be preferred over the reaction tubes because it allows the measurement of all types of oils, regardless of their category or viscosity.

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 ...)

Equipements:

TSI multi-function device

TSI Bolometer

DRAGER smoke tube

Générateurthermique

Diluter + impactor

TSI meter

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.

Control of Liquid Nitrogen



Prestations