Sterile Ophthalmic Manufacturing
At Pillar5, our award-winning facility was purpose-built for the high-quality manufacturing of sterile ophthalmic solutions with trusted aseptic capabilities.
Partner with us to bring your next ophthalmic product to the North American market with high-speed compounding, filling, and packaging for eye drops, ear drops, and MDPF solutions.
With an annual capacity of over 40 million units and industry-leading capabilities in the filling of MDPF products, Pillar5 is your preferred partner for sterile ophthalmic manufacturing.
Aseptic production of sterile ophthalmic solutions for the OTC market in North America.
Our Sterile Ophthalmic Manufacturing Capabilities
At Pillar5, we are a leading manufacturer of sterile-preserved ophthalmic products for consumer health markets in North America. Our solutions are filled in standard 3-piece devices, supplying the U.S. (90%) and Canada (10%). We have shipped to over 35 countries historically.
We are proud to be the first CDMO in North America to offer commercial multi-dose preservative-free (MDPF) filling services for sterile ophthalmic solutions. Learn more about our MDPF capabilities here.
Our aseptic capabilities support pharmaceutical drug development, including processing, compounding, filling, and packaging.
Our aseptic processing areas include:
- Compounding Area — Class C Environment
- Aseptic Prep Area – Class B Environment
- Filling Area — Class A Environment
In 2019, our facility’s annual aseptic capacity increased by 100%, from 20 to 40 million units, with the start-up of new high-speed filling and packaging lines. We plan to add the capacity for at least million units of capacity by 2024.
Sterile Ophthalmic Solution Compounding
Our facility provides ophthalmic compounding for a large range of batch sizes, from small 100L batches up to 8,000L batches.
We will also provide compounding for non-GMP lab trials in batches between 10 and 40L. Contact our team for more information on non-GMP lab trials.
Sterile Ophthalmic Filling
Our facility features two high-speed aseptic filling lines, with Grade A enclosures to meet sterility requirements. Our lines are set up to fill devices across a range of containers, from 6ml to 30ml. We operate at rates of 100 bpm to 250 bpm and with a capacity of 70,000 bottles per shift.
In addition to standard 3-piece devices, we have the ability to fill devices with 2-piece closure systems (i.e. dropper tip & cap) or single-piece press fits or screw caps, depending on the requirements of your product. We also have the capability to fill multi-dose preservative free (MDPF) devices.
Our lines are equipped with a vision system to monitor all critical aspects of filling. Bottles are filled into brightstock to await environmental results prior to final packaging.
Sterile Ophthalmic Packaging
Our pharmaceutical packaging capabilities include automated bottle and blister packaging lines. Our facility features two high-speed packaging lines with the capability to label and package bottles at rates of 200+ bpm with a capacity of 70,000 bottles per shift.
Devices can be packaged in either individual cartons or individual card-backed blisters, depending on the requirements of your product. Many flexible packaging options are available, including tamper-proof packaging.
Partner with our team to manufacture sterile ophthalmic products.
