The ophthalmic solution preparation system mainly includes concentrated preparation tanks, dilute preparation tanks, process pipelines, valves, sterilizing filtration systems, in-line cleaning (CIP), in-line sterilization (SIP), etc. Since ophthalmic medications are used in the human eye, the requirements for asepsis or sterilization are extremely high, and must meet GMP standards. The sterilizing filtration system requires primary filtration with a 1.0 μm filter, followed by 0.45 μm and 0.22 μm filters.
The ophthalmic solution preparation system can be designed with manual control and touchscreen PLC automatic control. Different control systems are designed according to various process requirements. The fully automatic control system allows parameter setting, reading of process parameters from equipment, storage and simulation of data curves, printing, as well as password and permission settings.
The system can be designed with a distribution function to closely coordinate with the filling machine, enabling automated control and switching. In-line cleaning (CIP) and in-line sterilization (SIP) are designed according to both manual and automatic processes. The PLC touchscreen allows manual control of the operation program. Once the program runs, the PLC control system manages CIP or SIP. In case of automatic control program failure, manual reset operations can be performed for the automatic control part, and CIP or SIP can be carried out manually.
For the concentrated preparation tanks, dilute preparation tanks, and supporting sterilizing filters, valves, pipelines, and detection devices in the system, CIP and SIP form a complete system. The operation procedures are designed for segmented cleaning (CIP) and segmented sterilization (SIP). For example, the cleaning (CIP) and sterilization (SIP) of sterilizing filters, pipelines, valves, etc., from the concentrated preparation tank to the dilute preparation tank, and the cleaning (CIP) and sterilization (SIP) of sterilizing filters, pipelines, valves, etc., from the dilute preparation tank to the buffer tank or filling machine can be carried out separately.
