Filtration for ophthalmic formulations
Ophthalmic solutions filtration plays a vital role in producing eye drops, lens-care fluids, and therapeutic rinses, some of the most delicate sterile pharmaceuticals. Because every drop comes into direct contact with the eye, there is zero tolerance for contamination or inconsistency. Any loss of sterility or change in formulation stability can directly affect patient safety, making sterile liquid filtration an essential safeguard throughout production.
Each stage in eye drop manufacturing plays a precise role in maintaining purity and stability. Prefilters remove particles and bioburden before compounding, while sterilizing-grade filters provide microbial protection during filling. Vent filters protect storage tanks during air exchange, maintaining aseptic conditions from formulation to packaging. Together, these steps preserve clarity, ensure consistency, and stabilize preservative levels.
Atlas Copco filtration solutions are engineered from validated, high-quality materials that meet ISO 9001, FDA CFR Title 21, and EU 1935/2004 standards. Each filter provides reliable, low-binding performance that helps minimize preservative loss, maintain flow rates, and support GMP sterile processing. This ensures every batch meets the highest standards of quality, safety, and regulatory compliance.
The process map below illustrates how filtration supports every phase, from prefiltration and bioburden reduction to sterilizing-grade barriers and final filling, demonstrating how each safeguard protects both the product and the patient.
Filtration solutions for ophthalmic systems
Atlas Copco provides specialized filtration that safeguards sensitive formulations, ensuring clarity and long-term stability in eye drops and eye wash production. Our solutions include:
- SMT-G PTFE filters:
Installed on tank vents to protect against microbial ingress during air exchange, ensuring product integrity throughout formulation and storage. - PFP-A⁺ PP filters and BME⁺ PES filters:
Used together for pre-filtration and bioburden reduction, removing larger contaminants early and protecting downstream sterilizing-grade membranes to ensure consistent quality.
SME⁺ PES filters:
Sterilizing-grade membranes that secure sterility of ophthalmic solutions, preserving sensitive formulations without impeding flow. - SMV PVDF filters:
Low protein binding, sterilizing-grade membranes that help preserve sensitive ingredients such as preservatives in lens care and prescription drops, maintaining clarity and stability.
Together, these filters ensure that ophthalmic products remain sterile, stable, and safe for patient use, while supporting regulatory compliance in critical fill-and-finish operations.
Key filtration benefits in ophthalmic systems
Benefits for manufacturers
Frequently asked questions
Why is ophthalmic filtration more challenging than other pharmaceutical products?
Eye drops and lens care solutions often contain preservatives like BAK or parabens, which can adsorb to membranes. Filtration must provide sterility while minimizing preservative loss.
Which membranes are typically used for ophthalmic systems?
PES membranes are widely chosen for low protein binding and high flow; PVDF is used when very low adsorption of preservatives is required.
How do you ensure preservative concentration stays in spec after filtration?
By selecting low-binding membranes, validating adsorption profiles, and monitoring preservative levels during process validation.
Do ophthalmic solutions need sterilizing-grade filters?
Yes. Ophthalmic solutions are sterile drug products and require 0.22 µm sterilizing-grade validated filters for microbial retention.
Why use a process map in ophthalmic filtration?
Because filtration is applied multiple times: prefiltration of excipients, sterilization of bulk solution, and sterile venting of tanks/fill lines. The map clarifies how sterility is safeguarded at each step.
