ÿþf onddocindusbis - copie
Transcription
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