Pharmaceutical Industry

Mixing, Homogenizing, Coating, and Drying

As a supplier of machines and installations to the pharmaceutical industry, we ensure that these comply with current GMP regulations and are FDA compliant. Furthermore, we guarantee that they are delivered with all required certification and help our customers to conduct risk analyses (RA). We take our service to the next level by supporting the procurement and validation process with our FAT and SAT protocols and with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). We also conduct operator training and carry out plant maintenance.

Whatever your requirement – precise mixing processes, gentle vacuum drying of APIs, homogenizing or granulating – AVA puts its know-how and experience to work for you.

Drying of APIs

AVA HVW-VT series drying mixers with their sophisticated vertical design offer top-of-the-line, highly reproducible product quality, maximum safety, and utmost ease of operation. The vertical drying mixers are equipped with a top-driven, rotating and self-centering helix with bearing and seal which are external to the product chamber. Contamination of high-quality APIs is thus reliably prevented. The large heating surface implemented as a heated double jacket, as well as the optionally heated shaft and helix, ensure optimal heat transfer, meaning the product is heated up quickly and uniformly. The vacuum lowers the boiling point and accelerates drying. The product is continuously homogenized in the vessel during the drying process, with no temperature or moisture gradient in the product at any point. After drying, the product is discharged into the cone outlet via a ball segment valve. To prevent issues such as cross-contamination, CIP cleaning nozzles ensure coverage of the entire interior and the filter housing when the machine is closed. With GMP designs and the use of FDA-compliant, pharmaceutical-compliant materials and seals, the highest production reliability is ensured.

An interesting alternative is the horizontal AVA HTC-VT series drying mixers with one-sided shaft bearing and large inspection door. The mixer blades are welded to the shaft and span the entire interior of the double jacket-heated drying mixer with no cavity. The shaft is sealed with gas-cooled AVA lip seals. Because it is mounted on one side in a reinforced gear, the drive unit can be placed outside the clean room while the FDA-compliant active unit performs its mixing task inside the clean room. On the opposite side, there is a large inspection door. It is suspended sideways, heated separately, and provides optimal accessibility to the interior.

Containment Systems for Pharmaceutical Production

Even base-version AVA conical mixers and drying mixers offer good containment conditions. The vessels are self contained. The mixing shaft bearing and seal is outside the product chamber. The customer can choose from various GMP-compliant, cavity-free mechanical seals. Accessories such as pressure transmitters, temperature probes, gas and CIP nozzles, samplers, and more, can be implemented and installed flush with the wall and cavity free. High-quality AVA flaps or ball segment valves are also easy to clean in their entirety without the need to disassemble them.

If feeding and discharge are carried out via double flaps, which currently achieve containment levels below 1 µg/m³, highly active ingredients can be fed and discharged under clean room conditions. An example: APIs together with auxiliary substances are filled under a closed hood into a transfer vessel to which the passive flap of a double-flap system is attached. The vessel is docked onto the active flap on the mixer. The valve is then opened, allowing the contained passage of powder into the mixer. When the transfer is complete, the valve is closed and the vessel undocked, leaving the two external valve surfaces clean. Once the substances have been mixed or dried, they are similarly discharged into the transport vessel to be used for the next process step. The same system and a drying mixer attached to a pivoting lifting column can be used to discharge products from a centrifuge, dry them, and fill them into transport vessels under contained conditions. This AVA lifting column system also provides the advantage that users can ideally access all product-wetted parts for easy inspection and cleaning.

AVA Vertical Mixers for Small API Throughputs

In addition to homogenizing, AVA vertical mixers are highly suited for use as bunker mixers between an inverting filter centrifuge mixer and a fluidized bed dryer. The centrifuge is specially designed for rapid filtration of small batches. A fluidized bed dryer typically requires larger batch volumes to operate efficiently. Therefore, the centrifuge first takes small amounts of the active ingredient, which has the consistency of a pasty mass, filters them, and empties them into the AVA vertical mixer. The AVA mixer moves the product slowly to avoid compactions. As soon as a sufficiently large batch volume is reached (detected by weighing cells), it is emptied into the fluidized bed dryer. The process thus takes place in semi-batch mode. In this process, the AVA vertical mixer forms the ideal bridge between the small centrifuge batches and the fluidized bed dryer, which requires larger volumes.

Deciding Facts – Pharmaceutical Industry

  • Fast mixing times and high mixing quality for consistently reproducible mixtures
  • Simple and thorough CIP cleaning systems
  • Cavity-free design
  • Thermal reacting and drying processes even under pressure and in a vacuum
  • Spray nozzles for homogeneous coating
  • Large heating surface thanks to double jacket, shaft, and agitator heating
  • FDA compliant, validated designs
  • Containment systems available

AVA believes in the virtue of flexibility. This is why our products address all industry sectors and meet any process requirement. Our offering includes horizontal and vertical technology, guaranteeing the best fit for your specific application. Also take advantage of our test center to see for yourself which technology best suits your needs.

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