Within the wet granulation process, the initial steps of screening, delumping, and milling help to prepare materials for further processing downstream. These processes are integral to creating tablets and capsules that meet stringent quality standards.
Achieving Target Particle Size Distribution for Optimal Results
Achieving the target particle size distribution (PSD) is a primary goal to ensure that your powders are free-flowing and suitable for future stages of the wet granulation process. The form of the powdered materials influences the flowability, compressibility, and homogeneity of the material being processed. Not reaching the desired PSD at this early stage will increase the risk of mix segregation and reduce the uniformity of the final product.
To achieve the desired PSD, manufacturers must make sure they select the correct equipment and process parameters.
The Role of Screening, Delumping, & Milling in Wet Granulation
The initial step in wet granulation involves screening, delumping, or milling to prepare the powdered ingredients for granulation. When powders arrive at the manufacturing facility, they often contain agglomerated lumps that can impede the flow and consistency of the material. Therefore, the first step involves breaking down these lumps to achieve a more uniform particle size distribution (PSD). The choice of method depends on the state of the powder.
Ideal Conditions for Wet Granulation
Blend Homogeneity
One of the primary goals of the initial wet granulation step is to enhance blend homogeneity. Achieving a uniform blend is crucial for ensuring that each dosage form contains the correct amount of active ingredients.
The screening, delumping, and milling processes ensure that APIs and excipients are evenly distributed throughout the blend. This uniformity reduces the risk of segregation during subsequent processing steps, enhancing the quality and consistency of the final product. Moreover, a well-homogenized blend ensures that tablets and capsules have uniform weight and content, which is critical for meeting regulatory standards.
Smooth Powder Flow
Improving powder flow is another key objective of this step. By refining the PSD and removing lumps, manufacturers can enhance the flow properties of the powder, ensuring smooth and consistent movement through the processing equipment.
High Production Output & Product Recovery
As with all manufacturing processes designed to meet demand, choosing the correct mill screen is essential. Ensuring that you have the appropriate size reduction equipment for the initial step of wet granulation will prevent potential blockages from occurring further down the production line. Your powder ingredients will also be processed properly in order to meet the required PSD, reduce heat generation, and ultimately increase your throughput.
Reduced Cleaning
Product buildup on screens and impellers increases the frequency of machine downtime. Quadro's patented "High Efficiency" conical screens minimize the need for cleaning, thanks to reduced heat generated during the milling process. This not only saves time when cleaning, but also reduces material waste.
Equipment for Milling, Screening & Delumping Pharmaceutical Powders
The Quadro® FlexSift and Quadro® Comil® offer a comprehensive solution for screening, delumping, and milling as an initial step in wet granulation. Their advanced design makes them essential tools in pharmaceutical manufacturing with unparalleled efficiency and precision.
The Quadro® FlexSift
The Quadro® FlexSift offers enhanced security screening and deagglomeration, ensuring that any unwanted particles or contaminants are efficiently removed from the powder. Its high product recovery rates mean that virtually all the material is processed, minimizing wastage and maximizing output.
The centrifugal acceleration within the sifting chamber ensures a continuous flow of particles through the mesh. This ensures that only the desired particles are allowed through, whilst any impurities are retained for later removal. The ideal mesh size is carefully selected through consultation between the experts at Quadro and the customer in order to meet their precise process specifications.
The Quadro® FlexSift is meticulously engineered to comply with stringent FDA cGMP standards. These standards are critical for maintaining the integrity and purity of pharmaceutical products. Quadro's commitment to adhering to these guidelines reflects its dedication to offering a robust solution that aligns with industry regulations, thereby fostering trust and reliability in pharmaceutical manufacturing processes.
The Quadro® Comil®
Renowned for its versatile milling capabilities, the Quadro® Comil® has been the industry standard for almost half a century. It is used in the wet granulation process for sizing, delumping, and deagglomerating, as well as reclaiming.
With a wide array of screen and impeller options, it provides manufacturers with the flexibility to achieve their desired PSD while maintaining low energy consumption. This versatility ensures that the Comil® can handle a variety of materials, from delicate APIs to tougher excipients, without compromising on quality.
It is also designed to reduce material build-up, minimize cleaning needs, equipment downtime, and cut labor costs.
The Quadro® Comil® is engineered for high throughput, allowing manufacturers to process large volumes of material quickly and efficiently. Its low-energy milling capabilities ensure that the process is not only efficient but also cost-effective, reducing energy consumption and operational costs. Together, these machines provide manufacturers with the tools they need to maximize production output and product recovery, enhancing productivity and profitability.
Why Quadro is the Preferred Choice for Manufacturers
Throughout a span of over 40 years, Quadro mills have become the top choice for pharmaceutical manufacturers due to their advanced design and high throughput capabilities, making them essential for wet granulation.
Our mills offer manufacturers a comprehensive solution for the milling, screening, and delumping steps of wet granulation. Their advanced design, versatility, and efficiency makes them the preferred choice for achieving optimal results in the pharmaceutical oral solid dosage manufacturing process.
