Pharmaceutical raw material identification is a critical step in quality assurance that has tremendous impact on customer safety and speed and cost of production. The Thermo Scientific microPHAZIR RX Analyzer is a handheld Near-Infrared (NIR) instrument designed for rapid on-site pharmaceutical material identification and analysis. Here are the most frequently asked questions and answers about NIR spectroscopy and how it is used in pharmaceutical and drug manufacturing.
A: Near-Infrared (NIR), a spectroscopic method that uses the near-infrared region of the electromagnetic spectrum, is based on overtones and combinations of bond vibrations in molecules. In NIR spectroscopy, the unknown substance is illuminated with a broad-spectrum (many wavelengths or frequencies) of near infrared light, which can be absorbed, transmitted, reflected or scattered by the sample of interest. Light is absorbed in varying amount by the sample at particular frequencies corresponding to the combinations and overtones of vibrational frequencies of some bonds of the molecules in the sample. The NIR instrument analyzes the spectra and provides rapid, multi-component analysis. Although NIR spectroscopy is not as chemically specific as Raman or FTIR, it can be very useful in probing bulk material with little or no sample preparation.
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A: Traditional laboratory material verification workflows require moving materials into a sampling room, opening and sampling them, documenting samples for tracking purposes, sending samples to the lab, and moving materials into quarantine while awaiting lab results. With handheld NIR spectroscopy, pharmaceutical and dietary supplement manufacturers can verify the identity of incoming materials in the warehouse in minutes and avoid the time and costs of lab testing. Supplied materials such as API, bulking agents, lubricants, and solvents must be qualified at the point of entry into the factory to ensure finished product integrity. Portable NIR analyzers take NIR spectroscopy out of the lab and into the plant. Handheld NIR instruments allow non-expert users to obtain reliable material identity verification in the warehouse.
A: With increasing consumer concerns about the quality, strength and label claims of active ingredients in dietary supplements, the FDA has implemented tighter controls on manufacturing practices. As a result, global nutraceutical manufacturers are seeking technology that will allow them to perform accurate incoming raw material inspection to ensure the quality and strength of finished products.
The latest analyzers based on Near-Infrared (NIR) spectrometry are well suited to identify amino acid, most vitamins, and many other raw materials commonly used in dietary supplement manufacturing.
A: Handheld NIR verification improves supply chain risk management by enabling pharmaceutical manufacturers to meet global GMP requirements, improve inventory management and reduce raw material supply risks. Applications Include:
- Incoming raw material identification
- Quality control and assurance
- Counterfeit product screening
- At-Line Process Analytical Technology (PAT)
- Process troubleshooting
- Quantitative analysis
With NIR spectroscopy, the manufacturer can achieve rapid, multi-component analysis without chemical or disposable costs, determine the quality of incoming raw materials at intake, and monitor and control processes, which help to maximize production and increase profitability.
A: The latest NIR spectrometers for the pharmaceutical industry are designed to meet the stringent requirements of current good manufacturing practices (cGMP) and supports 21 CFR Part 11 compliant processes. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMP provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. According to the FDA,
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
A: Pharmaceutical packaging is carefully designed to provide protection for drug tablets, pills, capsules, and other dosage forms. In addition to providing protection against physical damage, chemical alteration through natural degradation, and environmental contamination, packaging plays an important role in offering evidence of temperature control in the supply chain and product sterility. According to the Code of Federal Regulations (CFR) for pharmaceutical product packaging, components used to temporarily or permanently store drug products such as blisters, films, plastic containers, or vials, must be identified before use by Quality Control (see 21 CFR Part 211.84). This is similar to how raw materials are used in the composition of the drug product.
The latest NIR analyzers can properly identify the most common polymers that are used for the production of finished product packaging in the pharmaceutical and nutraceutical industries. They can measure directly through plastic drum liners and glass containers.
A: The majority of the top twenty pharmaceutical manufacturers use handheld NIR analyzers to verify the identity of either raw materials or finished products. Regulatory agencies in North America, Europe, Asia, and Africa have purchased the analyzers to bolster their anti-counterfeiting efforts. In some countries, regulatory authorities have successfully deployed significant numbers of the instruments to conduct random field screening from the ports of entry to the point of sale. These have facilitated the seizure of thousands of counterfeit drugs that would otherwise have entered the supply chain with serious consequences. Additional information is available in the technical note:
Handheld Analyzers for the Rapid and Accurate Screening of Counterfeit Pharmaceuticals.
Featured NIR white paper and article
Determination of Moisture in a Protein Sample Using a Portable NIR Instrument - In this feasibility study the performance of a portable NIR instrument was evaluated to monitor moisture levels within a protein sample, as proof of concept to monitor lyophilized samples in a pharmaceutical process.
Rapid Method for Moisture Content in Sodium Chloride Salt Using a Portable Spectrometer - While ingress of moisture into salts is easily recognized by an increasing propensity to form clumps, it is difficult to measure them quickly. The handheld NIR can be used to determine the water content in buffer salts. This rapid and effective determination of water content is key in assessing buffer salts’ suitability for use during biologics manufacturing.