Outstanding technical details on turnkey filling and packing lines, isolators with considerably shorter sterilization cycle times, freeze dryers, flexible and compact machines as well as equipment for diagnostics will be presented by Optima Pharma at Achema in Frankfurt am Main, from 18 to 22 July 2012, in hall 3.0, booth A73.
A complete Optima line for vials encompasses all process steps from unpacking to tray loading of processed vials. Isolators and the freeze drying process are also components of the line. A 100% IPC and the stopper re-setting process maximize product usage. The M+P isolator uses H2O2 to sterilize the machine cabin and operates at an ISO 5 environment. With the use of catalytic aeration, considerably shorter sterilization cycle times can be achieved. Vials are transferred via a turntable to one of 6 Klee freeze dryers to achieve the most flexible loading configurations. A combination crimp cap and coding machine, final tray loading and numerous inspections complete the Optima equipment.
A total of 5 projects have been prepared in a 3D box. First on the tour is a specially designed line for fully automatic high speed filling and stoppering of sensitive biopharmaceutical gels into ready-to-fill syringes. Even the entire HVAC for the customers’ production rooms was designed and delivered by Optima. Another vials processing machine – here in the mid output range: Ionization, IPC, and nitrogen gassing for reducing the oxygen content and optical monitoring are all integrated. Filling and packing of diagnostic products: A Kugler Linoline fills 12 cavities of a diagnostics cartridge. Twelve servo driven peristaltic pumps dose 12 different liquids with 12 different volumes. These projects, as well as a Klee freeze drying unit and an automated loading and unloading system, will be presented to you in the 3D Box.
Tangible machines at Achema include the Inova SV125 in modular construction. This machine counts as being extremely compact and flexible. Equipped with isolator technology, the highest levels of sterility are achieved. The SV125 can be made to process both pre-sterilized nested syringes, as well as nested vials. A selection of filling systems and tertiary equipment such as an automated de-bagger or Tyvek removal for full line automation are available.
The Kugler Linoline is a machine platform also specially suited to covering a large range of formats. The Linoline presented at Achema is capable of dosing small volumes (1 mL) right up to 1000mL. Typical bottle diameters range from 16mm up to a maximum of 95mm. The design allows for filling of 2-stage component products; allowances are made for the installation of additional weigh cells. Further features include pre-torquing, final torquing with an integrated torque monitoring system and an even faster format change at the capping station.
Klee is showing its freeze dryer pilot plant which was originally designed for performing freeze drying trials, with the capability of being reconfigured for production purposes. The design allows manual loading and unloading under an isolator. The freeze drying chamber can be VHP sterilized. A special device at the rear of the machine allows the stoppers on individual vials to be pressed in during the process to monitor progression of lyophilization at different stages during a test batch.
The M+P lab isolator allows weighing and formulation of products to take place in a protected environment. The access doors are pneumatically sealed. Four integrated gloves give operators access to the pressure controlled zones. Adapter ports ensure compatibility to different port mechanisms.
The Medicon ImmuCoat unit on display at Achema, will be fully functional. The modular and scaleable system consists of different units for fully automated coating of microtitre plates. The base station modules can be individually configured with dosing and washing modules and complemented with different print and monitoring systems. Additionally, a fully climatized incubator / drying module and final packing module are on display. The output is up to 1,200 plates per hour.