EKG Labs is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. We excel at providing analytical and regulatory services which enable our clients to fulfill complex regulatory requirements and to bring their product to market faster.
We utilize our strengths in regulatory compliance, scientific excellence and novel thinking to offer Scientific and Regulatory Consultation, FDA Response/Remediation, Program Management and Execution.
Our focus is in the support of challenging analytical work such as impurity identification, extractable/ leachable programs, contaminant identification, characterization analyses and method development/ validation.
Extractables and leachables (E&L) studies are in-depth analytical investigations of the chemical interactions between a container closure or drug delivery system, its packaging components, and a drug product or pharmaceutical formulation. The primary purpose of the investigation is to identify any potential chemicals derived from the interaction of the constituent parts and then to determine the impact to human health and/or efficacy that those chemicals pose. This identification is an extractables/leachables profile. Organizations that seek to provide guidance for E&L studies include the FDA, ICH, and USP.
What are Extractables?
Extractables are substances in a device or container closure system which can be “pulled out” using stressing conditions such as strong solvents, elevated temperatures, and/or increased surface area. Substances observed in this stage are characterized and identified per FDA guidelines and further evaluated by a toxicologist to determines if the substance is a potential hazard. Common extractables include plasticizers, surfactants, processing aids, degradants, and container closure system materials.
What are Leachables?
Leachables are substances in the device or container closure system that leach or “come out” under normal conditions of exposure over the natural lifespan of a product. Sources of leachables are potentially numerous and can include ink and adhesives from labels or secondary packaging material. FDA guidelines monitor known extractables and leachables to ensure human exposure levels do not exceed appropriate safety limits.
Extractables and Leachables Studies at EKG Labs
Understanding the complex chemical interactions between pharmaceuticals and materials is critical to designing a proper extractables and leachables program. The head of our analytical team, Dr. Allen Kesselring, is known throughout the medical device development industry for designing and managing large E&L programs. We can perform E&L analytical studies with the ultimate goal of submitting data for FDA review and approval. EKG Labs is familiar with guidance from organizations such as ICH and USP. Our capabilities include:
Extractables and Leachables Analytical Techniques at EKG Labs
Impurity identification is the process of elucidating the nature of unknown materials in combination products, medical devices, pharmaceuticals, or consumer products using a variety of analytical techniques. Three groups of impurities typically evaluated during impurity identification are organic impurities, inorganic impurities, and residual solvents. Sources of these impurities can come from the manufacturing process and/or storage of material. Examples of impurities include: starting raw materials, by-products, intermediates, degradants, reagents, ligands, catalysts, heavy metals, residual metals, or any other materials or process aids in the production process.
In any product, impurities can delay development or can cause a recall of a product on the market. Impurity analysis is critical in medical device and pharmaceutical development because impurities can impact the safety and efficacy of final therapeutic products. Various organizations such as the FDA and ICH provide recommendations regarding testing for impurities and acceptable impurity limits in a medical device or pharmaceutical product.
Impurity Identification Services at EKG Labs
EKG Labs provides impurity identification and characterization services to the medical device, pharmaceutical product, and consumer product industries. We have the analytical instrumentation and experience to isolate, analyze, and identify impurities. EKG Labs can perform impurity identification in accordance with FDA and ICH guidelines. Once an impurity is identified, EKG Labs has the ability to have a reference standard prepared and characterized. We can also develop and validate a method in order to monitor the impurity.
In some cases, chemical impurities develop when a device, pharmaceutical, or other product is stored for a long time. The formation of these degradants is impacted by temperature, humidity, light, and contact with other substances. At EKG Labs, we can help customers simulate a variety of these conditions through stability programs to develop an impurity profile. We can then monitor the formation of impurity degradants and help determine if the chemical degradation is a potential concern for the safety or efficacy of the product.
EKG Labs also provides problem solving services to identify the source of the impurity such as analyzing raw material or investigating various aspects of the manufacturing process itself. At EKG Labs we work with you to provide a customized solution to your impurity identification and analysis needs.
Analytical Techniques for Impurity Identification
According to FDA guidance, method development is an activity designed to create an analytical procedure “to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic.” Additionally, even in cases where method development may be performed for non-regulatory purposes, it can be very important to develop a method with an eye toward validating it in the future. This can save significant time and resources in future validation activities. The FDA recommends the inclusion of the following parameters in a method development study: specificity, linearity, limits of detection and quantitation (LOD and LOQ), range, accuracy, and precision.
Method Development Services at EKG Labs
Method development is the cornerstone of medical device and pharmaceutical development. It is often one of the first steps in identifying and understanding the chemical nature of a target molecule or material. It can also be used to identify potential impurities or degradants in a formulation. At EKG Labs we develop methods for a wide range of analytical techniques and materials. We also provide method validation services for methods developed both in-house and externally.
Chemical characterization is the process of defining the chemical properties of one or more components of a substance or device material. Characterization techniques are used for a variety of reasons such as identifying device materials, detecting the presence of impurities and degradants, or creating a chemical profile of an unknown formulation. Characterization can also be a valuable first step before performing a more intensive impurity identification study by eliminating some variables from the investigation.
Chemical Characterization at EKG Labs
EKG Labs provides characterization services for a variety of materials and products. We have helped companies tackle analytical challenges for both medical devices and pharmaceutical products. We perform medical device characterization in accordance with ISO 10993 guidance for the delivery apparatus and other components of interest. Additional characterization capabilities include determining the presence of a new contaminant in a product and characterizing new drug formulations in preparation for validating an analytical method. We have experience characterizing a variety of materials including:
Chemical Characterization Techniques at EKG Labs
A partial FDA definition for a medical device is, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” From this definition it is evident that a medical device can cover a wide variety of uses and applications. Medical device development means not only engineering a device that is physically and chemically sound but also navigating the complex regulatory hurdles put in place to keep people safe.
EKG Labs is an industry expert in providing medical device development support services. We provide a variety of services that help describe device performance characteristics of a medical device product. One of our specialties is providing analytical services that support the development of medical devices that are implanted or come into contact with the human body. We provide services that help our clients answer questions like:
Our medical device development services include:
EKG Labs Medical Device Development Service Expertise
EKG Labs Material Expertise
We have experience providing services for diverse materials in a variety of medical device products. These materials include:
Medical device material compatibility is the understanding of whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of an overall device. As medical devices become more complex and use a greater variety of materials, the potential for negative interactions increases. Therefore, there is a growing emphasis on investigating the interaction between individual device material components prior to performing efficacy and performance testing on a “complete” device.
Material Compatibility Analytical Services at EKG labs
EKG Labs provides medical device material and pharmaceutical compatibility testing services to support device development activities. The team at EKG Labs has years of experience understanding the diverse reasons why device materials can fail and why some materials are not compatible with others. We work with clients to understand how prospective materials may interact, and we provide data to help them choose the best materials to use in their medical device or combination product. We accomplish this through a variety of analytical techniques which stress materials under controlled or accelerated conditions. Depending on the project goals, this data can be used to flag potential material incompatibility or to find material combination options that pose the least amount of risk of causing a medical device failure. EKG Labs has worked on a wide variety of medical devices and materials for diverse therapeutic areas.
Combination product biocompatibility is the analysis of a combined container closure or delivery system with a pharmaceutical drug product when in contact with, or in, the human body. In many ways these investigations combine aspects of standard extractables and leachables and biocompatibility studies. Essentially, the drug component of the combination product adds additional chemical variables to the medical device profile which needs to be evaluated. Like other biocompatibility studies, the ISO 10993 standards are referenced as guidance for these studies. These drug device combination products are among the most most challenging products to submit to the FDA for review. As such, these combination medical devices require extensive forethought and planning for product testing and analysis.
Combination Product Biocompatibility at EKG Labs
EKG Labs leverages its knowledge of extractables, leachables, and biocompatibility to help companies develop combination products and devices for FDA approval. Our team has years of experience working with a wide variety of combination devices, materials, and pharmaceutical products. This includes applying ISO 10993 biocompatibility testing criteria across many combination products. We also have a firm understanding of how to characterize common and novel medical device materials and flag any materials which need further toxicological evaluation or analysis. EKG Labs further supports combination drug device analysis through regulatory consulting services and can help you navigate the complex FDA regulatory process.
Combination Medical Device Material Expertise:
Combination Device Experience:
Combination Product Biocompatibility Analytical Techniques
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