Studying the impact of extractable and leachable substances on safety and drug product interaction is of utmost importance to protect the patient and comply with regulations.
Leachable materials may originate from pharmaceutical container closure systems, process equipment, and medical device packaging, and migrate to contaminate products. Extractables and leachables (E/L) studies identify and quantify these substances, ensuring the quality and effectiveness of the drug product. A full-service extractables and leachables testing program also helps you to fulfil the regulatory requirements of your pharmaceuticals and medical devices.
Our extractables and leachables services include:
- Material selection for pharmaceutical container closure systems (CCS) and medical devices
- Customized E/L study designs developed according to the latest industry best practices
- Complete method development and validation programs
- Toxicological safety assessments
- Development of E/L materials risk assessments and strategy documents suitable for regulatory submission
- Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12, and 17
- On-site training and consulting programs.
We perform extractables and leachables testing on:
- Container closure systems (CCS), including combination products
- Single-use manufacturing equipment, including BPOG protocol
- Implantable medical devices
- Drug delivery and infusion systems
Exova’s laboratory complies with Good Manufacturing Practice (cGMP) guidelines. Our scientists have been active participants in the working groups that have developed the current extractable and leachable best practices such as PQRI, USP Expert Panels, ELSIE, and BPOG.
Our experience, advanced equipment, and in-depth knowledge of materials and the regulations result in the efficient and successful completion of E/L testing programs for pharmaceutical packaging and manufacturing equipment as well as medical devices.
Mike Shelton - Technical Director
Specialism - Analytical development and validation of trace impurity quantitation and novel entity assay methods, in particular using hyphenated mass spectroscopy techniques.
Qualifications - BSc Chemistry, 1982, University of California, Irvine (ACS qualified program)
Extensive experience in developing and validating analytical methods in support of the characterization of pharmaceutical, biological, and consumer product materials, including developing analytical approaches for degradation products, extractables, and leachables from medical devices. Expert in California Proposition 65 compliance and environmental regulations. Radiation Safety and Chemical Hygiene Officer for the laboratory.
Development and publication of novel methods in unique matrices for the determination of impurities, such as 1,4-dioxane in personal care products, perchlorate in drinking water and foods, nicotine degradation compounds in smoking cessation products, and Polysorbate in buffered protein solutions.
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1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204