Filling of sterile eye drops
Oftalmica liquid filling machine for sterile ophthalmic productsRomaco Macofar’s Oftalmica was specially developed for aseptic filling of sterile eye drops, nasal sprays and injectables. Meeting all GMP requirements for safe processing of highly viscous, oily and foaming liquids, the machine additionally offers fast format changes and short cleaning times.
The Oftalmica is Romaco Macofar’s latest technology for aseptic filling of sterile eye drops. This newly launched liquid filling machine is the pharmaceutical machinery manufacturer’s answer to the growing demand for ophthalmic products with no added preservatives. Much stricter GMP regulations apply when these modern pharmaceutical formulations have to be filled under sterile conditions, and the Oftalmica fulfils them all – especially where the sterility assurance level is concerned. The machine is therefore fitted with an oRABS barrier system (either passive or active) and can also be supplied with integrated laminar flow technology if required. The Oftalmica is moreover prepared for bio-decontamination with vaporised hydrogen peroxide (VHP). Glove ports provide full access to all critical components without having to open the doors of the liquid filling machine, meaning the permissible SAL values for cleanroom class A are reliably maintained inside the machine. This facilitates process validation and production can be resumed more quickly.
Easy handling of highly viscous, oily and foaming liquids
The Oftalmica is used to fill all kinds of liquids, including highly viscous, oily or foaming fluids. The machine can be equipped for this purpose with up to eight separately driven rotary piston pumps made of ceramic or stainless steel, which can be individually controlled on the HMI. The Oftalmica’s dosing station also enables a two-phase filling process to achieve a constant, high filling capacity while at the same time reducing the load on the pumps. This approach is especially recommended for products with poor flow properties. In addition, filling in two steps Page 2 of 4 has proved successful for bottles with very small necks, because ultra-fine filling needles with a correspondingly lower flow rate are used here. The same applies when filling foaming products whose flow rate is limited solely by their physical properties. Thanks to the two-phase filling technology, the Oftalmica by Romaco Macofar has a maximum output of up to 12,000 bottles per hour – regardless of the specifications of the liquids being filled or the dimensions of the containers. If required, the Oftalmica can also be supplied with peristaltic pumps.
