Size Separation in Pharmaceutics
1. Introduction and Objectives of Size Separation
Size separation, also known as sieving or screening, is a crucial operation in pharmaceutical
processing for the classification of particulate materials according to size. The objective of size
separation is to ensure uniform particle size distribution for effective formulation, improved flow
properties, enhanced dissolution, and consistent therapeutic action of drugs. It plays an essential
role in granulation, tablet formation, powder blending, and coating processes.
**Objectives:** - To obtain particles of uniform size for better mixing and uniform dosage. - To
improve the efficiency of subsequent processing steps like drying and coating. - To control particle
size for optimizing dissolution rate and bioavailability. - To eliminate oversized or undersized
particles to achieve the desired pharmaceutical quality.
2. Applications of Size Separation
Size separation finds wide application in the pharmaceutical, chemical, and food industries. In the
pharmaceutical industry, it is employed to classify powders, separate granules, and remove
impurities. During tablet manufacturing, it ensures uniform particle size, which directly affects tablet
hardness, disintegration, and dissolution rate. In powder filling operations, size separation ensures
free flow of powders, avoiding segregation and ensuring dose uniformity.
3. Mechanism of Size Separation
The basic principle involves the movement of particles through sieves or air streams based on their
size, shape, and density. Particles smaller than the sieve aperture pass through, while larger ones
are retained. In air separation, particles are classified using air velocity — lighter particles are
carried away, while heavier ones settle due to gravity. The efficiency of separation depends on
particle uniformity, moisture content, sieve mesh size, and vibration frequency.
4. Official Standards of Powders (IP)
According to the Indian Pharmacopoeia (IP), powders are classified based on the proportion of
particles passing through standard sieves of specified apertures: - **Coarse Powder:** 100%
passes through sieve no. 10; not more than 40% through sieve no. 44. - **Moderately Coarse
Powder:** 100% passes through sieve no. 22; not less than 40% through sieve no. 44. -
**Moderately Fine Powder:** 100% passes through sieve no. 44; not less than 40% through sieve
no. 85. - **Fine Powder:** 100% passes through sieve no. 85. - **Very Fine Powder:** 100%
passes through sieve no. 120. These standards ensure uniformity, reproducibility, and predictable
behavior in formulations.
5. Sieves: Construction and Use
Sieves consist of a woven wire cloth of specific mesh number fixed in a brass or stainless-steel
frame. Mesh number indicates the number of openings per linear inch. The sieve series commonly
used are 10, 22, 44, 60, 85, 120, and 240. Sieves are used in sets, forming a sieve stack, with the
coarsest on top and the finest at the bottom. The powder is placed at the top and subjected to
shaking or vibration to classify particles.
6. Principles of Size Separation
The principle of size separation is based on the movement of particles through a sieve or an air
stream depending on their size, shape, and density. The driving forces include gravity, centrifugal
force, or airflow. Key principles include: - Differential motion: smaller particles move faster and pass
through sieves. - Air classification: lighter particles are carried away by airflow. - Centrifugal
classification: heavier particles move outward, and lighter ones remain near the center.
7. Sieve Shaker: Construction, Working, Uses, Merits & Demerits
**Construction:** A sieve shaker consists of a motor-driven mechanism that imparts both horizontal
and vertical vibrations to a stack of sieves. **Working:** The powder sample is placed in the top
sieve, and vibration causes particles to move and segregate according to size. **Uses:** Employed
for particle size analysis and powder classification. **Merits:** Accurate, simple, and economical.
**Demerits:** Time-consuming and not suitable for very fine powders due to clogging.
8. Cyclone Separator: Construction, Working, Uses, Merits &
Demerits
**Construction:** It consists of a cylindrical body with a conical base, an air inlet tangentially at the
top, and an outlet for fine particles at the top center. **Working:** The air containing particles enters
tangentially, creating a vortex. Centrifugal force pushes heavier particles to the wall, which slide
down and are collected, while lighter particles exit through the top. **Uses:** Widely used for
separating dust from air, recovering powdered products. **Merits:** No moving parts, low
maintenance, efficient for coarse particles. **Demerits:** Inefficient for very fine particles (<5 µm).
9. Air Separator: Construction, Working, Uses, Merits & Demerits
**Construction:** Consists of a chamber through which air passes at controlled velocity, with
particle feed from one end and an outlet for separated fractions. **Working:** Based on
aerodynamic classification, where particles are separated according to weight and size. Lighter
particles are carried away by air, while heavier ones settle due to gravity. **Uses:** Used for
separation of fine powders and dust removal. **Merits:** Continuous operation, suitable for fine
powders. **Demerits:** Requires precise air velocity control and maintenance.
10. Conclusion
Size separation is an indispensable step in pharmaceutical manufacturing to ensure uniformity and
quality of drug products. Techniques like sieving, air classification, and cyclone separation are
essential tools that provide control over particle size distribution. Proper understanding of principles,
standards, and equipment ensures optimized processing and product performance.