Hello good people of the world! Today’s post is the first in a series covering considerations around the commissioning, qualification, and validation of facilities, systems, and equipment involved in the manufacture of oral solid dose (OSD) products. OSD is a wide-spread method of pharmaceutical delivery, including well known medicines such as aspirin, Viagra, and many antibiotics. Solid doses can take the form of powders, tablets, capsules, pills, lozenges, granules and more.
Here we’re going to cover the physical and chemical properties that should be considered in equipment design.
First, environmental factors:
- Temperature and Humidity: temperature and humidity should be controlled even if the product is not sensitive, as most processes are susceptible to flow issues in the extreme temperature and/or humidity ranges.
- Light: some OSD products are light (especially UV light) sensitive and must be protected from sunlight and even indoor light in some cases.
- Oxygen: some products may also be sensitive to oxygen exposure.
Second, process factors:
- Particle size and size distribution: powders inevitably have some variation in particle size that must be understood and controlled
- Particle shape: similarly to size, particles will have variation in shape
- Surface properties: are the particles smooth or rough? Do they stick together? Do they readily absorb moisture? Surface properties must be understood
- Particle strength: particles will break down under enough force. Particle strength must be understood and undue stress avoided in manufacturing processes.
- Density, porosity, and packing: how does a particle pack? Things like minimum bulk density, poured bulk density, and tapped bulk density should be understood.
- Cohesion in powders: related to surface properties, how to particles stick together? Magnetic, electrostatic, and intermolecular forces may be in play and should be understood.
What factors do you consider in your OSD manufacturing process?
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