USP <789> Contamination Control Strategy for Ophthalmic Drug Products

To view on-demand, please fill our short form

*
Captcha verification required

Ophthalmic drug products face some of the most stringent regulatory expectations in the pharmaceutical industry. Standards such as USP <789>, which establishes tight particulate matter limits for ophthalmic drugs, underscores the critical importance of controlling even the smallest sources of contamination. The revision of EU GMP Annex 1 further emphasis this by requiring a comprehensive Contamination Control Strategy (CCS), pushing manufacturers to rethink how packaging components, sterilization processes, and system level controls work together to safeguard product quality.

This webinar focuses on how these regulatory expectations intersect with real-world challenges developers face when bringing an ophthalmic drug to market. Attendees will also learn how purpose built ophthalmic packaging components can help reduce risk and support regulatory compliance. Solutions engineered with low particulate profiles, no added free silicone oil, barrier film technologies, and ophthalmic specific design features offer advantages for improving dose accuracy, minimizing contamination, and supporting a robust CCS.

Listeners will gain insights into:

  • The importance of Contamination Control Strategies (CCS) for mitigating contamination risks in ophthalmic drug manufacturing
  • Key regulatory considerations for ophthalmic drug products, including USP <789> particulate limits
  • Common challenges developers encounter such as silicone oil concerns, particulate control, and endotoxin levels
  • Packaging and delivery solutions, designed to overcome the challenges associated with for ophthalmic drug development

Emily O Dwyer

Technical Account Specialist

Emily joined West in 2018 and currently is a Technical Customer Support Specialist supporting EU customers across all market units. In this role, Emily provides technical assistance and guidance related to West products, processes and services. She holds a Bachelor of Science Honours in Pharmaceutical Science.

Peter Cao

Senior Technical Account Specialist

Peter Cao is a Senior Technical Specialist on the Technical Customer Support team at West, supporting customers across North America with expert guidance on product selection and performance. Since joining West in August 2021, Peter has been instrumental in delivering technical insights related to component recommendations, as well as the company’s manufacturing processes that ensure the safety and quality of injectable pharmaceutical products. He brings over 10 years of experience in biomedical engineering and technical support, including a prior role at Siemens. Peter holds a bachelor’s degree from Penn State University, USA and a master’s degree from Drexel University, both in Biomedical Engineering.

Nisha Fernandes

Sr. Technical Account Specialist, TCS, NA

Nisha Fernandes is a member of the North American Technical Customer Support (TCS) team with West Pharmaceutical Services. Nisha partners with customers to provide product recommendations and technical support related to West and Daikyo packaging components and delivery system solutions. Prior to joining West, Nisha worked as a Sr. Project Manager at the Clinical Laboratory Standards Institute and as a Sr. Clinical Scientist in the Genomic Diagnostic Division of the Children’s Hospital of Philadelphia. She holds a Bachelor of Science in Biology, Master of Science in Genetics, and a Master of Business Administration.