Raman microscopic applications in the biopharmaceutical industry: in situ identification of foreign particulates inside glass containers with aqueous formulated solutions.
Particle identification is an important analytical procedure for quality control and assurance in the biopharmaceutical industry. Rapid and reliable identification of micro-particles helps in evaluating the nature of particle contamination and its consequences on the product quality regulated by internal and external standards. Raman microscopy is one of the microspectroscopic techniques that can be used to identify micro-particles with the advantage of in situ detection. In this paper we demonstrate that a visible laser Raman microscope was particularly useful to identify micro-particles that were inside glass containers such as glass syringes, vials, and test tubes, which are commonly used as containers for aqueous formulated drugs. The examples include the identifications of a droplet-like particle inside a pre-filled glass syringe, a fibrous particle inside a glass test tube, and a white particle inside a glass vial; all of these examples usually demand challenging or time-consuming sample manipulation for other techniques. The Raman microscopic technique was shown to be able to solve these challenging micro-particle identifications due to its ability to carry out detection in situ. Particularly in the example of micro-droplet identification, the Raman microscopic technique was the only choice for a fast and successful particle detection. For all three identifications, Raman in situ detection has significantly accelerated particle analysis and avoided potential sample secondary contamination or losses owing to none or minimal sample manipulation.
Cao
Xiaolin
X
Department of Formulation & Analytical Resources, Amgen Inc., Thousand Oaks, California 91320, USA. xiaolinc@amgen.com
Wen
Zai-Qing
ZQ
Vance
Aylin
A
Torraca
Gianpiero
G
D002482:Cellulose / Q000737:chemistry; D004340:Drug Contamination; D004345:Drug Industry / Q000592:standards*; D005898:Glass; D008853:Microscopy / Q000379:methods*; D019999:Pharmaceutical Solutions / Q000032:analysis* / Q000592:standards; D011126:Polypropylenes / Q000737:chemistry; D013059:Spectrum Analysis, Raman / Q000379:methods*; D013594:Syringes
D019999:Pharmaceutical Solutions; D011126:Polypropylenes; D002482:Cellulose