Сòòò½APP

Сòòò½APP offers an extended range of extractables and leachables training services covering the use of materials in packaging and medical applications to keep you up-to-date with the ever-changing regulations.

The guidelines for pharmaceutical packaging, manufacturing equipment and medical devices are continually progressing. Knowledge of the composition of these components at a very early stage in process development is essential to determine their leachable risk. 

Our Extractables and Leachables (E&L) training services provide you with a thorough understanding of the supply chain for materials and enable you to evaluate any potential risk to your products when dealing with vendor imposed material changes.

Extractables and leachables training programs

From regulatory compliance to routine E&L testing in quality control, Сòòò½APP’s training programs can address all relevant aspects in the industry. The goal of our training programs is to create a company-wide understanding of the regulatory expectations for extractables and leachables testing. 

As part of our training courses, our Engaged Experts share their in-depth experience in developing a strategy for the control and management of leachables from the materials used in packaging, medical devices, and single-use processing system.

Topics of our extractables and leachables training courses

• Overview of E&L
• Review of the materials typically used in packaging and manufacturing equipment
• Key factors that impact the leaching of chemicals from polymer substrates
• Regulatory expectations for E&L testing
• Container Closure Systems (CCS)
• Single-Use Processing Equipment
• Medical Devices – ISO 10993
• The new suite of USP <661> testing along with <1663> and <1664>
• Industry recognized “best practices” for performing E&L testing
• Efficiently dealing with unexpected material changes
• Implementing quality control measures to evaluate new batches of CCS components and single-use processing equipment
• Partnering with vendors to manage the supply chain

In addition to these standard courses, our Engaged Experts can design customized training programs to meet your specific needs. The workshops include a combination of in-house lectures and real-time on-site consulting to better address your specific training needs.

For more information about our extractables and leachables training services or to request a quote, contact us today.