Optima Group Pharma at Achema 2009

Turn-key line competence is one of the most impressive features of the vial line which was shown at Achema. This comprises of both Inova and Klee components: Line functions include cleaning, sterilizing, filling, freeze drying and closing – with process controls. Klee was at the fair also with a pilot freeze dryer for lyophilized bio pharmaceuticals, operable under isolator even when manually loaded.

Monoblock Machine

Kugler Linoline, a monoblock machine, proved optimum flexibility, not only with regard to filling quantities but also to closure types. The rotary piston pump version covers a format range from 0.2 to 1,000 ml. With eight filling positions, the machine achieves a maximum output of 100 bottles per minute for formats of less than 100 ml. The system is complemented by a 100% in-process control. The closure systems of the monoblock machine - installed as successive closing stations - can process plugs, inserts, plastic or metal screw caps with or without safety features, PP closures, spray dispensers and caps. The machine, equipped with full servo gear, supports fast format changes, enabled by format parts of broad application ranges, and quick-change tool systems. A PC is the central control unit.

Klee Freeze Dryer

The Klee freeze dryer which was presented at Achema is a pilot machine, normally used for freeze drying tests. If required however, the machine can be modified for production. This special design of its slide door allows manual loading and unloading under the isolator. The door can also be swivelled away to allow for cleaning access. VHP sterilization of the freeze dryer is possible. A special plug closing mechanism at the rear of the machine allows individual vials of a testing lot to be closed, enabling the user to evaluate ongoing processes. The line has been designed for ATEX operation, but can also be run conventionally. With three surfaces available for setup, the machine footprint is 0.6m². 2R to 200H vials can be processed. Productivity per lot ranges between 207 and 2,469 vials. The use of a pilot line alleviates any interruption during the regular production process for freeze drying experiments.

Sterile API Transfer System

The SteriCon^® transfer system by Lugaia for sterile APIs and materials is a safe and extremely inexpensive solution. The system uses laminated and pre-sterilizable foil products that are manufactured in an ISO class 5 clean room. It comprises, on the one hand, a bag filled with sterile pharmaceuticals, containers or closing materials etc., which are fed into or fed out of the isolator, and on the other hand, an endless poly tube as the transfer connection.