Are bodies are remarkably complex organic machines capable of achieving amazing feats. By the same token however, this complexity has the potential to spell disaster from even the most minute changes: a sustained injury, a chemical imbalance, and other seemingly-minor factors can all contribute to a change in state that may threaten the health and wellness of the individual. Doctors must work side by side with pharmaceutical companies to identify and treat the underlying causes of one’s ailment or irregular chemical balance, but how do the pharmaceutical companies know that their drug will work? Aside from rigorous testing and government approval, drug companies need to rely on an unparalleled level of precision in order to protect consumers and ensure that their product will operate as intended.
How the FDA Enforces Drug Guidelines
With literal lives on the line, pharmaceutical companies have faced tremendous pressure in light of rising drug costs, corporate scandals, and other issues that make the American people less than trustful of these drug companies. In order to ensure safe, quality products the analytical method validation guidelines put in place by the American Food and Drug Administration (FDA) are meant to protect consumers while allowing the pharmaceutical company to reproduce the necessary conditions to obtain results within the proposed acceptance criteria. These analytical method validation guidelines must be pre-approved by the FDA and include particle size specification. For some drugs, the particle size of the drug substance is critical to drug product performance; this is true for powders, suspensions, emulsions, and aerosols — thus the FDA’s analytical method validation guidelines require that companies have access to precise particle size determination methods to keep consumers safe and ensure the product operates as intended.
The Old Method of Quality Control: Sieving
The use of a sieve is one of the oldest methods for particle sizing and is essential to the pharmaceutical industry by ensuring that oversized contaminates are removed from finished products. Particle size analysis through sieving starts with a sampling taken from bulk powders — quality control testing is done multiple times throughout the day on different batches. The bulk sample is then strained in different batches to ensure uniformity before being dispersed. After the sample passes through the sieve, measurements are taken and compared to previous data samplings before a report is issued to pharmaceutical staff. Although modern pharmaceutical sieves have grown in size and changed shape, they remain functionally the same from those used centuries prior. Since sieves are typically used for relatively large particles over 1 mm in size, many pharmaceutical companies have instead opted for a more modern approach to particle size testing.
Modern Laser Diffraction for Particle Analysis
Over the past 20 years, many pharmaceutical companies have replaced traditional methods such as sieving with laser diffraction instead. Laser diffraction has the ability to measure particles that are even smaller than .5mm using a laser diffraction particle size analyzer; standard equipment is capable of measuring particles as small as 400 nanometers yet newer equipment is capable of measuring particles even smaller! Laser diffraction works when a beam of light becomes scattered by small groups of particles; the angle of light scattering is inversely proportional to the relative size of the particle itself so the smaller the particle the larger the angle of light being scattered. The advanced precision of standard laser diffraction for pharmaceutical applications give drug manufacturers the tools they need to stay within the FDA’s analytical method validation guidelines. To ensure the continued quality and safety of their products, many pharmaceutical companies choose an analytical testing laboratory equipped with laser diffraction testing equipment. Many experts in the field believe that within the next decade sieving will be all but replaced by laser diffraction as the default method for particle analysis. As pharmaceutical companies continue to innovate and cure the world, rest assured knowing that every move they make is regulated by the standards and practices set forth by the FDA’s analytical method validation guidelines thanks to the advanced equipment needed for said validation.
