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 checksand wraparound services, such as batch-to-batch testing, refined product development methods, raw material analysis, and more. Talk to an expert todayto 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 speciationanalysis, elemental impurities testingto ICH Q3Das well asUSP <232> and USP <233>, in addition to customized multi-element analyses, from multi-analyte assays and methods for heavy metals to trace elemental analysisquality 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>.
– 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) spectroscopyand 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 ourexperts, contact us today.
Contamination is defined as the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (Active Pharmaceutical Ingredient) during production, sampling, packaging or repackaging, storage or transport.How do you identify Pharma contamination? ›
Microscopical analysis is particularly well suited to the analysis of particulate contamination because the particles are usually too small to be analyzed using conventional methods. Proper methods of sample isolation and preparation are also critical to the successful pharmacuetical contamination identification.What are the major pharmaceutical contaminants? ›
Common types of pharmaceutical contamination
Chemical Contaminants: Moisture, gases, vapor or molecules may also contaminate sterile pharmaceutical products. Biological Components: These include viruses, bacteria, or fungi that can cause diseases and should not be found in pharmaceutical products.
There are three main types of contamination to consider in pharmaceutical manufacturing and transportation. When you think about types of contaminants, consider which category they may fall into and how dangerous they may actually be.What are the 4 types of contaminants? ›
Food manufacturers must do everything possible to avoid contamination and produce safe products, knowing the dramatic consequences if they don't. There are four types of food contamination: physical, biological, chemical and allergenic. This blog explains these categories and provides tips on how to avoid them.What are the 3 types of contamination? ›
While there are many food safety hazards that can cause food contamination, most fall into one of three categories: biological, physical or chemical contamination. In many cases, a single hazard can introduce more than one type of contamination to food.How do you test for contamination? ›
- Ion Chromatography (IC) ...
- Scanning Electron Microscopy / Energy Dispersive Spectrometry (SEM/EDS) ...
- Inductively Coupled Plasma / Atomic Emission Spectroscopy (ICP/AES) ...
- Fourier-Transform Infrared Spectroscopy (FTIR)
- Use separate equipment for raw and ready-to-eat food. ...
- Properly clean and sanitize before and after tasks. ...
- Prep raw and ready-to-eat-food at separate times. ...
- Buy food that's already been prepared.
- industrial chemicals.
- agricultural chemicals.
- toxic metals.
- naturally occurring toxins.
Examples of chemical contaminants include nitrogen, bleach, salts, pesticides, metals, toxins produced by bacteria, and human or animal drugs.
- Nitrates. ...
- Arsenic. ...
- Microorganisms, Bacteria, and Viruses. ...
- Aluminum. ...
- Fluoride. ...
- What Can Be Done About Contaminants in Tap Water? ...
- Frequently Asked Questions.
- waste from factories.
- contaminated land, including from natural occurrence.
- contaminated water, for example, dioxins, halogenated organic compounds or heavy metals.
Contamination is the presence of any foreign substance in our products. It may be: Physical: hair, foreign objects, dirt, dust, pollens. Chemical: cleaning agents, lubricants, other products. Microbiological: bacteria, moulds, spores, yeasts.What is the most common method of contamination? ›
- Nose, mouth, or eyes to hands to others: Germs can spread to the hands by sneezing, coughing, or rubbing the eyes and then can be transferred to other family members or friends. ...
- Hands to food: ...
- Food to hands to food: ...
- Infected child to hands to other children: ...
- Animals to people:
- Dioxins and PCBs.
- Per- and Polyfluoroalkyl Substances (PFAS)
Summary. Food products are rich in nutrients required by microorganisms and may become contaminated. Major contamination sources are water, air, dust, equipment, sewage, insects, rodents, and employees.What are 3 ways to prevent contamination? ›
To prevent this: Wash hands with soap and hot water before and after handling food, and after using the bathroom, changing diapers; or handling pets. Use hot, soapy water and paper towels or clean cloths to wipe up kitchen surfaces or spills. Wash cloths often in the hot cycle of your washing machine.How many types of contaminants are there? ›
The U.S. EPA has set standards for more than 80 contaminants that may occur in drinking water and pose a risk to human health. The contaminants fall into two groups according to the health effects that they cause.What are the 4 phases of assessment for contaminated sites? ›
From a reporting perspective, contaminated sites management can be broadly classified into the following stages: 1 – Preliminary site investigation 2 – Detailed site investigation 3 – Site remedial action plan 4 – Site validation and ongoing monitoring.How is PCR contamination detected? ›
The direct comparison of PCR product sequences from a sample and a control is the best way to determine whether two PCR products are similar or different. After comparison of the DNA sequence variation between the PCR products and the control, the cross contamination of samples can be detected.
ABSTRACT. The four main targets for drug action: receptors, ion channels, enzymes, carrier molecules. In each of these four cases, most drugs are effective because they bind to particular target proteins.What are the types of pharmaceutical impurities? ›
The three different types of impurities in pharmaceuticals include organic, inorganic, and residual solvents. Most of these impurities occur due to manufacturing processes, degradation, storage conditions, excipients, or contamination.What are 5 examples of cross contamination? ›
Some examples are: Touching raw meats then handling vegetables or other ready-to-eat foods without washing hands between tasks. Using a food soiled apron or towel to wipe your hands between handling different foods. Failing to change gloves between handling different foods.Which 6 measures will prevent cross contamination? ›
- use different utensils, plates and chopping boards for raw and cooked food.
- wash utensils, plates and chopping boards for raw and cooked food thoroughly between tasks.
- make sure you do not wash raw meat.
- wash your hands after touching raw food and before you handle ready-to-eat food.
- using the same knife or chopping board to cut both raw and ready-to-eat foods.
- using the handwash basin for defrosting food or placing dirty utensils and equipment.
- storing food uncovered or on the floor of the fridge or freezer.
- storing raw food above ready-to-eat food.
Industrial, agricultural, mining, logging, urban and residential activities and related development: These land uses are all potential non-point sources of toxic chemicals. Chemicals in smoke stack emissions can spread widely across the landscape or region (Figure 5).Which is the best example of a contaminant? ›
Common examples of physical contaminants include hair, bandages, fingernails, jewelry, broken glass, metal, paint flakes, bone, the body parts of pests, or pest droppings.What is contaminant with example? ›
The Safe Drinking Water Act (SDWA) defines "contaminant" as any physical, chemical, biological or radiological substance or matter in water. Drinking water may reasonably be expected to contain at least small amounts of some contaminants. Some contaminants may be harmful if consumed at certain levels in drinking water.What's another word for contaminant? ›
Some common synonyms of contaminate are defile, pollute, and taint. While all these words mean "to make impure or unclean," contaminate implies intrusion of or contact with dirt or foulness from an outside source.What are the sources of contamination? ›
- Airfield and fire training areas.
- Buried waste.
- Detonation areas.
- Disposal pits or trenches.
- Drums and containers with chemical substances.
- Emission stacks and vents.
The reasons for contamination can include:
- poor waste management.
- poor construction, industrial or agricultural practices.
- illegal dumping or unsafe storage of harmful products.
Contamination analysis can require a wide range of techniques to detect, identify and investigate contamination and extraneous matter investigations. Contamination can cause major disruption to your production or distribution and the correct analytical methods must be applied to achieve a rapid resolution.What is the process of contamination? ›
Process contaminants are undesired chemical by-products that can form during food processing, especially when heating, drying, or fermenting foods. They can form during home cooking and in manufacturing facilities, and in some cases, low levels may be unavoidable.What technique is used to prevent contamination? ›
Aseptic technique, a method used to prevent contamination with microorganisms, is recommended by the evidence-based guidelines for all instances of insertion and care of central venous catheters.What is the most common laboratory contaminant? ›
The most common biological encountered contaminates are bacteria, molds, yeasts, viruses, mycoplasma, as well as cross contamination by other cell lines. This review provides an overview of major critical source and control options of contaminants.What are the two methods of contamination removal? ›
Decontamination methods either (1) physically remove contaminants, (2) inactivate contaminants by chemical detoxification or disinfection/sterilization, or (3) remove contaminants by a combination of both physical and chemical means.What does contaminant mean? ›
Britannica Dictionary definition of CONTAMINANT. [count] : something that makes a place or a substance (such as water, air, or food) no longer suitable for use : something that contaminates a place or substance.What a contaminant means? ›
A contaminant is something that contaminates a substance such as water or food. [formal] Contaminants found in poultry will also be found in their eggs. We are exposed to an overwhelming number of chemical contaminants every day in our air, water and food.What are pharmaceutical contaminants in water? ›
These can include: pharmaceuticals and personal care products, organic wastewater compounds, antimicrobials, antibiotics, animal and human hormones, endocrine disrupting compounds, as well as a variety of domestic and industrial detergents.What is called contaminant? ›
Contaminants are defined as “substances (i.e. chemical elements and compounds) or groups of substances that are toxic, persistent and liable to bioaccumulate, and other substances or groups of substances which give rise to an equivalent level of concern”.
Examples of chemical contaminants include nitrogen, bleach, salts, pesticides, metals, toxins produced by bacteria, and human or animal drugs. Biological contaminants are organisms in water. They are also referred to as microbes or microbiological contaminants.What is an example of contamination? ›
Examples of Physical Contamination
Common examples of physical contaminants include hair, bandages, fingernails, jewelry, broken glass, metal, paint flakes, bone, the body parts of pests, or pest droppings.
Most Common Types of Chemical Contamination
Some of the most common examples of chemical contamination include: Cleaning products and disinfectants. Unwashed fruit and vegetables. Chemicals from the use of non-safe plastics.
There are four main types of contamination: chemical, microbial, physical, and allergenic. All food is at risk of contamination from these four types. This is why food handlers have a legal responsibility to ensure that the food they prepare is free from these contaminants and safe for the consumer.What is the difference between contaminant and contamination? ›
contaminant means any biological or chemical agent, foreign matter, or other substances that may compromise food safety or suitability. contamination means the introduction or occurrence of a contaminant in food.What are the 5 main contaminants of water? ›
Among the top contaminants in your drinking water are nitrates, bacteria and viruses, arsenic, fluoride, and lead.What are the 3 main impurities in water? ›
- Suspended impurities like clay and sand particles.
- Harmful bacteria.
- Mineral salts.
Some common synonyms of contaminate are defile, pollute, and taint. While all these words mean "to make impure or unclean," contaminate implies intrusion of or contact with dirt or foulness from an outside source.How can you prevent contamination? ›
Keep it clean:
Wash hands with soap and hot water before and after handling food, and after using the bathroom, changing diapers; or handling pets. Use hot, soapy water and paper towels or clean cloths to wipe up kitchen surfaces or spills. Wash cloths often in the hot cycle of your washing machine.