In the intricate landscape of pharmaceutical manufacturing, a new challenge is fast emerging: Aseptic Powder filling. Aseptic powder filling is a critical step in pharmaceutical production, particularly for medications that require sterile administration such as reconstitution products. It creates challenges not seen in other sterile applications. While the primary goal is to maintain an environment free from microbial contamination, safeguarding the integrity of the product additional challenges await. Powder is not a liquid and thus does not always exhibit fluid like properties. This can be a problem when you are trying to get small amounts of powder into specific drug container formats including syringes and cartridges. When we say small, we mean really, really small that is when compared to liquids. Dose sizes are often a magnitude 1,000 times lighter than liquids. This means both machine noise and more importantly air velocity – an absolute requirement to create a compliant aseptic space – can cause headaches to dosing small powder quantities.
Key Principles of Aseptic Powder Filling
1. Containment and Isolation
One of the fundamental principles of aseptic powder filling is the meticulous containment and isolation of the process. The handling and dispensing of powders occur within a controlled, enclosed environment, minimizing the risk of external contaminants. This is especially crucial when dealing with potent or sensitive pharmaceutical compounds. Equipment in 3P Pharma Equipment’s ‘Discover Range’ can be used inside existing isolators, RABS, LAF’s and down-flow booths. Powders often pose the additional challenge of requiring containment to protect the operators. In non-sterile production, this relies on the use of negative pressure isolators to handle the potent powder, ensuring hazardous material does not escape the immediate process area and become a risk to the operators. In aseptic processing the situation is reversed with positive pressure isolator systems being employed to prevent the ingress of foreign particles into the process space which could affect the sterility of the line. There are various approaches to combatting this challenge in isolator design including the use of dual wall systems and pressure sinks between chambers.
2. Sterilisation & Cleaning Techniques
Sterilisation is essential to aseptic processes. Effective sterilisation techniques, both of equipment and the surrounding environment, ensure the elimination of microorganisms. Common methods include vaporized hydrogen peroxide (VHP) and gamma irradiation, which guarantee a high level of sterility necessary for aseptic powder filling. Powder has a tendency to get airborne, this means it can coat lots of surfaces within an operating space and can penetrate seals over time. A full wash down procedure is necessary to clean the line prior to the sterilization process. This can be complicated further if handling highly potent compounds, the wash down process must be conducted without exposing the operators to the potential hazardous environment. If a wet in place (WIP) or clean in place (CIP) process is not possible, this will mean the full gowning of operators in suitable PPE to clean down the equipment, this can add a lot of time and cost to the total cost of processing a batch. If the process line is opened to the process suite, then the full room will require cleaning.
3. Closed-System Processing
Closed-system processing is an integral part of aseptic powder filling. The objective is to minimise human intervention during the filling process, reducing the risk of contamination. The closed-system approach, implemented through advanced engineering and automation, plays a crucial role in achieving and maintaining sterility.
Techniques for Aseptic Powder Filling
Gravimetric Powder Filling
Gravimetric filling relies on weight measurement to control the amount of powder dispensed into a container. The system continuously monitors the weight using a scale or weigh cell, halting the filling process once the desired weight is achieved. Gravimetric filling excels in accuracy, making it suitable for applications with stringent dosage requirements. 3P’s Gravimetric Filler has been designed with pharmaceutical applications in mind, enabling handling of ultra-low-dose and high-potency APIs, alongside the increasing need for high-accuracy, precision powder filling in clean-room and sterile environments for inhalation, parenteral and oral solid dose (OSD) applications. This technology is incredibly adept at handling challenging powders in challenging conditions. There are current working examples of this technology employed in dose cohesive static powders down to 10mg into a plastic device in very low relative humidity in an aseptic environment, here at 3P innovation, we are not aware of another technology capable of achieving this.
Auger Filling Technology
Auger filling technology involves a rotating helical screw, known as an auger, to convey and dispense powder into containers. The controlled speed and rotation of the auger contribute to precise dosing. This technique is versatile, accommodating a wide range of powder characteristics, from free-flowing to non-free-flowing substances. Auger fillers are renowned for their high precision and speed, making them suitable for applications where accurate dosing of large volumes is essential. 3P Pharma’s Micro Auger offers powder filling flexibility with the ability to fill a wide variety of devices including reconstitute injection devices, vials, cartridges, syringes, inhalers and sachets.
Vibratory Filling technique
Vibratory filling utilises vibration to settle and compact the powder, facilitating the filling of a higher volume into containers. This technique is particularly effective for settling powders with low bulk density. Vibratory fillers can achieve high-speed filling due to the efficient settling process, making them ideal for lightweight, fluffy powders. 3P innovation's Vibratory Feeder is a versatile, compact powder filler designed to increase productivity, improve accuracy and enhance operator safety in lab and clinical manufacturing. Its system ensures gentle handling of powders without causing compaction. This is crucial for preserving the integrity and characteristics of delicate or sensitive powders, preventing any undesirable alterations during the filling process.
Contact us to discuss which powder filling technique is best for your manufacturing needs.
As pharmaceutical technologies evolve, so too does our ability to refine and elevate aseptic processes, pushing the boundaries of what is achievable in the pursuit of excellence in drug manufacturing. The choice of powder filling technique hinges on factors such as powder characteristics, required accuracy, production speed, and budget considerations. Auger, vibratory, and gravimetric filling methods each have their strengths and limitations, and selecting the most appropriate one for a given application is crucial for achieving optimal results in powder filling operations. 3P innovation have a number of existing aseptic filling lines in use global for both commercial and clinical filling application, please contact us for further information
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