Registration Dossier

Administrative data

First-aid measures

Eye Contact:
Immediately flush eyes with copious amounts of water for at least 15 minutes. If irritation persists, seek medical attention.

Skin Contact:
After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.

Inhalation:
Allow the victim to rest in a well ventilated area. Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. In severe cases or if symptoms persists, seek medical attention.

Ingestion:
Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

Fire-fighting measures

Extinguishing media:
In case of fire use water, chemical type foam, carbon dioxide, dry chemical. Prevent run off of water from entering drains

Hazardous combustion products:
The substance evolves toxic fumes due to the presence of CO, CO2, NOx, HBr

Fire-fighting equipment:
Respiratory and eye protection for fire-fighting personnel

Accidental release measures

Person-related safety precautions:
Wear protective equipment
Keep unprotected persons away

Measures for cleaning / collecting:
Damp down to avoid dust generation
Do not allow to enter public sewers and watercourses
Sweep or shovel-up spillage and remove to a safe place
Absorb spillage in earth or sand

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 procedure: 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.

Transport information

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Marine transport (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 MDS 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;
only properly trained and authorised personnel handle the substance;
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.

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.