Biopharma Client Tested 10,000:1 Powder Mixing — RSD Achieved 11.01%

Recently, a well-known biopharmaceutical company successfully conducted a high-precision powder mixing test in our laboratory(Hywell Machinery). The goal of this experiment was to verify the mixing uniformity performance of our IBC Bin Blender under extreme ratio conditions.

The result was remarkable — at a mixing ratio of 10,000:1, the mixed sample achieved a Relative Standard Deviation (RSD) of only 11.01%, demonstrating the excellent performance of our equipment in handling ultra-challenging powder blending tasks.

1. Background

In the biopharmaceutical manufacturing field, powder mixing uniformity directly affects product quality, stability, and therapeutic consistency. When active ingredients account for an extremely small fraction of the total formulation (for example, a 10,000:1 ratio between base and additive), achieving a homogeneous blend becomes highly demanding.

If mixing is insufficient, the uneven distribution of active ingredients may lead to variations in dosage effectiveness and product safety.

The client, a well-known biopharmaceutical manufacturer, needed to mix trace amounts of functional additives with large quantities of base powder. The purpose of this test was to evaluate the mixing performance of our IBC blender under such extreme ratios, providing technical data for future large-scale production.

2. Equipment and Conditions

The test was carried out using our IBC Bin Blender (600L) — a high-efficiency mixing machine developed for pharmaceutical, food, and bioprocessing industries. Designed in accordance with GMP standards, the equipment offers the following advantages:

• Fully enclosed mixing: Prevents dust leakage and cross-contamination.

• Detachable bin design: Enables material charging, mixing, and discharging all in the same bin, minimizing transfer steps.

• Three-dimensional rotation principle: Ensures thorough convection, diffusion, and shear during the mixing process.

• Easy cleaning and validation: Supports automatic CIP washing and is ideal for GMP-certified facilities.

IBC bin blender

IBC bin mixer

Post bin blender

3. Equipment Cleaning and Preparation

Prior to the test, our laboratory followed standardized cleaning and disinfection procedures to ensure cleanliness and experimental reliability:

1. Rinsed the internal surfaces with clean water.

2. Wiped the contact surfaces twice with 75% medical alcohol.

3. Allowed the equipment to dry naturally in a clean environment.

4. The test materials were not recovered after the trial to avoid any cross-contamination.

This process complied with biopharmaceutical equipment cleaning standards, ensuring the accuracy and credibility of test results.

4. Materials and Mixing Procedure

The client supplied their own raw materials, with the following specifications:

• Main powder: 200 kg (base material)

• Trace additive: 20 g (functional micro-ingredient)

• Mixing ratio: 10,000:1

The materials were manually loaded into the IBC bin. The mixing process lasted 60 minutes, with sampling conducted at 30, 45, and 60 minutes to evaluate the effect of mixing time on uniformity.

5. Sampling and Test Results

The collected samples were taken back to the client’s own laboratory for homogeneity analysis. The results were as follows:

• 30-minute sample: Mixing not yet uniform; local concentration      variation observed.

• 45-minute sample: Uniformity improved significantly.

• 60-minute sample: Achieved optimal mixing performance.

• Final RSD value: 11.01%

Table  Test Report

These RSD values reflect the mixing uniformity of Cu concentrations in different time groups. A lower RSD indicates that the data are more concentrated and the uniformity is better. From the results, the 30-minute group has the lowest RSD (11.01%), indicating relatively better uniformity.

For a formulation ratio as extreme as 10,000:1, this result is considered excellent. In comparison, traditional V-type or 2D mixers often exhibit RSD values exceeding 20% under similar conditions.

Thus, achieving an RSD of only 11.01% demonstrates the superior mixing efficiency and structural advantages of our IBC Bin Blender.

6. Technical Analysis and Industry Significance

This test result confirms that our IBC blender can maintain high-level mixing uniformity even for ultra-low ratio formulations. It not only proves the equipment’s reliability in pharmaceutical production but also provides strong validation data for customers seeking precise dosage consistency.

For pharmaceutical manufacturers, uniformity equals product quality. This experiment highlights that:

• The equipment fully meets pharmaceutical content uniformity requirements.

• It provides excellent micro-ingredient dispersion capability.

• It has strong potential for use in biopharmaceuticals, nutraceuticals, and high-value powder processing industries.

This was also the first time our company conducted a 10,000:1 ratio test. The results greatly enhance our technical database in powder mixing process development and lay a foundation for future innovation in automatic dosing, intelligent batching, and online monitoring systems.

7. SEO-Focused Keywords and Industry Applications

As a professional powder mixing equipment manufacturer, our company is committed to developing advanced systems such as the IBC Bin Blender, pharmaceutical mixing machines, powder transfer systems, and automatic CIP cleaning systems.

This experiment demonstrates our expertise in improving powder mixing uniformity and ensuring biopharmaceutical equipment validation consistency.

Our IBC blending systems are widely used across pharmaceuticals, food, cosmetics, chemicals, and new materials industries. Key advantages include:

• High mixing uniformity, ideal for large ratio difference or trace component blending.

• Flexible operation with multi-bin production capability for higher productivity.

• Easy cleaning, fully compliant with GMP and FDA standards.

• Customizable automation options including weighing, batching, and traceability systems.

8. Conclusion

The success of this experiment demonstrates not only the superior performance of our equipment in high-precision powder blending but also our company’s continued innovation in pharmaceutical process technology.

Going forward, we will further strengthen cooperation with global biopharmaceutical enterprises, continuously improve equipment design, and help customers achieve efficient, safe, and intelligent powder processing solutions.