Element’s contamination detection and analysis services rapidly isolate and identify unknown particulates and contaminants in pharmaceuticals and biologics down to trace levels, in addition to determining the source of contamination and providing wraparound services to minimize the risk of potential contamination in the future.
The US Food and Drug Administration (FDA) mandates that contaminants in products and process streams are immediately and thoroughly investigated. Thorough testing of materials, processes, equipment, techniques, environments, and personnel must be carried out by drug manufacturers in order to ensure the consistency, safety, and efficacy of products. This includes ensuring products are free of contaminants. Particulate contamination in pharmaceuticals and biologics may result from a variety of sources, from the active pharmaceutical ingredient (API) and/or excipients to colorants. Product packaging materials and/or product containers, such as glass, rubber, aluminum, plastic, and paper particles, are also potential sources of contamination. Additionally, drug product contamination can occur during the manufacturing process. Our team of seasoned experts can quickly and thoroughly assess your particular product or manufacturing issue, applying a stepwise and fine-tuned approach, successfully identifying the source of any foreign particulate matter. Our comprehensive biologics contaminant testing and pharmaceutical contaminants analysis solutions support out-of-specification (OOS) investigations, in addition to material and product failures, pharmaceutical product quality complaints, manufacturing and process issues, client and consumer complaints, quality control problems, and transport and handling cross contamination.
Element’s experienced analytical and material scientists rely on their deep material science expertise and a broad range of advanced analytical instrumentation to isolate and identify contaminants, employing various analytical methodologies to effectively detect, isolate, and identify contaminants, precipitates, and unknown impurities, as well as their source. In addition to identifying contaminants with trace-level limits of detection, our consultative team will work with your staff to identify potential sources of unknown foreign materials and contamination, including raw materials, manufacturing processing aids, filling, and packaging lines. Prevent and minimize the risk of potential contamination in the future with robust quality control checks and wraparound services, such as batch-to-batch testing, refined product development methods, raw material analysis, and more. Talk to an expert today to explore Element’s contaminant analysis and pharmaceutical complaint investigation services.
Biopharmaceutical and pharmaceutical contaminant testing services
Glass delamination in pharmaceutical containers – The United States Pharmacopeia (USP) defines glass delamination as the appearance of very thin glass flakes, or lamellae, that are generated by deterioration of the inner glass vial wall in USP <1660> guidance. Glass delamination in parenteral and pharmaceutical vials is a major concern for the biopharmaceutical industry, as the presence of glass lamellae in parenteral drug products has led to several high-profile product recalls. Element has extensive experience and deep expertise in pharmaceutical vial delamination testing and screening for glass delamination to USP <1660>.
Identification and characterization of particulates – Particulates can form as a result of the product formulation. Although particulates can be related to a variety of formulation components, oftentimes, these particulates are related to the API. Changes in crystal structure (polymorphism), pH, degradation, or other types of reactions can be the root cause of particulate formation. Furthermore, the control of particulates is critical to the safety of biologic drug products. Under specific conditions, protein aggregates can form an insoluble particulate in biologically derived drugs. Element’s highly skilled scientists have a great deal of experience identifying and characterizing particulates, including particulate shape, morphology, and color. Our regulatory and scientific experts have experience testing injectable drug products to USP <788>, Ph.Eur./EP 2.9.19, and JP 6.07, as well as testing biologics to USP <787>.
Elemental profiling of particulates – Trace metal and elemental profiling of particulates and contaminants is critical to product development, quality control, and regulatory compliance. As elemental contamination can take many complex forms, partnering with an elemental contaminant testing lab is critical to identifying elemental particulates and contaminants, as well as implementing effective solutions to control and prevent metals contamination in a wide range of materials, products and processes. Element’s complete trace and ultra-trace metals testing and analysis services include metals speciation analysis, elemental impurities testing to ICH Q3D as well as USP <232> and USP <233>, in addition to customized multi-element analyses, from multi-analyte assays and methods for heavy metals to trace elemental analysis quality control (QC) programs.
Isolation, characterization, and identification of precipitates – When non-crystalline, amorphous material(s) precipitate from a drug delivery system, it can result in both the dissolution and bioavailability of the drug being compromised. Element’s knowledgeable scientists have extensive experience analyzing pharmaceutical solutions to isolate, identify, and characterize precipitates, in addition to having the ability to identify and distinguish immiscible phases from solids.
Contaminant particle size and count –The identification of particles and their true particle size can be particularly valuable when contaminant investigations determine multiple particle types are present in a pharmaceutical product. Element’s contaminant and particulate analysis services include the measurement of particle counts, particle size, and size distribution.
Identification of foreign matter – The detection and identification of foreign particulate matter in pharmaceuticals is critical to quality control and the product development process. As the origin and nature of foreign matter in biopharmaceuticals can vary greatly, a variety of techniques and methodology may need to be used to locate, isolate, analyze, and identify the contaminant(s). This may include chemical analysis, physical characterization such as surface area and porosity, and mechanical testing. Element has deep expertise and experience analyzing a myriad of materials and carrying out forensic investigations for the pharmaceutical industry.
Residue, stain, and discoloration analysis – Regardless of whether drug product is functionally impacted by residue on vials, stains on tablets, or discoloration in pharmaceuticals, these issues can result in costly delays and product recalls. There are multiple potential sources of discoloration and staining of pharmaceuticals, including manufacturing processes or packaging materials that have resulted in unanticipated interactions. Exposure to environmental conditions, such as light and air, can sometimes cause molecular conversion, leading to changes in color. Element can isolate and identify stains, discoloration, and residue, even in cases where minimal amounts of sample are available.
Impurity identification – In order to ensure the safety, quality, and purity of drug substances and finished products, impurities and unwanted compounds must be identified and controlled. A wide range of sources can introduce impurities, from the degradation of API and/or excipients to manufacturing processes and container-closure systems. Element’s complete drug product impurity testing solutions include testing to ICH Q3A and ICH Q3B, as well as USP <1086> and USP <476>.
Extractables and leachables (E&L) studies – The safety and/or efficacy of drugs and pharmaceuticals may be altered by potentially harmful organic and inorganic impurities that can migrate into finished products from container-closure systems and product packaging or delivery devices, or manufacturing components and equipment. Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world. Our in-depth knowledge of regulatory guidance, materials science, and advanced equipment have provided the foundation for the industry-leading, comprehensive E&L services we provide.
Contaminant detection and analysis methodology and instrumentation
Our pharmaceutical contamination services are tailored to your needs, which includes using a wide range of instrumentation and methodology. We can detect volatile and semi-volatile compounds, as well as perform a variety of non-volatile analyses on a broad range of molecular weights. Element’s analytical scientists can develop analytical methods to detect trace organic contaminants in a range of sample matrices, as well as assay for potency and purity of active ingredients or excipients. Internationally recognized standardized methods can be applied, analytical methods can be transferred, or existing methods may be applied. Furthermore, we can develop appropriate analytical methods, qualitative and/or quantitative, and if needed, validate methods to ICH Q2 regulatory guidelines, or other applicable standards or regulations. Advanced instrumentation and techniques include:
- Light Microscopy
- Micro-Fourier Transform Infrared (Micro-FTIR) spectroscopy and Raman spectroscopy, with a large FTIR spectral database
- Scanning Electron Microscopy (SEM) coupled with Energy Dispersive X-Ray Spectroscopy (EDS), 3D imaging available
- Liquid Chromatography (LC), with diode-array detectors
- Gas Chromatography (GC), with liquid and headspace sampling, as well as flame ionization detection (FID)
- Quadrupole/Time of Flight Tandem Mass Spectroscopy (Q-TOF)
- Nuclear Magnetic Resonance (NMR)
- X-Ray Diffraction (XRD)
The Element advantage
Protect patient safety and ensure product quality, efficacy, and compliance to regulatory guidance with Element’s comprehensive contaminant analysis services. Our flexible and customized biopharmaceutical contaminant testing solutions vary from characterizing contaminants to determining the source of contamination with a variety of analytical instrumentation and techniques. Raw materials, reagents, processing aids, and suspect reference materials (e.g., mixing blades, rubber gaskets, O-rings, and lubricants) can be analyzed in order to determine the source of contamination. With a proven track record of success carrying out pharmaceutical complaint investigations and preventing contamination issues by supporting manufacturer’s modifications of their processes up to - and including - full process revalidation studies, our engaged experts will work alongside you to improve processes and prevent contamination issues. We also offer remote SEM sessions, which can be particularly useful for collaborative problem solving, especially if your in-house experts have knowledge of the suspect materials.
To learn about our biopharmaceutical contaminant investigation and pharmaceutical contaminant identification testing services, or to speak with one of our experts, contact us today.
Trace Metal Services
Element is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP, EP (2.4.20), and ICH Q3D guidelines.
Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
Excipient Raw Materials and Container Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
NMR spectroscopy in pharmaceutical analysis enables identification of substances and impurities, verification of chemical synthesis and compound characterization, supporting critical stages of pharmaceutical development.