Dispensing secondary pharmaceuticals

During the second part of manufacturing processes for pharmaceutical formulation, there is a paramount requirement to comply with current Good Manufacturing Practices (cGMP) regulations and maintain absolute quality assurance.

A key part of the secondary pharmaceutical manufacturing process will involve dispensing: the weighing and transfer of raw materials to containers for further processing and the similar transfer of processed powders to containers for onward shipment.

The demands of cGMP compliance dictate that these processes are carried out with zero risk of materials becoming cross contaminated, any escape of toxic substances or exposure to personnel.

Dec has developed different systems for easy and completely contained dispensing. These technologies eliminate pre-dispensing steps or intermediate packaging and also can be performed within a series of isolators that contain and integrate the entire process without the need for a costly series of clean rooms.

Dispensing requirements

Dec technologies allow emptying of different kinds of packaging or equipment, precise dosing and cleaning in place to be carried out by a single integrated system where containment is provided by specific equipment rather than dedicated environment.

The main sources of potential cross contamination are escape of materials into the surrounding environment and from the equipment and its surfaces used during ingredient material handling. A modern dispensing and transfer system will therefore assure containment at every stage of the process and allow for all contaminated containers and utensils to be thoroughly and easily cleaned to a validated standard after each process step.

Dec has developed different systems for easy and completely contained dispensing. These technologies eliminate pre-dispensing steps or intermediate packaging. Discharging, dosing, filling and cleaning in place can be carried out by a single system that eliminates the need for individual dispensing booths and personal protective equipment.

Dec Dispensing technologies

In a traditional dispensing set up, material is moved from storage and undergoes pre-dispensing handling in a sealed booth, using a glove box before being moved to a separate dispensing booth, also equipped with a glovebox, for processing and transfer to another container.

The Dec PTS Dispensing Concept eliminates for the need both sets of booths and glove boxes by transferring material directly and under containment via the Powder Transfer System (PTS) into the dispensing area, where it can be handled using the Drum Containment System (DCS). This is a stainless steel cylindrical unit with glass cover and two glove ports that can handle precise, contamination-free evacuation of drums in a far more economical way than conventional isolation systems and in inert atmosphere where required.

In a different configuration, powder can be sucked from bags at a Dec Isocharge station and/or a Sack Tip Cabinet through a sieve into a PTS Intermediate Bulk Container (IBC) Filler station.

A single Dec PTS dosing station can handle dispensing of multiple products, using different combinations of entry ports and pig switches. In the set up illustrated below, a single PTS unit is dispensing five different materials using three entries and two pig switches.

Alternatively, multiple PTS units can be used to handle separate products for faster throughput. The set up illustrated below is using an array of five PTS units to dispense five different powders.

The PTS is easy to integrate into production lines, with powders transferred automatically from drums, sacks, or from process equipment such as dryers or granulators. At the end of transfer cycle the system can be emptied completely and automatically for the next stage in production.

User Benefits

The Dec PTS Dispensing concept offers a series of clear user benefits:

• Elimination of costly and space consuming isolation booths and clean rooms
• Highly efficient transfer of powders and other materials
• Easy dispensing in precise quantities
• Full WIP, CIP facilities
• Protection from cross-contamination at every stage
• Full protection for production staff
• Full cGMP compliance
• Inert atmosphere capability for toxic and explosive powder handling
• High containment levels
• Minimal maintenance
• Space-saving with low height requirement
• Highly versatile and easily modified