Registration Dossier
Registration Dossier
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EC number: 447-990-4 | CAS number: -
Guidance on Safe Use
Guidance on Safe Use
Administrative data
First-aid measures
Fire-fighting measures
Accidental release measures
Handling and storage
2. Operations description during the production process.
2.1 Raw Materials Preparation (ref. Procedure PMA 07.04.00)
The correct quantity of raw material to use in the manufacturing process is prepared by weighing it under the local exhaust.
2.2 Charging of Raw Materials in the synthesis reactor
Powders (ref. Procedure PDO 03.12.01)
- Solid raw materials are charged in the reactor through the hatch under the local exhaust.
Liquids (ref. Procedure PDO 03.13.01)
- Reactives stored in Drums
Reactives are charged in reactors through a dosing pump from their original container, in which they have already been weighed in the Raw Material preparation department.
- Solvents stored in Tanks. (ref. Procedure PDO 03.13.03)
Solvents are contained in tanks and are charged in the reactor through a fixed line equipped with a counter and with a reactor under a vacuum residue condition.
The solvent requests from the tanks are driven by the PLC (Process Logic Control) System, through a remote control. The operator acts on the main control panel. The whole system is closed.
Before the solvent request, the operator enables the receiving reactor to receive the solvent, actioning one or more valves, to allow the operation. The operator then dials on the display the correct type of solvent requested in entrance (the choice is related to the lines entering in the reactor) and the requested quantity. (ref. Procedure AEL 00.00.13).
2.3 Reaction Solution transfer from reactor to reactor. (ref. Procedure PDO 05.00.02)
The whole process takes place in a continuous and closed system. Inside the system a liquid flow is generated caused by a pressure gradient. This pressure gradient is generated by a vacuum system present on the receiving reactor and by generating pressure on the starting reactor.
2.4 In process controls – Sample Analysis (ref. Procedure PDO 06.13.01)
The synthesis reactor has a valve for sample withdrawal.
Sampling is done by authorized personnel wearing adequate protections.
The samples withdrawn are then analysed in laboratory only by qualified personnel.
(ref. Procedure, CQA 02.00.00)
2.5 Discharge of product from synthesis reactor and packaging (ref. Procedure PMA 05.03.01)
The finish product is discharged automatically, in polyethylene bags put inside a fiber drum, under a laminar flow hood.
3. Storage (ref. Procedure PMA 06.04.00)
The product, after been packaged, is stored in a specific area of the warehouse waiting for the QC approval.
4. Intermediate transformation in the next synthesis process.
In the next synthesis process the intermediate enters as a raw material. It is charged in the reactor under the local exhaust and then transformed in another product through a condensation reaction. (Acylation reaction).
5. Description of Control Technical Measures of the Workers Exposure.
(ref. Procedure RRR 00.20.04, RRR 01.02.04)
The whole process is done in a closed and continuous system, with occasional controlled exposure.
As already mentioned, the charging and discharging operations are performed with the use of the local exhaust. Beside the workers have the individual protection devices and the workplaces are periodically controlled for both the workers exposure to organic volatile substances and to the powder levels.
(TLV-TWA determination).
6. Description of Individual Protection Devices.
….(ref. Procedure ISGS 15.04.01.00, ISGS 15.04.02.00, )
For all the operations above mentioned, in paragraphs 2, 3, 4, the workers use suitable individual protection devices. (gloves, protective glasses, masks with suitable filter, overalls).
7. Abatement systems description. (ref. Procedure ISGA 50. 04.06.04/1)
The production plant is connected to a local abatement system.
The hood used for the preparation of raw material has a dishes scrubber.
The local exhausts have dishes scrubber or scrubber with filling bodies.
The vacuum pumps, the centrifuges, the exhaust solvent tanks have a cryogenic equipment and active carbons or a water scrubber.
8 Waste Water Treatment, Solid Waste Treatment (ref. Procedure ISGA 50. 04.06.04/3)
Liquids (Waste from Organic Chemical processes)
Organic solvents, washing solutions and waste waters are all disposed as dangerous special waste.
Solids
Containers with residue of dangerous substances inside or contaminated by these substances, for example the individual protection devices or adsorbent materials, are disposed as special dangerous material.
9. Cleaning of the Production Plant (ref. Procedure PDO 04.11.01, PDO 04.00.02).
The production plant, at the end of the production, is always subject to a series of washes before re-starting the manufacture of another product.
10 Special Procedure adopted in case of leakages
(ref. Procedure PSGS 15.06.01.04)
Any product loss in the synthesis department, as liquids or powders spills, are not to be considered dangerous for the external environment because collecting ducts are present; they collect and convey these substances to the waste water treatment.
In all the areas in which there is a risk of spillage there are present drums containing materials with a high absorbent capacity to soak up any leakage.
11. Workers Training (ref. Procedure CQA 02.00.00)
Only authorized and qualified personnel can enter and work in the Production department and in the Warehouse.
12.Measures of risk management adopted in accordance with the Legislative Decree 81/08
(Security)
With the entry into force of the above mentioned decree, our company has adapted to the obligation of the update of the documentation related to the company security.
This, with regard to the provisions relevant to risks evaluation, lead to the preparation of the Risks Evaluation Document. In this document, all the risks considered in the above mentioned decree, have been evaluated.
13. Measures of risk management adopted in accordance with the Legislative Decree 152/06
(Environment)
Our company acts applying measures of risk management in compliance with the above mentioned decree.
2.1 Raw Materials Preparation (ref. Procedure PMA 07.04.00)
The correct quantity of raw material to use in the manufacturing process is prepared by weighing it under the local exhaust.
2.2 Charging of Raw Materials in the synthesis reactor
Powders (ref. Procedure PDO 03.12.01)
- Solid raw materials are charged in the reactor through the hatch under the local exhaust.
Liquids (ref. Procedure PDO 03.13.01)
- Reactives stored in Drums
Reactives are charged in reactors through a dosing pump from their original container, in which they have already been weighed in the Raw Material preparation department.
- Solvents stored in Tanks. (ref. Procedure PDO 03.13.03)
Solvents are contained in tanks and are charged in the reactor through a fixed line equipped with a counter and with a reactor under a vacuum residue condition.
The solvent requests from the tanks are driven by the PLC (Process Logic Control) System, through a remote control. The operator acts on the main control panel. The whole system is closed.
Before the solvent request, the operator enables the receiving reactor to receive the solvent, actioning one or more valves, to allow the operation. The operator then dials on the display the correct type of solvent requested in entrance (the choice is related to the lines entering in the reactor) and the requested quantity. (ref. Procedure AEL 00.00.13).
2.3 Reaction Solution transfer from reactor to reactor. (ref. Procedure PDO 05.00.02)
The whole process takes place in a continuous and closed system. Inside the system a liquid flow is generated caused by a pressure gradient. This pressure gradient is generated by a vacuum system present on the receiving reactor and by generating pressure on the starting reactor.
2.4 In process controls – Sample Analysis (ref. Procedure PDO 06.13.01)
The synthesis reactor has a valve for sample withdrawal.
Sampling is done by authorized personnel wearing adequate protections.
The samples withdrawn are then analysed in laboratory only by qualified personnel.
(ref. Procedure, CQA 02.00.00)
2.5 Discharge of product from synthesis reactor and packaging (ref. Procedure PMA 05.03.01)
The finish product is discharged automatically, in polyethylene bags put inside a fiber drum, under a laminar flow hood.
3. Storage (ref. Procedure PMA 06.04.00)
The product, after been packaged, is stored in a specific area of the warehouse waiting for the QC approval.
4. Intermediate transformation in the next synthesis process.
In the next synthesis process the intermediate enters as a raw material. It is charged in the reactor under the local exhaust and then transformed in another product through a condensation reaction. (Acylation reaction).
5. Description of Control Technical Measures of the Workers Exposure.
(ref. Procedure RRR 00.20.04, RRR 01.02.04)
The whole process is done in a closed and continuous system, with occasional controlled exposure.
As already mentioned, the charging and discharging operations are performed with the use of the local exhaust. Beside the workers have the individual protection devices and the workplaces are periodically controlled for both the workers exposure to organic volatile substances and to the powder levels.
(TLV-TWA determination).
6. Description of Individual Protection Devices.
….(ref. Procedure ISGS 15.04.01.00, ISGS 15.04.02.00, )
For all the operations above mentioned, in paragraphs 2, 3, 4, the workers use suitable individual protection devices. (gloves, protective glasses, masks with suitable filter, overalls).
7. Abatement systems description. (ref. Procedure ISGA 50. 04.06.04/1)
The production plant is connected to a local abatement system.
The hood used for the preparation of raw material has a dishes scrubber.
The local exhausts have dishes scrubber or scrubber with filling bodies.
The vacuum pumps, the centrifuges, the exhaust solvent tanks have a cryogenic equipment and active carbons or a water scrubber.
8 Waste Water Treatment, Solid Waste Treatment (ref. Procedure ISGA 50. 04.06.04/3)
Liquids (Waste from Organic Chemical processes)
Organic solvents, washing solutions and waste waters are all disposed as dangerous special waste.
Solids
Containers with residue of dangerous substances inside or contaminated by these substances, for example the individual protection devices or adsorbent materials, are disposed as special dangerous material.
9. Cleaning of the Production Plant (ref. Procedure PDO 04.11.01, PDO 04.00.02).
The production plant, at the end of the production, is always subject to a series of washes before re-starting the manufacture of another product.
10 Special Procedure adopted in case of leakages
(ref. Procedure PSGS 15.06.01.04)
Any product loss in the synthesis department, as liquids or powders spills, are not to be considered dangerous for the external environment because collecting ducts are present; they collect and convey these substances to the waste water treatment.
In all the areas in which there is a risk of spillage there are present drums containing materials with a high absorbent capacity to soak up any leakage.
11. Workers Training (ref. Procedure CQA 02.00.00)
Only authorized and qualified personnel can enter and work in the Production department and in the Warehouse.
12.Measures of risk management adopted in accordance with the Legislative Decree 81/08
(Security)
With the entry into force of the above mentioned decree, our company has adapted to the obligation of the update of the documentation related to the company security.
This, with regard to the provisions relevant to risks evaluation, lead to the preparation of the Risks Evaluation Document. In this document, all the risks considered in the above mentioned decree, have been evaluated.
13. Measures of risk management adopted in accordance with the Legislative Decree 152/06
(Environment)
Our company acts applying measures of risk management in compliance with the above mentioned decree.
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