Achieve Minimum Divergence in Fill
Counts for Solid Oral Dosage Forms
It is not difficult to for solid oral dosage forms using high-quality equipment. Solid oral dosage
forms include achieve minimum divergence in fill counts capsules, tablets, caplets, or gel caps,
or soft/liquid gels. Fill sensors and in-line check systems are part of effective equipment that
reduces variance. In addition, conducting statistical evaluations of processing sets a realistic
practically achievable fill-count target
One of the challenges in this area is that the US Food and Drug Administration (FDA) have not
specified guidelines for achieving minimum divergence in fill counts. Nevertheless industry
expert Troy Fugate, vice president at Compliance Insight, Inc. has developed recommendations
based on the Code of Federal Regulations. Pharmaceutical manufacturers seeking effective
solutions should consider these suggestions for solid dosage form processes:
Choose the best equipment. It must be designed for accurate output and also for
To ensure long term results, manufactures must create a maintenance schedule that
calibrates the equipment on a regular basis for desired performance.
Do not accept any compromise on the equipment specifications.
To be clear, 100 percent accuracy in fill-count targets for oral dosage forms is not possible in
practical terms. But stringent monitoring of the process and equipment leads to keeping
variance to an absolute minimum.
The type of solid dosage form utilized will impact the variance in fill count. Certain factors
dependent on mechanical aspects of the process may be controlled. But variables like static
charge, dust etc. are difficult to control. To be successful, concentrate on factors that can be
monitored and maintained.
The following items outline the requirements of regular maintenance to control variance:
Appropriately evaluating equipment and processes regularly.
Directing maintenance staff to perform regular calibration and preventive maintenance
Choose high-quality equipment that meets or exceeds industry standards.
Daily review all processing.
In conclusion, it is important to set clear targets from the beginning. Do not set accuracy targets
of less than 100 percent because you believe that variance is not avoidable. The problem is that
this thinking actually leads to worse results. Aim for 100 percent accuracy. This will help you put
the strict monitoring in place to achieve the best possible fill counts. Pharmaceutical
manufacturers using the best equipment over the past twenty years has demonstrated that 100
percent fill counts is possible.
Author: Beth James
Pharmaceutical compliance resource website: http://compliance-insight1.com/
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