Package for a pharmaceutical product and method of manufacturing and sterilizing the package

A method of manufacturing and sterilizing a pharmaceutical package wherein the package comprises a lower base portion having a cavity for containing the pharmaceutical product and a flange extending outwardly about the periphery of the cavity, the cavity being defined by a bottom surface and side wall surfaces, extending between the bottom surface and the flange, and a flexible cover sheet welded to the flange, a calibrated orifice in the bottom surface which is covered by a second cover member releasably sealed to the bottom surface around the perimeter of the orifice, the method comprising the steps:

• a) preparing a plastic lower film material for the lower base portion and a plastic film material for the upper film material for the cover member by locating an intermediate film between the two layers formed by the lower and upper film material for the following steam sterilization in an autoclaving chamber;
• b) sterilizing the packaged film material in the autoclaving chamber by a temperature of 121° C. during 20 minutes;
• c) preheating the lower film material by progressively heating in three steps from 20° C. to about 150° C. between two hot-plates at each preheating station;
• d) thermoforming the lower base portion by using dies and molds with a specific temperature for the dies and molds and by regulating the temperature, the pressure and the time by computer-control;
• e) piercing a calibrated orifice through the bottom surface for delivering the product at the moment of use by a customer;
• f) closing the orifice by the second cover member which is sterilized by gamma-radiation or steam;
• g) filling the cavity of the lower base portion from the top with the pharmaceutical product;
• and
• h) welding the upper film onto the flange.