Protect your product from the packaging with the study of Extractables and Leachables, comply with international regulations and guarantee its quality and safety
Guarantee the safety and quality of your products
At Netpharmalab we are specialists in the study of Extractables and Leachables (E&L), a key process to ensure the quality of products in the pharmaceutical, biotechnology and cosmetic sectors. This study allows us to identify and quantify substances that can migrate from packaging, contact materials or processes to the final product, thus guaranteeing its safety throughout its shelf life.
What is the Extractables and Leachables study?
The Extractables and Leachables study aims to analyze the substances that can migrate from packaging materials to the product. These substances, known as extractables and leachables, can put consumer safety at risk, so this study is essential to:
- Comply with international regulations.
- Prevent contamination risks.
- Guarantee patient or consumer safety.
Applications of the study of Extractables and Leachables in different industries
- Pharmaceutical industry: ensures that packaging materials and delivery systems do not affect the safety or efficacy of the drug.
- Medical devices: protects the safety of the end user by preventing the migration of unwanted substances during the manufacturing process.
- Biotechnology industry: maintains the stability of sensitive biological products against possible contaminants.
- Cosmetics industry: prevents contamination of cosmetic products to preserve their purity and efficacy.
Benefits of the Extractables and Leachables study
By carrying out the Extractables and Leachables study with Netpharmalab, you will obtain:
- Regulatory compliance: it complies with the requirements of pharmacopoeias and international regulations such as the European Pharmacopoeia and the USP.
- Reduction of toxicological risk: it minimizes exposure to compounds harmful to consumer health.
- Optimization of the product life cycle: it ensures quality and safety from production to final consumption.
Our methodology for studying Extractables and Leachables
At Netpharmalab we apply advanced and internationally recognised methodologies, using analytical techniques such as:
- Chromatography and mass spectrometry (LCMS, GCMS, ICPMS).
- Comprehensive evaluation of extractables and leachables, including volatile and non-volatile organic components, as well as inorganic elements from packaging materials, administration systems and manufacturing processes.
- Toxicological risk analysis: carried out by expert toxicologists, members of AETOX, AEUROTOX and ERT, to assess the impact of each substance on the product.
- Study of leachables: allows us to identify and assess potential impurities in the final product, guaranteeing its safety throughout its useful life.
Why choose Netpharmalab
- Specialized technical team: we have a team of experts in this type of studies, with extensive experience in Quality Risk Management (QbD) and knowledge of the manufacturing process.
- Cutting-edge technology: we use the latest generation technology to obtain accurate results.
- Customized solutions: we adapt our studies to the specific needs of each client.
- Trust and experience: we work with leading companies in the pharmaceutical and cosmetic sectors, both nationally and internationally.
- Free advice: we offer personalized advice to define the best analysis strategy in accordance with current regulations.
Protecting your products from migratory substances not only ensures their safety, but also strengthens your position in the market. The study of Extractables and Leachables is essential to ensure regulatory compliance and avoid risks related to product quality.
Contact us today for more information and find out how we can help you ensure the safety and success of your products.
