Risk Assessment
A risk assessment serves as a safety road map for a product. It details the materials of construction, product composition, manufacturing processes, and storage conditions throughout the lifetime of the product, and outlines the associated risks and mitigation strategies.
Our team offers a detailed risk assessment as a standard first step on your E&L journey. During a risk assessment, the materials used in the product and packaging, manufacturing system, or medical device are documented. The materials that come into contact with the product are then evaluated using Failure Mode Effects Analysis (FMEA) and risk scoring. Once risk levels are determined for the product, our team will provide you with a mitigation plan in compliance with the relevant regulatory standards for your desired market.
Risk Factors
- Solvents or certain additives in the product can increase the likelihood of harmful compounds leaching from polymers or elastomers into the product.
- Liquid products, even water-based products, can constitute an increased risk in comparison to a solid formulation.
- Missing certifications or information for a product/packaging/device’s materials of construction represent unknowns and therefore sources of potential risk.
- Environmental conditions that the product is exposed to during manufacturing or storage, such as heat, light, evaporation, or sterilisation can increase the risk of leaching.
- Certain routes of administration for the product. For instance, if the product is designed to bypass oral administration, it can carry a higher risk. Examples include inhalation or parenteral products.
Mitigation Planning
Following a risk assessment, our team will provide solution-focused recommendations and mitigating actions to help you prepare for regulatory submission.
- Extractable study – If the risk is deemed high enough, an extractable study may be recommended to further evaluate the risk, and determine if a leachable study is required.
- Leachable study – Upon review of the extractable study by a qualified toxicologist, a leachable study may be recommended to further quantify the risk.
- Sourcing alternative materials – If there are alternative materials available that do not contain the potential leachable, changing materials or suppliers may be a practical way to reduce the product’s risk profile. Our team can help to recommend alternative materials where possible.
- Supplier monitoring – Our team has extensive experience with implementing supplier monitoring programmes, and can provide advice to help further reduce the risks associated with material manufacturing processes.
Why choose Extractus?
We’ve been in your shoes! We have 45+ years combined experience in the pharmaceutical industry, working as E&L subject matter experts and outsourcing studies for some of the world’s largest pharmaceutical and consumer health companies. As such, we have a deep understanding of your needs, constraints, and regulatory requirements. We provide a fast, flexible, high quality, and solution-focused service to help you meet your targets on time, and within budget.