Oral Solid Dose – Supporting Equipment and Systems

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about supporting equipment and systems. The main equipment in unit operations get the spotlight when it comes to manufacturing Oral Solid Dosage forms, but they cannot work without supporting equipment and systems.

Supporting Equipment:
Typical supporting equipment in a OSD manufacturing process includes:

1. Air Systems: all modern manufacturing processes use air systems for process, instruments, and environment. HVAC helps control environmental conditions, including particulate (viable and nonviable) counts, temperature, and humidity. Compressed air systems may be used in the process to cool or cover product, such as with nitrogen, or operate unit operation steps, such as in fluid bed drying. Automated systems will use compressed air to pneumatically control valves and other components.
2. Dust Collection: compared to biotech and other pharmacuetical processes, OSD processes have the added complication of dust collection. OSD material movement and processes can create a lot of dust, which can be a risk from a product quality point-of-view, but also a safety point-of-view, since dust can lead to fires and even explosions. Dust collection equipment must be employed to minimize and control dust.
3. Vacuum Systems: vacuum systems may be used for cleaning, dust collection, and also in process steps such as vacuum drying.

Supporting Systems:
Typical supporting systems include:

1. Change Control: it is expected that engineering changes are controlled with quality oversight through a formal process.
2. Preventive Maintenance: it is expected that regular preventive maintenance be performed and documented formally.
3. Calibration: it is expected that “critical” instruments are calibrated at regular intervals traceable to an international standard. Calibration procedures and results must be formally documented. The method to determine and results of the determination of critical instruments must be documented.

What supporting equipment and/or systems do you use in your OSD manufacturing process? Comment below!

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Oral Solid Dose – Unit Operations

Granulator at an OSD Plant in Vietnam

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about unit operations typical in a oral solid dose manufacturing process.

Typical OSD processes may include some combination of weighing/dispensing, material transfer, blending, granulation, drying, milling/sieving, compression, encapsulation, and coating. Some considerations around each step may include:

1. Weighing/Dispensing: includes sampling for quality purposes. Materials to be sampled typically include: APIs, excipients, primary and secondary packaging, cleaning agents. Sampling areas must be protected from contamination.
2. Material Transfer: material flows should be documented and reviewed, with the intention of minimizing any contamination.
3. Blending: materials are typically blended to ensure a uniform composition, prior to downstream process steps. Many methods exist, including: tumble blending, bin blending, and agitator mixers.
4. Granulation: granulation is the process of combining particles into a granule. Many methods of granulation exist: wet massing/extrusion, high shear, spray, speronization, and hot melt extrusion, for example.
5. Drying: the purpose of the drying step is to remove any excess moisture from the drug product. Drying methods include: tray , fluidized bed, and spray drying.
6. Milling/Sieving: the purpose of this process step is to reduce granule size to conform to specification. Some methods include: impact/hammer mills, conical mills, and oscillating horizontal screens.
7. Compression: compression is used to create tablets.
8. Encapsulation: encapsulation is used to create capsules.
9. Coating: coating is used to apply a coat to tablets

In the next post we’ll cover supporting equipment and quality systems. What process steps do you use in your OSD process? Comment below!

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