**3.1 Quality control of the tableting/encapsulating process**

The dried amoxicillin produced according to **Figure 9** will now be mass produced into tablets and capsules using automated tableting (**Figure 10**). Tablets are normally manufactured by direct compression or by granulation depending on material properties and the relevant requirements for formulation. During tablet manufacture the powder is fed to the machine and blended before tableting unit

**145**

**Figure 9.**

**Figure 10.**

*Quality Control Perspectives during Mass Production with a Focus on the Chemical Industry*

operations kick off. The mass production process would also need to be monitored

The tablet press is a multi-stage process split up into stations with each station going through the routine of die filling, metering, pre-compression, maincompression, tablet ejection and take-off from lower punch, as shown in **Figure 10**. After the blend is fed into the die, the metering stage is adjusted to achieve the dosing position, i.e. the volume of powder inside the die. The powder is then locked between upper and lower punches during pre-compression and main-compression until the tablet ejection and take-off stages are reached. The pre-compression stage serves to remove air trapped in the die and to rearrange the particle packing, while the main compression stage compacts and transforms the powder bed into a tablet. The tablet weight can be controlled by changing the dosing position subject to variations in powder bulk density, and in filling time due to changes in turret speed, or in filling efficacy due to changes in powder flow properties. The in-die tablet thickness is determined by the punch displacement which is manually set before the tableting operation for the tablet press used in this study. Hence, the maximum

for consistency by strict quality control procedures.

*Tablet weight measurement real-time monitoring and control [17].*

*DOI: http://dx.doi.org/10.5772/intechopen.90203*

*Process flow diagram for the manufacture of amoxicillin [20].*

*Quality Control Perspectives during Mass Production with a Focus on the Chemical Industry DOI: http://dx.doi.org/10.5772/intechopen.90203*

#### **Figure 9.**

*Mass Production Processes*

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**Figure 7.**

**Figure 6.**

*Amoxicillin capsules and tablets.*

**Figure 8.**

*Structural formula of amoxicillin (6-aminopenicillanic acid).*

*GSK manufacturing Plant at Irvine (GSK Website).*

**3.1 Quality control of the tableting/encapsulating process**

The dried amoxicillin produced according to **Figure 9** will now be mass produced into tablets and capsules using automated tableting (**Figure 10**). Tablets are normally manufactured by direct compression or by granulation depending on material properties and the relevant requirements for formulation. During tablet manufacture the powder is fed to the machine and blended before tableting unit

*Process flow diagram for the manufacture of amoxicillin [20].*

#### **Figure 10.**

*Tablet weight measurement real-time monitoring and control [17].*

operations kick off. The mass production process would also need to be monitored for consistency by strict quality control procedures.

The tablet press is a multi-stage process split up into stations with each station going through the routine of die filling, metering, pre-compression, maincompression, tablet ejection and take-off from lower punch, as shown in **Figure 10**. After the blend is fed into the die, the metering stage is adjusted to achieve the dosing position, i.e. the volume of powder inside the die. The powder is then locked between upper and lower punches during pre-compression and main-compression until the tablet ejection and take-off stages are reached. The pre-compression stage serves to remove air trapped in the die and to rearrange the particle packing, while the main compression stage compacts and transforms the powder bed into a tablet. The tablet weight can be controlled by changing the dosing position subject to variations in powder bulk density, and in filling time due to changes in turret speed, or in filling efficacy due to changes in powder flow properties. The in-die tablet thickness is determined by the punch displacement which is manually set before the tableting operation for the tablet press used in this study. Hence, the maximum

main-compression force depends on the amount of powder in the die or, equivalently, on the tablet weight.
