The Romaco Macofar Oftalmica liquid filling machine meets all GMP requirements for processing pharmaceutical formulations with no added preservatives. The machine is fitted with an oRABS barrier system (either passive or active) and can be supplied with integrated laminar flow technology, if required.
The Oftalmica also is prepared for bio-decontamination with vaporized 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.
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. The Oftalmica has a maximum output of up to 12,000 bottles per hr, 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.
The Oftalmica processes a 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. For filling, the bottles are transported to the dosing station in clusters by a walking beam transfer system.
Two weighing systems ensure 100% weight control 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 utilized to fill nasal sprays or sterile injectables.
All the parts of the machine support plug-and-play removal and installation in a few simple steps. The format parts can be autoclaved, and, on request, the dosing pumps too can be cleaned fully automatically using a CIP (clean-in-place) or SIP (sterilize-in-place) system.