Chemical Synthesis of APIs
In multi-purpose plants for the production of active pharmaceutical ingredients, flexibility has highest priority. Combinations of processing steps, wide variations in raw material and product qualities, and the need for contamination-free handling of powders continually pose new challenges to plant designers and builders. The basis for successful realisation of your facility lies in the multilateral expertise of our specialists. Linde's project experience include the design and construction of facilities for the production of active pharmaceutical ingredients, from kilogramme to multi-tonne scales. The spectrum extends from upgrading and expansion of single-product systems in existing buildings during ongoing production to new, multi-product, greenfield plants.
Scale-up from laboratory and/or pilot scale
Critical reaction stages such as low-temperature design of all reaction types and ranges for essential parameters (pressure, temperature, pH etc.)
Parameter-governed metering of reactants via closed systems
Use of optimal processes for crystallisation and/or precipitation
Separation (filtration, isolation, centrifugation) in combination with dryers of varying design (including packaging)
Linde observes strict occupational health and safety requirements as well as environmental safety standards in engineering plants to produce active ingredients. The target is the highest level of reliability and quality in every facility. Containment requirements are incorporated in the design and construction, where necessary up to OEL 5 or Protection Level 4 under the German Hazardous Materials Regulation.