Particle size distribution, or PSD, according to size, list of values of a relative amount of particles present in a given sample. Since pharmaceutical products are required by the FDA to strive for products free of foreign particles, it is essential to be able to quantify and classify particles to maintain the quality of the product. Particle size can affect not only product performance, but also stability as well as dissolution and absorption rates.
Information about particle type, size distribution, morphology and chemistry is used to identify potential contaminates, as well as minimize the cause of contamination. This information can then be used to develop controls for production in FDA-regulated environments. More manufacturers are now opting for the Quality by Design (QbD) approach to assess the safety of drug products by understanding the entire process and making changes to the process before the final product is completed. When following this approach it becomes necessary to find a monitoring technique that fits the needs of the testing facility and allow changes to the process immediately.
There are various techniques available to count and size particles, each with advantages and disadvantages. ASPEX’s Personal SEM® (PSEM) in conjunction with the Automated Feature Analysis (AFA) software is a solution that counts and sizes particles but also gives the chemistry of the particles. This automated particle analysis tool can then be used to locate the source of the contamination during the process. With the easy and quick reporting changes to the process can be made quickly to save downtime and maximize profit. ASPEX’s PSEM complies with 21 CFR part 11 demands and adheres to requirements of cGMP facilities.
Secondary electron imaging is used to obtain surface information to qualitatively describe the sample using surface defects, porosity and tri-dimensional structure evaluation. Backscatter electron imaging displays compositional contrasts used to find features during the automated analysis, and can be digitally stored or captured on film. The energy dispersive spectrometer (EDS) uses silicon drift detectors (SDD) to provide high throughput particle analysis but providing the chemical composition and relative proportions of the sample.
Particle Size Distribution is a valuable tool for pharmaceutical production, leading to identification and possible elimination of harmful foreign particulates. By utilizing the Personal Scanning Electron Microscope (PSEM) with Automated Feature Analysis (AFA) software, pharmaceutical companies have the most powerful tool on the market to quickly and accurately analyze particles.
Reference:
Foreign Particle Size Distribution and Characterization in Pharmaceutical Products Using a High Throughput Electron Beam Analyzer
http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0015199&ISSUE=0811&RELTYPE=ATO&PRODCODE=6040&PRODLETT=A&CommonCount=0
