_________________________________________________________________________________________

Lyophilizer Loading / Unloading

Present technologies in use to load and unload vials in a lyophilizer, can vary from manual to completely automated. Manual loading is typical of a lab or pilot plant lyophilizer units where the quantity of vials are smaller and easier to handle. Trays of vials would be placed on the shelves, one at a time, and pushed into position loading from back to the front of each shelf. This would require tools to be able to push and retrieve the trays during loading and unloading. The loading and unloading areas of the Lyophilizer must also be in a laminar flow Class 100 area.

However, manually loading larger pilot scale to production sized units, the lyophilizer loading and unloading of thousands of glass vials would become much more time consuming, strenuous, and typically utilizes some additional equipment such as accumulator tables, tray loaders for arranging vials onto a tray which will assist the operator in properly configuring vials

into trays and manual loading and unloading them. Vial positioning on trays can be crucial to some Lyophilization processes and tray loaders provide a repeatable vial orientation on the trays for each vial size used. Whether vials trays are bottomless or have bottoms or are constructed of stainless steel or plastic, is a process related issue and should be evaluated from a material handling concern as well as a heat transfer concern. Plastic trays do not significantly

impede heat transfer between the cooled shelves and the glass vial; however, they are flimsy and may not be able to firmly support some of the larger vial sizes satisfactorily.

   Bottomless vial trays are best for processing product contained in vials as they allow for the vials to sit directly on the shelf, for the most efficient heat transfer between shelf and product. The trend in processing liquid products in vials is towards use of the bottomless trays or fences, as they are also referred to as. Fences sit on the shoulder of the vials and keep the vials in a tight

pack for sliding onto and off of the chamber shelves. The type of tray to be used should be evaluated along with other scaleup considerations when developing the process.