Kremers Urban Pharmaceuticals, USA
MEDCO / Express Scripts, USA
Promega Corporation, USA
Purdue Heine Pharmacy, USA
Many processes in pharmaceutical manufacturing require tight control over humidity. Tablet coatings with aqueous solutions need precise humidity to ensure the coating does not dry too fast or too slowly.
As pharmaceutical facilities often need 24/7 environmental control, it’s important that the humidification system is designed specifically for the application. Standard heating, ventilating and air conditioning systems can rarely deliver the optimum conditions required. Due to the long operating periods, energy consumption and service requirements need to be considered.
Condair has successfully increased production output for numerous pharmaceutical manufacturers by up to 60% through working closing in coordination with the client’s research and development experts. By exploring production results at various humidities and then sustaining optimum levels indefinitely during manufacturing, reliable and environmentally friendly waste control can be achieved.
Regulations on accelerated or longterm stability testing mostly require humidity to be controlled within a tolerance of ±5%RH. If the condition of the atmosphere falls outside this window, it can result in a test having to be restarted. This is expensive and can even delay the launch of a new product.
Successful coating of a tablet largely depends on the composition of the tablet at the time of exposure to its coating. If the tablet’s surface is too dry, due to incorrect humidity levels, the coating will not adhere correctly. Likewise if the humidity post coating is not optimal, the coating may dry too rapidly, detrimentally affecting its properties.
Many cleanroom manufacturing processes require control over humidity. For instance, the printing of diagnostic strips using water based inks can require a high humidity of between 95-98%RH, ±1%RH. In such circumstances, when the optimum humidity is so precise, it is often not possible to maintain a whole room at such a close level so a contained micro-climate can be produced around an individual manufacturing process.
Fluid Bed Drying
Consistent and responsive humidity control in FBD processes results in the product’s moisture content reaching the target level more rapidly and with less wastage through over or under drying. Close control steam humidifiers running on pure RO water can provide ±2%RH and increase productivity when compared to more tradition live steam humidifiers mounted on fluid bed driers.