Below you'll find a list of all posts that have been categorized as “Case Studies”
Elemental Extractables for Medical Devices The International Organization for Standards (ISO) describes the requirements for medical device biocompatibility testing in great detail in their well-established guidance ISO 10993: Biological evaluation of medical devices. Part 18 of this guidance, “Chemical characterization of medical device materials within a risk management process” specifically …
A Refresher on USP <1664> Pharmaceutical leachables are chemical entities from packaging or delivery systems which migrate into a drug product under normal storage conditions, potentially impacting the safety or efficacy of the drug. The primary United States Pharmacopoeia (USP) chapter directing leachable testing is USP <1664> “Assessment of Drug Product …
Impurity Investigations Chemical impurity analysis is critical in pharmaceutical and medical device development because impurities can impact the safety and efficacy of final therapeutic products. Examples of chemical impurities include: starting raw materials, by-products, intermediates, degradants, reagents, ligands, catalysts, heavy metals, residual metals, or any other materials or process aids …
With an ever-increasing emphasis across the medical device industry on chemical characterization via ISO 10993, and the 2020 update to ISO 10993-18, more and more companies are finding themselves required or “encouraged” to perform extractables and leachables testing on medical devices which previously sailed through regulatory hurdles. For example, EKG Labs has recently …
Biodegradable/bioabsorbable polymers degrade in vivo to biocompatible and toxicologically safe by-products that are removed via normal metabolic pathways. These polymers are used in implanted medical devices whose purpose is to provide a physical structure to assist healing and/or to act as a delivery mechanism for a therapeutic purpose. EKG leverages our knowledge …
Drug-Delivery Pumps: An EKG Labs Case Study Last month, we shared how EKG Labs is leading the way in analytical testing of drug delivery pumps. EKG leverages our knowledge of material compatibility, extractables & leachables, and ISO 10993-18 chemical characterization to help clients submit drug-device products for regulatory approval. This month we wanted highlight a …
Impurity Identification Chemical impurity analysis is critical in medical device and pharmaceutical development because impurities can impact the safety and efficacy of final therapeutic products. Examples of chemical impurities include: starting raw materials, by-products, intermediates, degradants, reagents, ligands, catalysts, heavy metals, residual metals, or any other materials or process aids …
An Introduction to Elemental Impurities Elemental impurities analysis encompasses trace metal/heavy metal testing to evaluate pharmaceutical products for elevated concentrations of elements that are of significant toxicological concern. Based on ICH Q3D guidelines, the USP has published general chapters <232> “Elemental Impurities — Limits” and <233> “Elemental Impurities — Procedures”. …
EKG Labs is excited to share our first publication in the Journal of Pharmaceutical and Biomedical Analysis (Volume 187), published in collaboration with FHI 360. FHI 360 is an international nonprofit promoting lifesaving health care in over 60 countries. The paper, “Forced Degradation Studies of Medroxyprogesterone Acetate Injectable Suspensions (150 mg/ml) …
How efficient are your extractions? As an industry-recognized medical device testing provider and an experienced conductor of extractables and leachables studies on a wide variety of pharmaceutical products, EKG Labs has encountered a number of unique extraction challenges. EKG’s Extraction Methods In order to ensure we are providing our clients with the highest quality …
Why are cell culture media important? A cell culture is developed when cells, tissues, or organs (whether animal or plant in origin) are placed into artificial environments conducive to their survival and/or proliferation.1 Cell culture technology is used in the manufacture of biologic drugs (or “biopharmaceuticals”) and vaccines as well …
EKG Labs performed a short-term stability study specifically to evaluate several additives in a nutrient solution with surgical applicability. After finishing an extensive literature search to get a sense of compound stability and establish starting points for some of the more challenging additives to analyze, EKG developed a minimal number …
Many of the projects EKG Labs takes on require at least some element of method transfer, whether with or without additional development. Method transfer projects requiring regulatory elements generally fall into one of three categories. Method Verification: An externally validated method or a compendial method is directly transferred under EKG standard …
What are PAHs? Polycyclic aromatic hydrocarbons (PAHs) are a class of organic compounds produced by incomplete combustion of complex organic molecules. PAHs are ubiquitous in the environment (air, soil, food, water, etc.) because they are commonly released in car exhaust or by burning fossil fuels and trash. In general, a …
Why are deuterated drugs important? Deuterium (“heavy hydrogen”) is a stable, non-radioactive isotope of hydrogen with one proton, one neutron, and one electron. Deuterium thus effectively has twice the mass of hydrogen. In the pharmaceutical industry, some drugs have one or more of the hydrogen atoms in the molecule replaced …
Introduction to Heavy Metals: Elemental impurities analysis encompasses trace metal/heavy metal testing to evaluate pharmaceutical products for elevated concentrations of elements that are of significant toxicological concern. Based on ICH guidelines, the United States Pharmacopoeia (USP) has published general chapters <232> “Elemental Impurities — Limits” and <233> “Elemental Impurities — …
Inhalation products—which include metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulized solutions/suspensions, and nasal sprays — are drug-device combination products that incorporate drug products, drug delivery devices, and container closure systems. Due to the complex nature of these devices, risk assessments and subsequent extractable and leachable (E&L) analysis can …
As the FDA continues to expand regulation of polymeric materials associated with medical devices and pharmaceuticals, extractables and leachables studies and impurity investigations are becoming more critical than ever. While typical polymer additives of concern include antioxidants, stabilizers, lubricants, plasticizers, and colorants, adhesive-specific impurities should not be overlooked. For example, …
In recent months, microneedle patches have been making headlines as a potential future in drug delivery systems. Because only cosmetic microneedle patches are currently widely available and are not approved by the FDA, there is little information about the extractable profile of these devices. However, as these patches gain traction …
Introduction: Leaching occurs under normal storage conditions, when chemicals from a delivery device or packaging migrate into a drug substance, potentially impacting its safety or efficacy. Consequently, regulatory bodies often require in-depth analytical investigations into the leachable profile of a drug product’s packaging components to ensure patient safety. Often an …
Introduction: Leachables are chemical entities that migrate from one material matrix into another. In medical device and pharmaceutical development, leaching occurs under normal storage conditions, when chemicals from a delivery device or packaging migrate into and potentially impact the safety or efficacy of a drug substance. Consequently, regulatory bodies often …
Introduction: Co-eluting impurities are two or more chemical entities that elute, or come out, at similar or equivalent retention times when analyzed by chromatographic techniques such as HPLC and GC. Co-eluting impurities can pose several challenges to product development. For example, co-eluting impurities can cause an “exaggerated” response. This is …
