Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

Fire-fighting measures

Accidental release measures

Handling and storage

The company produce APIs (Active Pharmaceutical Ingredients) and is inspected regularly by Italian Ministry of Health and FDA of USA. The strictly controlled conditions are required also by Good Manufacturing Practices to minimise cross contamination.

Sampling and dispensing procedures: in vented cabinets and Hepa-filters (controlled area)

Charging of materials:

Liquids: from tank farm, by means of pump and pipe (closed system); from drums by vacuum transfer

Solids: through manhole, with aspiration inside vessel and local aspiration around manhole

Reactions: all in closed system

Discharge of materials:

Liquids: by closed system

Solids: bulk containers for intermediate

Liquid wastes: by closed system to a tanks for external disposal

Control of emissions:

From reaction equipments: collected by pipes to a waste gas incinerator

From the working environment: collected by pipes to a wet scrubber treatment

Environmental monitoring of working area: performed by external and approved firm

In the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered; in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures; substance-handling procedures are well documented and strictly supervised by the site operator.

Transport information

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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

Training of personnel:  Periodical and repeated course for safe handling of materials and equipment, GMP procedure, emergency procedure

The personnel have access to MSDS of row materials, intermediates and finished products; only properly trained and authorised personnel handle the substance

Health management: the company strictly applies the legislation in force procedural and control technologies shall be used that minimise emission and any resulting exposure.

Stability and reactivity

Disposal considerations

Waste gas incineration: complete destruction of waste gases at high temperatures for a specified minimum residence time, as calculated by an engineer .

Condenser – low temperature devices through which waste vapours are sent causing them to liquefy and be collected.

Scrubber – number of types available. Usually packed columns around which an appropriate scrubbing solution circulates, as specified by an engineer. The waste vapours from a process and/or area are passed through the scrubber causing the fumes to be trapped in the scrubbing solution. The waste scrubber solution is then disposed of by incineration.