euros - quality chemicals · iso quality system integration production according gmp’s 2000 2004...
TRANSCRIPT
The activity of Quality Chemicals SL is the development and manufacturing of inorganic chemical products, solvent purification and reagents for synthesis
Company
Probus launching
1929
E.Merck Group integration
Spin off Quality Chemicals SL
1997 1978
Quality Chemicals comes from the first spanish company to produce pure chemical products Probus
Afterwards integrated in E. Merck Group
Through a Spin off, Quality Chemicals was launched in 1997, by the management team
History
Quality Chemicals SL launching
1997
Factory of Esparreguera inauguration
Purity Chemicals SL launching
ISO Quality System integration
Production according GMP’S
2011 2000 2004 2010
First goal was the building of the factory set in Esparreguera, with suitable facilities to produce high pure products
In 2004, Purity Chemicals was launched in Venta de Baños (Palencia)
Integration of both companies in ISO, integrated quality system
Production according GMP
Developing
General Manager
Administration
Human Resources
Commercial Purchasing Quality Unit
Quality Control R+D
Operations
Quality Chemicals
Production Logistics
Purity Chemicals
Production Logistics
Organization
Located in the industrial area of Barcelona Next to A-2 Motorway Integrated in the main European means of
transport, both road and rail
Location
Surface 6.000 m2
Warehouses 1.500 m2
Manufacturing 1.800 m2
Laboratory 300 m2
Services 500 m2
Offices 300 m2
Facilities
Inox Reactors 20.000 Lts. Enamel Reactors 6.500 Lts. Glass Reactors 200 Lts. Centrifuges 3 un.
Fluid bed dryers 1.000 Lts. Static dryers 3.000 Lts. Mills 3 un. Distillers 3 un.
1.500 Tm. Annual Production
Production
Warehouses in accordance with Chemical Products Storage regulations
Tank storage Warehouses separated according to hazard.
Toxic. Flammable.
Storage
Inorganic compounds Acids and alkalis Solvents Solutions and
customized products
Manufacturing on demand (custom manufacturing) under confidentiality agreement
Products
Spectrophotometer AA Spectrophotometer ICP Spectrophotometer UV Spectrophotometer IR Gas chromatography
Chromatography HPLC Thermogravimetric
analyzer Colorimetric determination Melting point determination Microbiology lab.
Laboratory
Offices
Commercial Dep. Commercial team Customer Assistance
Purchasing Dep. Human Resources Financial Dep. Management
Launched in 2004 by the same partners as Quality Chemicals SL
Located in Venta de Baños (Palencia) Capital stock (nominal) 300.000 Euros
Company
Surface 8.000 m2
Warehouses 500 m2
Manufacturing 1.000 m2
Laboratory 100 m2
Services 400 m2
Offices 50 m2
Facilities
Inox Reactors 15.000 Lts. Enamel Reactors 9.000 Lts. Centrifuges 2 un.
Fluid bed dryers 200 Lts. Static dryers 2.000 Lts. Conical dryier 3.000 Lts. Mills 1 un.
1.500 Tm. Annual Production
Production
Nitrates: Sodium Potassium Copper Calcium
Phosphates: Sodium Potassium
Sulfates: Sodium Potassium Iron
Chlorides: Magnesium Manganese Iron
Acetates: Sodium Magnesium
Inorganic compounds manufacturing
Isolated premises to meet ICH-Q7 – EU-GMP part II regulations
Controlled environment room for packaging
Isolated Centrifuges
Isolated Fluid bed dryer
Isolated Static dryier Drying and packaging in a
closed system Validation and fabrication
protocols in accordance with ICH-Q7 – EU-GMP part II regulations
Production
Isolated premises to meet ICH-Q7 – EU-GMP part II regulations
Controlled environment room for packaging organic solvents
Isolated Distillers
Validation and fabrication protocols in accordance with ICH-Q7 – EU-GMP part II regulations
Production
Technology Transfer Report Validation of analytical methods Stability tests according to ICH Q1(R2)
Laboratory
ACS – Use in laboratory reactives AI – Use in instrumental analysis – UV – IR-HPLC Pharmacopeia's PH-EUR – USP Food industry – FCC – AL (EU 231/2012) Specific standards – ASTM
Norma
Laboratory Reagents Feed Food
Nutraceutics Dietary supplements Dairy industry Brewery industry Meat industry
Veterinary
Pharma industry GMP-Manufactured GMP-Conditioned Oral care Contact Lens care
Cosmetics Chemistry
Electronics Clinical Chemistry
Markets by sectors
ISO-9001-2000 certificate in February 2004
ISO-9001-2008 certificate in February 2010
Integration of Purity and Quality in a single quality system ISO9001-2008 in February 2010
Certification ISO-14000 in March 2011
GMP certificate in May 2014
Certificates
Our future is to be at the service of our customers To offer products manufactured under GMP’s
procedures to be integrated in the DMF of our customers
To grow in markets with high demand of quality
Future