Secondary Pharmaceuticals
Manufacturing secondary pharmaceuticals typically includes the final formulation, so the need to meet the current Good Manufacturing Practices (cGMP) regulations and quality assurance is paramount. Conventional methodology is to use a series of clean rooms, which incurs significant construction and operational costs and can be problematical with new, highly toxic powders.
Alternatively, with careful thought and design, all areas of the plant can be contained by being placed into a series of isolators which contain and integrate the entire process.
Dispensing
Dec has developed different systems for easy and completely contained dispensing. These technologies eliminate pre-dispensing steps or intermediate packaging.
Emptying of different kinds of packaging or equipment, precise dosing and cleaning in place can be carried out by only one system, whose technologies allows the disposal of both, dispensing booths and personal protective equipment.
Blending
The mixing process is a critical step in reliable drug manufacture and a proper mixing technology must be chosen carefully.
Based on the PTS-Technology the Batchmixer (patented) was developed by Dec to mix active substances in one step in a self-contained system, which allows contamination free and product friendly mixing (no rotating mechanical parts) in batch mode under inert conditions offering the possibility to mix hygroscopic, oxygen sensitive or explosive powders.
Equipment Feeding
Pharmaceutical installations are designed to meet the requirements of the industry, including cGMP standards as well as the use of FDA approved materials. Dec Group specializes in supplying technologies focused on customized processes. Typical process applications include feeding and pneumatic transfer of active pharmaceutical ingredients (APIs), excipients and powders for milling/micronization, pharmaceutical extrusion, granulation, tableting and final pack-off. The PTS Powder Transfer System (patented) is the perfect solution to transfer (or discharge) powders in a contained manner for example into granulators, fluid bed dryers and containers.
Sampling
Sampling is still one of the most reliable ways to fulfill validation and quality assurance requirements. The sampling system MPTS Micro Powder Transfer System (patented) offers the possibility to take representative powder samples without mechanical devices directly from equipment even from a remote area. It has, therefore become easy to take samples from equipment with poor accessibility, e.g. for safety or space saving reasons.
