Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

First-aid measures

Fire-fighting measures

Accidental release measures

Procedural and/or control technologies in case of accidents and in case where waste is generated are in place

Handling and storage

The substance in an intermediate isolated on-site and transformed into another intermediate to produce the final API. All operations are perfomed under strictly controlled conditions. The strictly controlled conditions are required both by the quality regulations (good manufacturing practices) and by the legal norms related with Health & Safety on the working places.

Process Sampling: Samples for IPC (in process controls) are taken by a sampling probe in a closed system.

Unloading of material: The unloading of AASA obtained by chemical reaction is done by centrifugation into double polyethylene bags inside PE drums directly connected to the discharging cone of the centrifuge (closed system). The centrifuge is placed inside a box with air local filtration and aspiration (AERON system with HEPA filter).

Drying of the material: The wet (from water) material is directly charged to the dryer through a hopper and dry for an established period of time at a defined temperature. The dry material is discharged via continuous liners (closed system) into PE drums fitted with another PE bag. The final sampling of dry AASA is done in a closed system using the same continuous liner system.

Analysis: Sample preparation and analysis are performed inside aspirated fume hood.

Storage and dispensing (Warehouse): The closed PE drums are stored in the warehouse. If necessary the weighing of the defined quantity of AASA for the subsequent process step is done inside a laminar flow/powder containment booth and HEPA filter (controlled area).

The technique is described in the internal SOP for the dispensing of the materials.

Loading of AASA into the reactor for the subsequent chemical reaction: AASA is a solid. Enclosed and vented charging system is used. The material contained into the closed drums is loaded directly into the reactor via pneumatic conveyor. In details the closed container of AASA is placed inside a box with local recycled filtration and aspiration (AERON system with HEPA filter); then the drum is opened and the material is transferred inside the reactor by a deep tube. The empty container is closed, removed from the box and sent to authorized external disposal.

Equipment cleaning and maintenance: In the case of cleaning and maintenance works, special procedures as described in the internal SOP and manufacturing methods such as purging and washing are applied before the system is opened and entered. The cleaning operation is done using closed systems.

Environmental monitoring of working area: All chemical synthesis are monitored by an external and approved firm according to a scheduled plan.

Transport information

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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

During all operations workers are equipped with the appropriate PPE (helmet, tyvek overall, chemical safety gloves, and full face powder mask with filter type ABEK P3 or alternatively connected to an external air source).

Periodical course for safe handling of materials and equipment, GMP procedure, emergency procedure for all operators and in case of new employees or change in the job or new products to be manufactured are performed. A specific SOP for the training of the personnel is in force.

All personnel handling the substance have access to MSDS of raw materials, intermediates and finished products.

Only properly trained and authorised personnel handle the substance

Stability and reactivity

Disposal considerations

Control of emissions:  

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

From the working environment: waste vapours are collected by pipes to the scrubber treatment. The waste scrubber solution is then disposed of by incineration.

Waste disposal:

Solids: The contaminated drums, PE bags containing residues of the substance and contaminated PPE are sent to authorized external disposal in accordance with local regulations.

Liquid : wastes from the synthesis and scrubbing solution are sent through pipelines (closed system) to the internal treatment by incineration and to the external authorized disposal.