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More opportunities per cubic meter.
BASF manufactures active ingredients and intermediates in
Evionnaz (Switzerland),
Saint-Vulbas (France),
Ludwigshafen and Minden
(Germany). cGMP-compliant reactor capacity of more than 600 m3 is available for complex chemical processes, enabling BASF to fulfill highly challenging project requirements.
The development laboratories in Ludwigshafen and Evionnaz are part of BASF’s research and development network. This brings together skills in organic synthesis, biotech and process technology from all four corners of the globe. Our chemists and engineers can rapidly scale up new syntheses for commercial production, or optimize existing processes for greater efficiency.
We can also leverage the unique resources of the BASF Analytics Competence Center to resolve any analytical challenges. We develop and validate new testing methods, or implement methods based on customer or pharmacopeia specifications.
We have state-of-the-art kilo labs in Ludwigshafen and Evionnaz. The equipment is suitable for all synthetic reactions, including high-pressure and low-temperature transformations. With multi-purpose reactor capacity of around 0.2 m³, production is generally up to 5 kg in four glass-lined reactors (20 to 100 l), at operating temperatures between –50 °C and +150 °C, and an operating pressure from 1 mbar to 6 bar.
cGMP-compliant pilot plants |
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At two pilot plants in Ludwigshafen and Evionnaz, we convert laboratory or kilo scale processes to commercial scale. Here we also manufacture new intermediates and active ingredients under cGMP in the volumes required for clinical trials. The plants are designed to handle complex, multistage chemical processes. Robust safety systems are in place for hazardous and toxic feedstock. The plants have the following features:
Pilot plant in Evionnaz (Switzerland)
- (Multiple-purpose) reactor capacity of around 5 m³
- Reactor lines of 100, 250, 630 and 1,000 l
- Approx. 80 % of the reactor capacity glass-lined, 10 % stainless steel and 10 % Hastelloy
- Seven glass-lined reactors (100 to 1,000 l) with an operating temperature of –30 °C to +150 °C, and an operating pressure of up to 6 bar
- One Hastelloy low-temperature reactor (630 l) with an operating temperature of –100 °C to +150 °C, and an operating pressure of up to 6 bar
- Two chambered glass-lined reactors (250 l) for special reactions with an operating temperature to +250 °C and an operating pressure up to 12 bar
- Two chambered glass-lined reactors and one stainless steel reactor (240 to 450 l) for phosgenation
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Dedicated cGMP-compliant equipment for crystallization, filtration, drying and filling in cleanrooms
Pilot plant in Ludwigshafen (Germany)
- (Multiple-purpose) reactor capacity of around 15 m³
- Chambered reactor lines of 100, 400, 630 and 1,000 l
- Approx. 50 % of the reactor capacity glass-lined, and 50 % Hastelloy
- Two Hastelloy low-temperature reactors (400 l, 1,000 l) with an operating temperature from –100 °C to +200 °C
- One glass-lined reactor (630 l) for phosgenation
- One glass-lined reactor (1,000 l) with an operating pressure up to 15 bar for hydrogenation and carbonylation
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Dedicated cGMP equipment for crystallization, filtration, drying and filling in cleanrooms under positive pressure with smooth walls and HEPA-filtered atmosphere
cGMP-compliant plants for commercial production |
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BASF has a total of 11 production plants at Evionnaz, Saint-Vulbas and Minden, with a cGMP reactor capacity of more than 600 m³. Reactor volumes ranging from 1,000 and 10,000 l mean exceptional versatility. Around one third of the reactors are stainless steel, the rest are glass-lined. The following facilities are available:
- A total of nine isolated reaction units for safe reactions with highly toxic substances (e.g. phosgene, phosphoryl chloride, cyanide)
- These chambers are equipped with anticorrosive glass-lined reactors (2,000 to 6,000 l) or Hastelloy reactors (6,000 to 8,000 l) and can handle operating temperatures from –20 °C to +160 °C and an operating pressure from 1 to 6 bar
- Two phosgene generators (capacity: 200 kg/h in Switzerland and 300 kg/h in France)
- Two low-temperature units with Hastelloy reactors of 630, 4,000 and 6,000 l with a total capacity of over 10,000 l, and an operating temperature range from -100 °C to +140 °C
- One reaction unit for azide chemistry with one glass-lined reactor (2,500 l), and an operating temperature from -20 °C to +160 °C
- Five glass-lined and two stainless steel reactors (2,500 to 6,000 l) for catalytic hydrogenation with an operating pressure range of 1 to 15 bar
Non-cGMP plants
In addition to the cGMP-compliant plants, BASF operates a variety of sophisticated multi-purpose assets in Ludwigshafen for non-GMP intermediates. A number of processes can be operated in these plants, including enzymatic reactions or high-pressure hydrogenation up to 200 bar.
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News |
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June 19, 2008:
Leading the way in respect of quality standards for pharmaceutical excipients
(english, deutsch) May 16, 2008:
Pharmaceutical excipient for instant-release tablet coatings approved in USA
(english, deutsch) April 30, 2008:
BASF sells its Shreveport site and related contract manufacturing business to Dr. Reddy's Laboratories
(english, deutsch)
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