The first question most people ask is how much can I mix in the SpeedMixer? To answer this question, we first must discuss two important factors – volume requirements within the mixing jar and total system weight.

First, you must determine the proper jar size for mixing the formulation. Mixing quality depends on proper volume inside the mixing jar. For optimal mixing, we recommend a fill volume of 1/3 - 1/2 of the jar capacity. Of course, there may be some exceptions. For example, when working with Progesterone powder formulations, you can push the upper limit to approximately 80% fill. The powders will compact during mixing to approximately 60% capacity, but mixing quality is not adversely affected.

PCCA carries an assortment of jar sizes, from 60 mL to 1200 mL jars, to get you started. Most jars (except the two largest jars) require a separate holder. The table below outlines the various jars and holders stocked by PCCA; however, additional sizes can be ordered directly from FlackTek if desired.

The next factor to consider when mixing is total system weight, which refers to the combined weight of the: JAR + HOLDER (if required) + FORMULATION. Functional operation relies on proper total system weight, which is between 300 Gm – 600 Gm. As an example, let’s assume you want to mix a 100 Gm batch of Estriol/Estradiol [50%/50%] 1 mg/Gm Topical Gel (VersaBase® Anhydrous HRT). Since the density of this formula is close to 1, you would want to choose the SC250 (mL) jar. This would result in a fill volume of approximately 40%. Next, let’s look at total system weight: SC250 JAR + SC250 HOLDER = 450 Gm, + FORMULATION weight of 100 Gm = 550 Gm COMBINED WEIGHT. Now you have met the two requirements to start mixing!

When utilizing our largest jar (MAX XL – SC 1200 mL), we typically mix no more than 480-490 mL’s (or Gm’s) for most liquid or cream formulations due to the weight of the SC 1200 JAR, which is approximately 110 Gm (to not exceed the 600 Gm combined weight limit). For mixing 500 mL (or Gm) formulas in the MAX XL cup (assuming volume is within the proper range in the jar), a FlackTek representative can work with you to adjust the setting to allow for the additional 10 Gm weight. Please note that pushing the weight limitations on this machine any further than this can result in balance issues, which over time can reduce the life of the machine.

For powder mixing, the maximum amount that can be mixed successfully greatly differs from one API/excipient to the next due to the density of the powder and the volume it occupies in the jar. To put this into perspective, approximately 320 Gm’s of Lactose Monohydrate will occupy 50% of the SC1200 mL jar, compared to only 90 Gm’s of Progesterone USP Special Micronized or 209 Gm’s of Microcrystalline Cellulose NF.

PCCA has tested over 40 formulations in the SpeedMixer using a variety of PCCA Bases. All formulas in the database have been validated through chemical potency testing of multiple points within the formula to ensure potency and uniformity. It is important to note that any deviation from the listed procedure, container or batch size would require re-validation of that process to ensure potency/uniformity is met.

The FlackTek SpeedMixer is known for its world-class quality. It is hand built in the United States to the highest standards, producing an exceptionally robust machine that stands up to frequent and heavy use. In addition, FlackTek customer service is unmatched in their industry. If you are looking to optimize efficiency by reducing cleanup and mixing time of many popular formulas, look no further than the FlackTek SpeedMixer DAC 1200-500.