Element’s contamination detection and analysis services rapidly isolate and identify unknown particulates and contaminants in pharmaceuticals, biologics, specialty chemicals, and consumer products 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.
Consumer product and specialty chemical contaminant testing
Thorough testing of materials, both precursors and finished products, must be carried out by manufacturers in order to ensure the consistency, safety, and efficacy of products. This includes ensuring products are free of contaminants. Consumer Products must be tested to ensure no substances of concern are present. Product packaging materials and/or product containers, such as glass, rubber, aluminum, plastic, and paper particles, are also potential sources of contamination. 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.
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, 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, and finished products. 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 complaint investigation services.
Biopharmaceutical and pharmaceutical contaminant testing
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. Identify the source of any foreign particulate matter. with our comprehensive biologics contaminant testing and pharmaceutical contaminants analysis solutions. We 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.
Detect, isolate, and identify contaminants, precipitates, and unknown impurities, as well as their source. Partner with Element to identify contaminants to trace-level limits of detection - our experts work alongside your staff to identify potential sources of unknown foreign materials and contamination, including raw materials, manufacturing processing aids, filling, and packaging lines. Together, we'll prevent and minimize the risk of potential contamination with quality control checks and comprehensive analytical support, such as batch-to-batch testing, refined product development methods, raw material testing, and more. Ready to start the conversation? Fill out a short form and a member of our team will be in touch with you shortly.
Contaminant detection and analysis methodology and instrumentation
Our 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 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
Our flexible and customized 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 to determine the source of contamination. With a proven track record of success carrying out 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.
Biopharmaceutical and pharmaceutical contaminant testing services
To explore our comprehensive contaminant testing service offerings for pharmaceuticals and biologics, click "More". Ready to start the conversation? Click "Request Information" and fill out a short form. A member of our team will be in touch with you shortly.
Glass delamination in pharmaceutical containers
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
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. 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
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
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
Element can isolate and identify stains, discoloration, and residue, even in cases where minimal amounts of sample are available.
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
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.
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.