Loading and unloading systems

The increasing demands made in recent years by national and international health and regulatory authorities with respect to sterilization and safety against contamination require a rethinking of freeze-drying processes. 

The loading and the unloading storage are served by the battery-driven transfer cart (in the background). (Novartis, Stein/Basel, Switzerland). 

Another concept is the automatic loading and unloading system for freeze-drying chambers that have been designed as push-through chambers. In such cases, the sterile loading side (unprocessed product) is separated from the sterile unloading side (freeze-dried product). 

Materials used must cleaned and disinfected with the usual cleaning and disinfecting agents. Friction in the transport system must not cause particles. Electric motors without ventilators must be used and the sensors installed must be resistant to the cleaning and disinfecting agents. In general, every process must be reproducible, documented and validated. 

vial level/transfer table 4, drive for transfer 

Therefore, it is decisive for the freeze drying process which follows that the filled vials during this time pass through a known and reproducible course of temperature. The prod- 

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Solutions loading and unloading system, heat exchanger and all other wet parts are manufactured from materials that are suitable for use with aggressive fluoride liquids. 

Fig. 1.68. Temperature distribution during freezing (4.5 h) and freeze drying (8 h) Each shelf carries a frame for radiation shielding. The design can be different, depending on the kind of vials and the loading and unloading system.

Fig. 2.51.2. The completely in isolators enclosed transport-and loading and unloading system.

Fig. 2.51.3. The loading and unloading system inside the isolators in front of the freeze drying plant (Fig. 2.50.1-2.50.3, AMSCO Finn-Aqua, D-50354 Hiirth).

The installations have been taken over from the seller at (date and time). Before the take-over, the seller has successfully corrected complaints listed in appendix 1 of the takeover protocol. The freezing and freeze drying plant is registered as GF 50/95/1 and the loading and unloading system as GF 50/95/2. 

Fig. 2,51,1, Schema of a loading and unloading system for two freeze drying plants.

Different demands made on production processes, the local conditions and the desired degree of automation lead to different solutions. Industry offers proven concepts that can be validated, e.g. a concept in which trays filled with bulk product or vials are introduced into a drying chamber semi- or fully automatically. However, loading and unloading systems that operate without trays are preferred the vials are loaded into the drying chamber or chambers fully automatically from the filling machine, as shown in Figures 2.73.1 and 2.73.2. 

The push and pull system has proved useful for automatic loading and unloading systems which operate under an isolator (Figure 2.74.1). Such systems are also available as AGV systems. 

It must be possible to adapt the loading and unloading system to the filling speed of the filling line and to the speed of the capping machine. 

Isolator technology is required especially when processing toxic or anti-cancer products and where the operator and his environment must be protected. An automatic loading and unloading system installed in an isolator system can be CIP cleaned and can be sterilized with vaporized hydrogen peroxide (VHP) (Figure 2.74.1). 

Fig. 2.74.1. Automatic loading and unloading system (ALUS), completely enclosed in isolators, for vial transportation. (Steris GmbH, D-50354 Hiirth, Germany).

J. W. Mason, Design Aspects of Loading and Unloading Systems Which Can Mitigate or Eliminate Accidental Chlorine Releases. In R. W. Curry (ed.). Modem Chlor-Alkali Technology, vol. 6, Royal Society of Chemistry, Cambridge (1995), p. 48. 

Figure 22 Example of a SCADA (Supervision, Control, and Data Acquisition) solution for several freeze-dryers (1,2,. ..,X), one loading and unloading system (ALUS), built into an isolator. Furthermore, a CIP (Clean in Place) system is controlled and monitored, (Steris GmbH, D-50354 Hurth, Germany).

If, for example three sensors are placed at three different places in the product, depending on the location of the sensors, different temperature values will be indicated (Figure 14.5). In addition, in a production freeze-dryer - for practical reasons - the product temperature can only be measured in a few vials or product trays. In freeze-dryers with an automatic loading and unloading system, the use of temperature sensors is not possible at all. 

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