Sterile Ophthalmic & Nasal Spray Filling Operations
Highly experienced in aseptic filling of sterile ophthalmic solutions and nasal spray products ranging from 5 mL to 20 mL. Capable of manufacturing products using standard plastic bottle, stopper, and screw-cap assemblies, while also supporting advanced packaging configurations for preservative-free formulations utilizing specialized bottles and proprietary closure systems.
Demonstrated expertise in the setup, qualification, validation, and routine commercial manufacturing of sterile eye drops and nasal spray products, including snap-on closure technology for nasal spray presentations. Proven ability to manage complex filling operations while ensuring compliance with cGMP requirements, aseptic processing standards, container-closure integrity expectations, and regulatory guidelines.
Strong background in process optimization, technology transfer, equipment qualification, packaging compatibility assessment, and lifecycle management of sterile liquid dosage forms, delivering robust and compliant manufacturing solutions across a wide range of packaging formats.
