All customers' products will be loaded into galvanized/stainless steel totes (with internal dimension of 60cm x 90cm x 140cm) at the loading Ė unloading station, then using a forklift the totes will be placed onto the carriers. Each carrier contains two vertically positioned totes. The maximum loading capacity of the carrier is 544 kgs of product. The product carries pass through the cell at a defined cycle time with a constant conveyor speed of 7 meters per minute.
The Typical minimum dosage for medical devices is 25 kiloGrays (kGys), with a range accorded by the productís material compatibility and the package density of the product. This range will be determined and confirmed during the validation process. Doses less than 25 kGys may be achieved by mechanically decreasing the carrier dwell time or altering the productís flow through the cell. Very low doses (such doses may be required for foods), but which also require a high level of uniformity, are achieved by employing only one level of the carrier (the lower tote) and decreasing the cycle dwell time.
Gamma irradiation processsing has been widely used in over 45 countries. The operation of our gamma facility is relatively simple because the complexity of the process has been incorporated into the design of our equipment. Product are loaded into insulated metal boxes, called totes, which are then automatically transfered into two or three tiered products carriers for processing. Typically, each tote makes two or three passes through the irradiation cell, once at each vertical level of the product carriers. This results in excellent dose uniformity, and thus overall sterility.
This vertical transfer of the totes from level to level is completely automated and takes place outside the irradiation processing chamber. Both the transfer of the totes and the movement of the product carriers are directed by programmable logic controller fo maximum reliability.