IRISYS’ New Capability for Sterile Ophthalmic Clinical and Commercial Manufacturing
IRISYS is pleased to announce that our sterile fill capability has been expanded to include ophthalmic drug products. Our new state of the art Ophthalmological manufacturing equipment meets quality control standards that include a sterile environment, chemistry monitoring, water quality standardization, and environment monitoring all while using IRISYS new fully sterile dropper bottle filling machinery.
The Ophthalmic Manufacturing Process
The process to complete a fully sterile ophthalmic drug begins with sterile water, an important component in the ophthalmic manufacturing process. Once completely purified, the water is piped through airtight aseptic tubes to assure that no impurities can contaminate the water and jeopardize its sterile nature.
Next, the water is mixed with the pharmaceutical grade raw materials that have been tested for ID potency and bioburden. Although the measuring process is computer controlled, the entire process is being overseen by IRISYS scientists.
Once the solution has passed in-process Quality Control Testing, it passes through redundant sterilizing filters into sterile eye dropper bottles. This step in the process is completed by a fully automatic filling machine without any human contact. The machine then inserts dropper tips, the bottles are capped and labels automatically applied. It is at this point that serialization can take place. Full aggregation from bottle to shipper to pallet is available for small and large batches.
Throughout the ophthalmic manufacturing process testing is performed for:
Absence of Microbiological Contamination
Physical and Chemical Characteristics
Adequacy of Environment Conditions (Environmental monitoring)
Once the bottles are filled and packaged and quality control tests have been completed to ensure the finished product meets all specifications, Quality Assurance reviews and approves all documentation and the drugs are sent out to the clinical sites for human testing or distribution centers for commercial distribution.
“IRISYS’ high level of attention to detail is why so many of our clients are repeat clients and why our products are known for exceeding industry standards.”