Pharmaceutical instrumentation encompasses a wide variety of products, equipment, and machinery. Each type of instrumentation plays an important role in each unique step of the manufacturing process. Instrumentation for the pharmaceutical industry requires the highest level of precision, reliability, and quality.
According to a recent report from Research and Markets the total analytical instrumentation market generates almost $18B in sales with the pharmaceutical, biotechnology, and life sciences end-user sector capturing 34.3% of the total market.
The Importance of Raman Spectroscopy
Raman spectroscopy has become an important an important analytical measurement tool in a variety of pharmaceutical applications. Raman spectroscopy is a form of vibrational spectroscopy, much like infrared (IR) spectroscopy. Chemicals, such as drugs, can be identified by the frequency and quantified by the intensity of the peaks.1 It relies on inelastic scattering, or Raman scattering, of monochromatic light, usually from a laser in the visible, near infrared, or near ultraviolet range. The laser light interacts with molecular vibrations, phonons or other excitations in the system, resulting in the energy of the laser photons being shifted up or down. The shift in energy gives information about the vibrational modes in the system. Infrared spectroscopy yields similar, but complementary, information.2
Pharmaceutical Analysis
Pharmaceutical testing and analysis equipment can include anything from a reciprocating cylinder, which is utilized in dissolution studies of extended release products, to solubility testing, which measures the solubility of solid drug compounds in liquid immersions. Utilizing new high-quality testing and analysis equipment can help reduce validation timelines and cut overall costs.
Pharmaceutical Testing
Pharmaceutical testing is a critical step in the development process to demonstrate compliance as regulatory requirements continue to expand and evolve. Pharmaceutical testing can include anything from analytical development and validation, to API analysis, to biological sample testing, to clinical trial management, and more. And every step in the testing process brings its own set of challenges.
Depending on testing needs, when choosing testing equipment one should include not only include regulatory compliance and cost, but analysis time and throughput as well. Utilizing high-quality testing instrumentation will allow for regulatory approval in a shorter period of time; all while reducing overall costs.
Quality Control/Quality Assurance
The term quality control (QC) refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance to more complicated requirements of pharmacopoeial monographs.3
QC covers processes used in product development to verify that all design inputs and specifications are fulfilled. Quality assurance (QA) is the testing/batch sampling analysis that validates final product performance and intended use. When issues arise, experiments uncover root causes for corrective and preventive action.
Manufacturers of medicinal products are required by law to possess marketing authorizations from government regulatory agencies in countries in which their products are marketed and to manufacture their products in compliance with Good Pharmaceutical Manufacturing Practice (GMP) standards. These requirements involve conducting appropriate quality control tests to check that the product conforms to a specification that assures its safety and efficacy.3 Looking ahead the report from Research and Markets identifies several key predictions for the total instrumentation market:
- Process/online/continuous analyzers will be in demand more than the laboratory analytical instruments as these instruments reduce additional analysis and improve user’s productivity.
- Food testing, biopharmaceuticals, life sciences, and clinical markets will see high growth driven by advancement in user’s requirements.
- Multi-vendor and value-added services will be in demand, resulting in increased in revenue for manufacturers and third-party service providers.
- Laser-based analyzers will be in demand as it reduces the operational costs for users.
- The need for automation of analytical processes will drive the demand for advanced analytical instrumentation without sample preparation.
CITATIONS:
1. https://www.americanpharmaceuticalreview.com/Featured-Articles/158839-Pharmaceutical-Applications-of-Raman-Spectroscopy/
2. https://en.wikipedia.org/wiki/Raman_spectroscopy
3. Abdoun, Siham, PhD;National Profitional Officer at WHO (2014) [online] Available at: https://www.slideshare.net/SihamAbdallaha/quality-control-of-pharmaceutical-products-31353025