Corning – Media – Custom Media and Serum

Quality

A System That Ensures Success

Our custom media and serum products follow strict production procedures, and are required to meet high purity and production consistency standards in order to deliver the highest-quality media products. We offer exceptional quality and traceability, including:

• ISO certification: Certified to ISO 13485, which meets requirements related to device design, manufacturing process, supplier management, traceability, and record retention.
• Quality testing: To ensure we meet stringent release criteria, our finished products are tested by industry standards using USP or EP monographs as applicable to ensure they meet functional, biological, and physicochemical requirements.
• Sterility Assurance Level: All Corning® media products meet the sterility assurance level of 10^-3, and we constantly seek to provide a sterility assurance that is as low as is reasonably possible.

Manufacturing

Manufacturing Capabilities

Our manufacturing facilities are committed to delivering high quality, customized products designed to your specifications with:

• Rapid set-up times
• On-time delivery
• Continuity of supply
• Consistent product performance
• Reproducible processes

Our custom manufacturing capabilities include:

• Separate designated rooms for animal and non-animal products
• Manufacturing within environmentally controlled spaces
• Formulation and dispensing to requested volume specifications, hand-fill, semi-automated, and automated filling

Component Option

Customizable Components

• USP, EP, and/or JP compendial
• Formulation
• Raw materials
• Unit size and fill
• Powder or liquid
• Animal or non-animal
• Packaging (bags, bottles, shipping packing, kitting)
• Labeling
• Intended use statement, within regulatory guidelines

Key Features

• High-Quality Standards: Manufactured under ISO 13485 certification and FDA Quality System Regulation 21 CFR 820, ensuring compliance with current good manufacturing practices (cGMP) and FDA requirements for manufacturing and sterility.
• Rigorous Quality Testing: Finished products undergo stringent testing using USP or EP monographs to meet functional, biological, and physicochemical standards, ensuring high purity and production consistency.
• Customizable Components: Offers flexibility in formulation, raw materials, unit size and fill, powder or liquid form, animal or non-animal origin, packaging options (bags, bottles, shipping packing, kitting), labeling, and intended use statements within regulatory guidelines.
• Advanced Manufacturing Capabilities: Facilities include separate designated rooms for animal and non-animal products, environmentally controlled spaces, and various filling methods (hand-fill, semi-automated, and automated) to meet specific volume specifications.
• Comprehensive Support: Provides a full range of services to meet custom media formulation, packaging, and regulatory requirements, backed by extensive experience and expertise to support diverse research needs.