New liquid filling machine for sterile ophthalmic products
Oftalmica by Romaco Macofar
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 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.
Ideal for many different products, containers and closures
The Oftalmica processes a vast range of plastic and glass bottles with a filling volume of between 1 and 30 ml and can be used to apply any standard closure system. Depending on the type of closure, the machine can be configured with up to three closing stations. The lightweight plastic bottles are held on the belt by vacuum as they travel through the machine, which leads to optimal process stability. For filling, the bottles are transported to the dosing station in clusters by a walking beam transfer system. Two weighing systems ensure one hundred percent weight control both before and after filling. The empty and full bottles can be inerted on request for oxygen-sensitive products. As an option, the Oftalmica can also be utilised to fill nasal sprays or sterile injectables.
Fast product changes, short cleaning times
Overall, the Oftalmica offers numerous advantages whenever frequent product changes are common. To reduce the time for retooling, the formats were designed for a wide range of container sizes. All parts additionally support plug & play removal and installation in a few simple steps. What’s more these handy format parts can be autoclaved, which makes them easy to clean. On request, the dosing pumps too can be cleaned fully automatically using a CIP (cleaning in place) or SIP (sterilisation in place) system. GMP-compliant, easy to operate and high performing – these are the hallmarks of the new Oftalmica liquid filling machine by Romaco Macofar.