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ÿþf onddocindusbis - copie
Serving
lab,
plants
and
pilot
plants
3
Plants
for
a better
service
Val de Reuil
Paris
Milano
Marseille
Barcelona
Rodano
Peypin
Sabadell
Office
Plant
Warehouse
Rodano
Carlo Erba Reagenti SpA
Strada Rivoltana km 6/7
I-20090 Rodano (MI)
Tel. +39.02.95325.1
Val de Reuil
Carlo Erba Reactifs-SDS
BP 616
F-27106 Val de Reuil Cedex
Tel. +33 (0)2 32 09 20 00
Peypin
Carlo Erba Reactifs-SDS
Z.I. de Valdonne
F-13124 Peypin
Tel. +33 (0)4 32 41 41
Sabadell
Carlo Erba Reagents
Calle Filadors, 5º
08208 SABADELL
Tel. +34.93.693.37.35
Serving labs, plants and pilot plants
O
N
Cl
Quality
Health
Rodano plant (IT)
Group
Security
Environment
Certification Ethique
SA 8000
Val de Reuil and
Peypin plants (FR)
The guarantees of an ISO 9001 V2000 certified manufacturer
Carlo Erba Reactifs obtained ISO 9002 certification for the first time in 1992 in Rodano in Italy, and in
Peypin and in 1994 in Val de Reuil in France, then among the first companies to be certified ISO 9001
v2000 since october 2002.
All products are tested at each step in the manufacturing process ( visual examination, identification
by FTIR spectroscopy, GPC chromatography, FID, evaporation residue, water content....).
There is complete traceability.
The manufacturing and packaging processes eliminate the risk of cross contamination.
Your specifications become a quality protocole.
The audits from our customers attest to the reliability of our quality system.
An ISO 14001 manufacturer
The Val de Reuil and Peypin sites have also obtained ISO 14001 certification for
Environmental Management. The implementation of the ISO 14001 environment
management system guarantees your manufacturer respect environment.
Our sites are classidied as SEVESO due to their chemical activity. In order to prevent risk, we devoted to
implement an integrated management system (IMS) : Quality, Health, Safety, Environment. Safety of our
customers and our staff is our priority.
Sustainable Development
"Development that meets the needs of the present without compromising the ability of future generations to
meet their own needs" according to the Brundtland Report. Sustainable development is the integration of
three areas : environmental, social and economic. The policy of Carlo Erba Réactifs-SDS is accordint to this
concept : control of VOC emissions, waste sorting, accused of receiving orders by mail, consolidation of
shipments, dematerialization of invoices, ...
REACH - Registration Evaluation and Authorisation of CHemicals
After the coming into force, on 1 june 2007, of regulation REACH
n°1907/2006/CE, commonly known as REACH, the Carlo Erba Reagenti
Group has followed its development carefully, successfully meeting all
requirements set forth in the various stages of implementation.
Through its work of purification, packaging and formulation, Carlo Erba
Réactifs-SdS is regarded as a downstream user of substances and articles.
REACH
Regulation
For all substances we sell that can benefit of transition period, we are confident with our
suppliers of pre-registration thereof, with a deadline of 1 December 2008.
Meanwhile, we collect from our customers for each substance or preparation of a
volume greater than 1 tonne, the conditions of use and exposure to trace information
to the manufacturer to establish the CSA / CSR (Chemical Safety Assessment / Chemical Safety Report),
which must conclude for each identified use to a situation of risk adequately controlled.
This document will be mandatory for the registration of substances manufactured or imported in quantities
exceeding 10 tonnes per year for all customers who use a substance or preparation in quantities exceeding
1 tonne per year for substances subject to authorization. This collection of information must be completed
12 months before the expiry of the registration of the substance covered by the transitional regime, as
scheduled by the Regulations.
C L P : Classification, Labeling and Packaging
CLP is the transposition of the GHS (Global Harmonized System) for the European Community, Regulation 1272/2008, for labeling and classification.
Its implementation is slated for substances on 1 December 2010 and for mixtures 1 June 2015.
During the transitional period, the 2 labels will be valid. The 2 classifications appear on the MSDS till
2015.
The labeling of products at the international level will be harmonized at the level of :
Symbols of danger,
Notices,
Hazard : H sentences (Hazardous statement),
Safety advice : sentences P (Precautionary statement).
New labels according to CLP
Useful adress :
http://echa.europa.eu/home_en.asp : General website of echa
http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx : List of substances pre-registered
http://echa.europa.eu/consultations/authorisation/svhc_en.asp : Consultation substances SVHC
Quality
Control
Scrupulous compliance with good laboratory practice and constant
control over both raw materials and production processes guarantee the
high level of quality provided.
Specialized staff and advanced technology make the company's Quality
Control Laboratories the solution of choice to meet every need, both
internal and expressed by clients.
The certificate of analysis of each batch, if requested with the order, can be sent along
with the product.
All certificates of analysis can be download on our website www.cer-sds.com by providing product code and batch number indicated on the label of purchased product.
Informations on the certificate of analyse :
• Name of product and
respective grade, for RPH
products it includes the
idendification codes of the
Pharmacopeias for which
the product is guaranted
• Product code
Carlo Erba
Réactifs-SdS .
• Batch
number
which allows
all production,
alaysis and
packaging data
to be traced.
• P.M number
(Product method
number) which identifies the analysis
method used to check
product's compliance.
• Analytical results
including the real
values for the most
important assays.
• Sampling method.
• Reference material
used used in the analysis (if required by the
analysis method).
• Analysis approval
date.
• Production date.
• Batch expiry date :
expressed as
month/year.
Possibility of
validation
• Product specifications
including tolerances.
The data included in the certificate of analysis has been obtained using the most advanced analytical
methods, based on internationally approved methods and using recognized standards in all instrument
calibration/setting operations.
It is possible to analyse the product according to the notes from your own test laboratory.
Carlo Erba Réactifs-SdS launch
, a new range of
Raw Material for Pharmaceutical Use combining quality and regulatory requirements under the authority of the AFSSAPS.
Decree No. 2008-109 (published in the Official Gazette of 05 February 2008) relating
to raw materials for pharmaceutical use (MPUP) : modified code of public health by
requiring manufacturers or distributors of MPUP to report their activities to the
Afssaps. (Chapter III s.18).
Raw
material
for
pharmaceutical
use
For all components of the drug within the meaning of Article L. 5111-1:
- « All components of drugs ...»
The active substance,
The excipient,
The elements of formatting for use in humans or animals or to their being administered.
- The component drugs in human and veterinary use.
Through the implementation of this decree, the manufacturer or distributor must ensure that the final
destination of its products. As such, we must determine if materials sold to drug companies are for pharmaceutical use or not.
Carlo Erba Réactifs-SdS conducted the registration of sites involved in the manufacturing, distribution and
import from Afssaps :
Site de Val de Reuil (file 261)
Site de Peypin (file 262)
: not only a product....
products are solvents, salts, acid or basis mixes, meeting the requirements of Pharmacopeia monographs when it exists or those defined by the specifications of the customer. They fulfiIl the GMP
requirements for exicpients with a full documentation service :
Basis folder :
Follow the specifications as listed Pharmacopoeias
BSE/TSE certificate
Certificate of Compliance for residual solvents
Batch certificate of analysis
according to CPMP/ICH/283/95
Technical data sheet of the product
Certificate of Food Contact Packaging
Delivery in single bacth
MSDS
Declaration AFSSAPS
Traceability
Certificate of analysis of components if dissolution
Complete folder
: Basis folder along with :
Stability study
Change control (product, packaging, analysis)
Manufacturing process
The folder
Analytical procedure
Manufacturer name
, fee, renewable every 5 years, with updates every year for free.
Setting in
solution
In order to answer the needs of toxics handling, we built a workshop,
with the safety requirements for the operators. You can subcontract
us any operation with products classified as toxic and flammable.
toxics
We offer to produce for you :
Toxic raw material based mixtures,
Mixtures with toxic and flammable raw materials,
Toxic powders packaging.
A dedicated equipment :
Reactor of 2000 L in stainless steel 316 L with agitation shaft, propeller-driven filtration system racking
Reactor feed raw material liquid by pumping
In an ADF and secure environment :
Building on retention with the possibility of being cut off in case of toxic products overthrough,
Nitrogen inert reactor,
Self respiratory suit
Under the supervision of an outside operator
Decontamination shower airback,
Design allowing a complete cleaning.
Local Toxic
For various applications of 5 L to several tons, and to save you time, to
reduce risks associated with the preparation of these solutions, to provide a record label and safety data conform to current legislation,
Carlo Erba Reactifs-SdS offers to produce for you all kinds of solutions or
mixtures :
Taylor
made
mixtures
Acids mixtures,
Eluant, analytical, additive-modified, buffered or acidified phases,
Preparative eluant phases,
Reagents for biotechnology,
Titrated solutions,
Reagents for on-line analysers like TCO metres or silicemetres
We carry out a technical study and quotation according to your specifications and establish guaranteed
specifications.
Our know-how specific to your situation :
Titrimetry ( +/- 0.1% accuracy).The exact titre figures in the certificate
of analysis,
pH measure ( +/- 0.02 unity pH ),
Spectrophotometry,
Evaporation residue,
Water content,
Other specifications on request.
Quality protocoles for analysis : the choice of your analytical method
can be applied by our laboratory, with a protocole agreement.
Dedicated installation : mixer and filter
Taylor made packaging :
Stainless steel container from 5 to 200 litres
Drums from 25 to 250 kg
Containers from 500 to 3000 litres
Tanker from 5 000 to 30 000 litres
Reactor of 3 000 L.
Taylor
made
packaging
Industrial
Sourcing
From a few kilos to several tons...
Listed or custom produced, we pack your chemical products in
the container of your choice :
Bottle, barrels, bucket with total opening, reusable container,
In polypropylene, glass, stainless steel, Téflon ®,
From a few milliltres or milligrams to several tonnes,
Inorganic or organic products, solid or liquid,
Custom labelled,
Preweighing, pre-proportioning.
The packaged product is tested in conformance with the
requirements of our quality system.
Carlo Erba Réactifs-SDS can accomodate all of your
specifications in terms of analysis, labelling, packaging method
or filtration.
Industrial sourncing : an approach according to your situation
Filling a precise volume of a shuttle
For all your requirements from one kilo to several tones :
We identify the most economic and reliable source,
We check the products,
We can make custom packaging,
You receive the product in the packaging of your choice accompanied by our statement of analysis.
A wide range of products :
Inorganic, organic and fine chemicals, synthetic intermediates,
Photographic product, biochemistry,
Salts of metals and precious metals,
Irregular silica, spherical silica, modified silica,
Sieves, aluminas.
Carlo Erba Réactifs-SDS dispose de l'expérience,
des compétences, de la confidentialité pour la
purification de vos produits chimiques et la
régénération de vos solvants à façon.
Custom
Purification,
Recycling
Varied applications
Fine separation of solvents or solvent mixtures
Fine purification on fractionation column (raw materials or synthetic intermediates)
Dehydration, decolorisation
Solvents recycling
Purification of natural products
An adapted quality approach
We carry out an initial technical study to validate project
feasibility and establish your quotation. A pre-production
trial is then carried out.
Your products are received in barrels, reusable steel tanks
or container lorry.
They are purified or recycled according to your
specifications and dispatched in the packaging of your
choice, accompanied by their statement of analysis.
DIverse distillation equipment :
10 glass distillation columns with stainless steel
packed bed
Diameters from 0.15 to 0.30 m
33 to 100 theoretical stages under vaccuum
From 400 L batch to 2000 tonnes per year
continuous capacity
3 percolators (200L and 2 x 25L)
15 reactors from 100 to 7000 L
20 stainless steel tanks from 12000 to 30000L
150 stainless steel GRV
Filtration
Distillated columns
Percolator of 25L.
Possibility of delivering liquids filtered from 0.1 to 10 µm in bulk, for all your applications sensitive
to the particles.
Carlo Erba Réactifs-SDS offer stainless steel
container "reusables" for optimising solvent
quality and the management of packaging waste.
Shuttle
drums
from
5 to 200 L
Use this kind of packaging brings you :
Less handling and transfers thus security and manageability
Compliance with product quality : chemical compatibility same as in glass,
better than metal or plastic lost.
The shuttle container, whatever its size, contains a product of a single batch
which ensures a better reproducibility of results.
Each packaging is assigned to a product and a customer.
5 litres containers in plastic box :
The 4 x 5 litres box is used for the delivery and in return.
Weak clutter,
Very handy with its handle,
More safety for user,
Inviolable cap,
Possibility to put different delivery devices,
Certificate of analysis in each box.
25, 50, and 200 litres drums
Used in the laboratory and in production, steel drums can be stacked, mounted on steel pallet, ...
To connect 25 to 200 L stainless steel drums, we offer integrated draw-off equipment. They convey your
solvent towards the process, machine or intermediate packaging :
Under the action of an inert gas,
with stainless stell or Téflon® piping
Neutralising pollution risk,
Indicator noise
and visual
Pre-equipped with earthing on demand,
Possibility of adaptation with a level indicator or balance.
Solvent facility
Level detector
Nitrogen inlet
Fixed
drum
100L Drum
pallet welded
Shuttle
container
Example of 2 drums on line : 1 fixed and 1
shuttle with level detector
Containers
from
500 to
1000 L
Lost Container
PEHD 1000 L
the IBCs from Carlo Erba Réactifs-SDS grant :
A better monitoring of the batches. Specially they reduce the risk of cross-contamination and pollution.
Easier handling and sampling thanks to a wide choice of connections,
An improved safety for the operators as well as for the process by reducing the exposure to solvents,
No contaminated package waste to dispose of.
Transport, handling and safety are the main priorities in selecting the shape and
type of material to
use; last, but not least, is the cost of the package.
We can fill the containers with the most adequate quantity of product, for the production equipment.
Ex: 172 litres in a 200 L drum
500, 800 and 1000 litres containers
We offer you to fill up your own containers or to rent ours for a duration siutable to you:
IBCs, stainless steel / HDPE,
Stainless steel IBCs specific for ammonia
Non pressurizable IBCs (4 bars)
and to benefit our service :
Certificate of analysis of the container,
Representative sample to accompany the IBC,
Computerized tracing of the maintenance and
transport,
Total follow up of the product.
1000 L IBC
cylindrical
800 L container
specific for ammonia
Serving labs, plants
and pilot plants
CONTACT
To order,
to request product availability,
To have our price list,
For technical or regulatory informations,,
Contact customer service
For France :
02 32 09 2002
2003
2004
2005
2006
2007
For Spain :
+34.93.693.37.35
Fax number :
+34.93.693.37.73
Fax number :
02 32 59 11 89
For export :
04 42 32 4140
4165
Fax number :
04 42 32 41 51
For out-sourcing :
04 42 32 4965
Fax number
04 42 32 41 51
An email :
[email protected]
For informations on our catalogue or info sheet :
www.cer-sds.com