Risk Assessment for Cyclosporine Eye Drops

• On the basis of above risk assessment, there is less risk with respect to cross contamination of product in sampling/dispensing area as only one material is being handled at a given time trained personnel and cleaning procedure after molecule change over is in place.
• As Risk involved in sampling& Dispensing room due to exposure of Cyclosporine in sampling/dispensing room is very less,i.e.,very less exposure time with respect to Cyclosporine exposure and proper gowning procedure in place to avoid any occupational health risk.
• Sampling /dispensing tools provided for handling of Cyclosporine’s products to avoid any risk of cross contamination of general molecule.
• During dispensing manufacturing operation of Cyclosporine’s products, all personnel having protective gowning including double gloves in hands, 3M Masks and safety goggles to avoid any exposure to product.
• In manufacturing area of Cyclosporine, Product manufacturing persons allowed to work only 4hours to reduce occupational exposure limit of Cyclosporine and person working inside the manufacturing area wearing Gloves, Goggles, Protective Clothing (PAPR snoods) and Filter Mask.
• Decontamination process of Area/Equipment &Rejected Drops Bottles shall be done using 2.5% Sodium Hypochlorite solution.

Training to be imparted to all concerned persons regarding proper gowning (PAPR snoods).