Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems - Pharmaceutical Technology

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Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems
The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.


Pharmaceutical Technology
Volume 33, Issue 1, pp. 72-80


Table I: Major functions and devices of blister-filling and packaging systems.
Functions and devices of blister-filling and packaging systems. Blister-filling and packaging systems consist of 11 major functions and 15 major devices as listed in Table I. The forming function, the sealing function, and the speed-control function directly affect web film thickness and seal quality. The speed-control function controls the duration of the heating and pressing processes.


Figure 2: The direct factors of the forming, sealing, and speed-control functions. (All figures are courtesy of the authors and the Japan Society of Pharmaceutical Machinery and Engineering.)
A fishbone diagram of the direct factors of blister-filling and packaging systems. Figure 2 is a fishbone diagram of the direct factors of the forming, sealing, and speed-control functions. The important devices for fulfilling the forming, sealing, and speed-control functions are the heating device, the forming device, the sealing device, and the speed-control device. The following parts of those devices affect the web thickness or the sealing quality: the heating plate of the heating device; the forming die, the forming blower, and the plug of the forming device; and the sealing die and the die roll of the sealing device (see Table II).


Table II: Classification of direct factors of blister-filling and packing systems.
For example, the required function of the heating plate is to uniformly transmit a prescribed quantity of heat to the plastic film.

According to the above principles, the temperature, temperature distribution, surface accuracy, and parallelism between the upper and the lower heating plates are direct factors. The same principles apply to the other three devices (see Figure 2).

The other devices in blister-filling and packaging systems do not include direct factors. Table II shows a classification of the direct factors in Figure 2 based on the discussion above.

Direct factors of blister-filling and packaging systems and qualification


Table III: Qualification stages of direct factors of blister-filling and packing systems.
Required qualification stages of direct factors. Table III shows the required qualification stages for each class of direct factors in Table II.

Stages from DQ to performance qualification (PQ) are required for dynamic factors in Class 1-A, which are subject to the process control prescribed in the product master formula. Stages from DQ to OQ are required for dynamic factors in Class 1-B, which are not subject to process control. However, PQ also may be required for Class 1-B factors when the run speed is the only factor to be changed. Usually run speed is constant, but when this speed must be changed for some reason, the modified speed could be controlled in the process, as represented by the dotted arrow in Table III. Static factors require DQ and installation qualification (IQ).


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