Registration Dossier

Administrative data

First-aid measures

Fire-fighting measures

Accidental release measures

Handling and storage

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

The intermediate is rigorously contained by technical means during its whole life cycle including:

Storage and sampling: the material, in its original packaging (kraft drums), is kept in our Warehouse until needed for production.
The Warehouse is designed and works according to GMP rules, validated by National Competent Authority (AIFA).
Packaging, safely closed, is duly labelled and is handled in accordance with internal Procedures available at site.

Loading into reactor: our Company operates batch process in discontinuous equipment, material loading into the reactor is made through manual operations. Only properly trained and authorized personnel handle the substance, handling procedures and control technologies (e.g. venting systems) are used in order to minimise emission and any resulting personnel exposure.
Substance-handling procedures are well documented and strictly supervised by the site operator.

Process equipment:
Cambrex Profarmaco Milano is well equipped to safeguard human health and prevent negative effects on the environment. The all facility has been designed and built according to the Italian laws and to the good engineering practices. In our organisation we have dedicated staff working full time on safety and environmental issues.
Cambrex Profarmaco Milano follows the Responsible Care principles.
We use reactors equipped with vapours extraction system and scrubbers.
Three different types of wastes may be generated: low contaminated water, highly contaminated liquids and gaseous emissions.
All these wastes are treated on site:
- the wastewater in our ecological department using a typical chemical, physical and biological process, from which we generate clean water and a sludge classified as non hazardous solid waste that is disposed off-site by authorised companies.
- the highly contaminated liquids are burned in our state of the art incinerator.
- all gaseous emissions are washed through a scrubber system and sent to the incinerator as combustion air.
Cambrex Profarmaco Milano is in compliance with all Italian safety, health and environmental laws and regulations enforced by different state and local authorities.

Cleaning:
cleaning and maintenance works are performed following internal procedures, in compliance with GMP, before and after each batch production.

Container disposal:
The empty containers (polyethylene bags), which are still contaminated with residual material are disposed off-site by authorised companies.

Stability and reactivity

Disposal considerations