The expectations of manufacturers are developing rapidly in terms of evaluating the packaging and distribution systems of drugs and the surfaces used during production according to potential leaks. Today, every new drug product is leachable and extractable. (can be leached and extracted) substances are tested and evaluated.
Extractable Substances are chemical compounds from a primary container or component material that can contaminate the drug and cause a variety of potential problems. They are often produced over time between drugs and their packaging, often under extreme conditions such as the presence of strong solvents or the interaction between high temperatures.
Leachable substances, elastomeric or plastic components, or compounds that leach into the drug from the coatings of the container and closure system. Leakage is the result of direct contact with the formulation under normal conditions of use. Exudates are generally a subset of extractables.
When choosing sample storage tubes it is important to understand the difference between extractables and leachables. Both of these negatively affect product quality due to poor production techniques.
Extractable substances are compounds that can be extracted from a packaging component, delivery system, or production surfaces during laboratory work, such as exposure to solvents or heat. These could be potential leaks. Leachable substances are compounds that passively migrate to the drug over time as a result of direct contact from the packaging system, components in use, or a production surface.
The most frequently performed tests and evaluations in advanced laboratories are:
In addition to these assessments, studies for drug delivery systems, simulation studies and migration studies on secondary packaging such as labels, inks and paints are also carried out.
Leachable and extractable assessments are made after production runs are complete (during Phase III Therapeutic validation). The most common phase for primary packaging is at the end of the Phase II Therapeutic discovery phase. However, it is not correct to start these studies earlier, provided the packaging components or the production sequence have been completed. However, leachable and extractable considerations can be made to support the ingredient selection process.
The choice of method to be followed during design studies depends on the component to be evaluated, the formulation of the drug, route of administration, dosage regimen, and safety.
Leachable substances are always found in a low quality sample storage tube. Extractable substances are only available after gamma irradiation to sterilize tubes produced in a non-sterile environment.
Our organization carries out very different testing, analysis, measurement, control and evaluation activities for businesses in various sectors. In these studies, it always follows domestic and foreign standards and applicable legal regulations. Our organization, which has a trained and experienced staff and advanced technological facilities, also provides leachable and extractable drug testing services within the scope of medical drug tests to companies that request it.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
