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The Challenges and Opportunities for High Performance Drying of Pharmaceuticals

The Challenges and Opportunities for High Performance Drying of Pharmaceuticals

 

Drying specialist Hosokawa Micron B.V. offer competitive edge drying technologies and processing options for the production of complex pharmaceutical products.

Triggered by policy driven changes in healthcare spending that demand cost efficiencies and timely routes to market, drug manufacturers are reviewing new technologies in a bid to meet demands across a range of complex pharmaceutical products.

André Hermsen, Manager Team Pharma, Hosokawa Micron B.V., says, “We can offer multiple solutions for FDA, cGMP and GAMP standard, pharmaceutical drying, by a range of drying technologies including vacuum and active freeze drying. With a portfolio of new developments in CIP and aseptic design, data acquisition and control systems and operational choices that can influence end product characteristics we are the ‘go to choice’ for manufacturers keen to benefit from our combined technical expertise and pharmaceutical processing know-how - from R&D through to and full production plant.”

Here André reveals how Hosokawa Micron B.V. technologies are proving popular in the battle for more competitive pharmaceutical production. “We work closely with customers to determine how we can offer the best individual processing solution, regardless of capacity or product and process requirements. One of our most recent projects included several batch drying systems, in China, for drying Cephalosporin under sterile conditions”.

Conductive Drying

A gentle drying method suited to heat sensitive products, conductive drying, particularly under vacuum evaporates liquids at a low temperature leaving powders with less than 1% moisture. Often used in conjunction with an upstream centrifuge delivering powders with 20-30% moisture content, to a conical vacuum dryer.

“Hosokawa Micron B.V. are well known for their Nauta conical vacuum dryer and have recently introduced a conical paddle dryer to their pharmaceutical range. The Nauta dryer mixes by gravity to produce high quality particles which because of low agitator shear are not rounded or damaged, this action has the benefit of low energy consumption. The final product is lump free in contrast to tumble dryers which form snowball like lumps, increasing drying time.

The conical paddle dryer (CPD), has a central shaft with paddles that keep the total batch moving, add shear into the mix and overall this offers a higher heat transfer coefficient. With a lower build height the CPD can be used in restricted spaces. If your product goes through a sticky phase, we would however, suggest choosing the Nauta dryer but this can best be advised after a test with your product in our test factory.

Both vacuum drying types are completely closed making them suitable for pharmaceutical production, no potentially toxic gas can escape to the environment and no air or bacteria can enter to contaminate the product.”

Aseptic Processing

The fully contained systems allow for aseptic processing, spray nozzles enable effective CIP cleaning and SIP is achieved through pressurized steam or vaporized cleaning agents as required.

Sanitary design and engineering principles include sterilizable, dynamic seals; no lubricants in the product zone; polished, crevice free dryer internals for easy cleaning plus bottom valve discharge with no dead zone for complete vessel emptying.

Today’s Nauta conical vacuum dryer designs no longer feature a bottom screw support making removal of the orbital arm from the top easy and with no requirement for access into the vessel. To complete its full cGMP design the dryer and its filter are equipped with fixed-mounted spray balls and spray nozzles for CIP/SIP.

Controls and Data Acquisition

For automated systems we can offer a range of control and data logging data acquisition options which deliver a range of reporting solutions and advisory selections designed to support cGMP, GAMP 5 and 21 CFR Part 11 compliance requirements and maintain smooth plant operations.

Try Before You Buy

Hosokawa Micron B.V. has its own testing and development centre in Doetinchem, the Netherlands. It offers unique possibilities for testing your product to determine the most efficient process, system or plant prior to final design. We can provide laboratory as well as production-sized trials.

“Whether you wish to test a single machine or a complete powder processing system, the same skilled and experienced staff are here to help ensure that your requirements are met, and that you are entirely satisfied with the results”, confirms André.

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