The pharmaceutical field is in full expansion, the production and values chains are undergoing changes that require the different actors to adapt. The pharmaceutical groups modify progressively their business model and focus their efforts on R&D by outsourcing one part of the API / HPAPI production to partners and / or CMO (contract manufacturing organization)
Their priorities are :
– No contamination
– Polyvalence due to the new contract frequencies, and therefore new product / processes
– Easy cleaning in order to guarantee the product quality at the end of the production
– Controlled efficiency to improve the productivity
De Dietrich Process Systems solutions meet perfectly the pharmaceuticals companies new expectations.
- In terms of material with the DD3009 enamel and its top class properties:Easy cleaning thanks to a very smooth roughness of 0,03 (0,8 for electropolished stainless steel), anti-adhesive properties, compliance with FDA requirements and without any risk of contamination of the final product.
Moreover, the DD3009 enamel benefits from a high corrosion resistance (acid, alkalin) and can be used across a wide range of temperatures and pressures
- In terms of reactors design and functionality:
On De Dietrich Process Systems reactors dedicated to pharmaceuticals industries (pharma reactor), the advantages are very significant:
– Reduction of the dead zone area thanks to specific design:
Shortened nozzle or block flange
Flat top cover
Inverted mechanical seal
OptiMix® baffle for a better cleanability
Fused glass solution (glass sandwiched into the manhole)
Bottom outlet valve with optimal draining
– Integration of instrumentation and functionalities allowing a very good media quality
Spray-ball for cleaning steps
Sampling at the heart of the process
Temperature and Ph probe to control the quality
– Contamination”s reduction:
External nickel coated parts to reinforce the mechanical properties avoiding the paints chips inside the reactor during manhole opening & closing
In addition to the equipment, CIP studies (Cleaning In Place) can be carried out by us, to guarantee that the spray-balls cover properly the reactor’s walls and to identify the shadow areas for a better control and cleaning.
These studies allow customers to define a quality and reproducible cycle, optimising the production steps and allowing to plan precisely the shutdown.
Therefore, De Dietrich Process Systems solutions and products aren’t only dedicated to chemical applications but are also ideally suited to meet pharmaceutical manufacturing standards.