In recent years, biopharmaceutical developers have rapidly adopted single-use systems to improve operational efficiency, enhance product quality and consistency, and reduce costs. As demand for these systems grows, the importance of uninterrupted supply and high-quality materials have become critical factors when selecting technologies and services.
We recognize the critical role we play in your daily operations and the need for business continuity. As your supplier, we’re continuously investing in capacity, quality, and people to support your evolving needs to safely and efficiently develop new and novel therapies.
Our team is dedicated to continuous improvement to meet those needs by:
Particulate control in the design and manufacturing of single-use solutions is essential for ensuring the safety and efficacy of groundbreaking therapies. As an innovative leader in single-use solutions, Charter Medical follows stringent processes and procedures to ensure the highest levels of particulate control. In addition to operating in ISO 7- & 8-certified cleanrooms and following gowning procedures that comply with ISO 5 standards, Charter Medical’s rigorous environmental monitoring programs and strict inspection processes are designed to minimize the potential for particulate contamination within our single-use solutions. (Learn more about our particulate control practices.)
At Charter Medical, we’re committed to patient safety, just like our customers. Leveraging our polymer expertise, we work alongside biopharma manufacturers to not only help them select standard products but also fine-tune custom solutions using the right materials of construction for process integration. This includes offering material options that are free of harmful additives such as DEHP. (Learn more about how DEHP can impact advanced therapies.)
Supply chain reliability is pivotal to the success of biopharmaceutical manufacturing. As your single-use supply partner, Charter continues to increase manufacturing capacity with additional cleanrooms and streamlines production processes to shorten lead times. We also enforce stringent raw material sourcing and inspection programs to safeguard against supply chain disruptions and other challenges. (Learn more about how a robust single-use supply chain can benefit your end product.)
Your trust in us is paramount, and we sustain it by adhering to the highest regulatory standards in the industry. As an ISO 13485/NSAI-certified and FDA-registered company, Charter Medical maintains compliance with quality and regulatory requirements in everything we do. In August 2023, Charter completed an FDA audit with zero documented findings. Our robust quality systems ensure you receive reliable, high-quality products for your process development and commercialization needs.
Learn more about our solutions designed to address your needs.
