Method and apparatus for preparing syringes containing a lyophile medicine

Process for simultaneously preparing a series of auto-injectable syringes containing a lyophile medicine, the syringes being of the type having a tubular body with an open upper end, and a lower end adapted to receive an injection needle, and an elongated plunger having a piston at its lower end which is insertable through the open upper end and frictionally slidable in the tubular body, said method comprising the steps of:

• sealing the lower ends of a number of tubular syringe bodies with a removable seal;
• positioning the syringe bodies vertically on a first flat horizontal rack so that the tubular bodies pass through holes of the first rack, and are held in the rack with their upper ends at the same level;
• filling a predetermined quantity of a solution of the medicine into each tubular body through the open upper end of the body;
• placing the same number of plungers in a second rack by introducing the piston ends of the plungers into holes of the second rack of a size to retain the pistons by friction;
• positioning the second rack retaining the plungers on the first rack holding the syringe bodies to form an assembly in which the holes of the second rack are coaxially aligned with the holes of the first rack and the piston ends of the plungers face toward and are axially aligned with but spaced above the upper ends of the syringe bodies so the upper ends of the syringe bodies are open;
• placing the assembly in a lyophilizer apparatus;
• performing lyophilization on the medicine in the syringes within the lyophilizer apparatus;
• then establishing a pressure lower than atmospheric pressure in the lyophilizer apparatus;
• then simultaneously forcing the plungers downwardly into the syringe bodies to move the pistons to a predetermined position in the bodies, above the lyophile medicine;
• then increasing the pressure in the lyophilizer to atmospheric pressure;
• and
• then removing the medicine-containing syringes from the lyophilizer, and from the racks, without removing the plungers from the pistons;
• said second rack comprising a plurality of disengageable cross-members being held in an operative position against each other by a removable clamp, said cross-members having vertical side wall along the length thereof with said vertical side walls having at spaced intervals half-holes formed therein whereby, when two of said cross-members are placed in juxtaposition, said half-holes, respectively, thereof, will face each other to define said holes of said second rack, said process further including the step of, after lyophilization, removing said medicine-containing syringes by sequentially removing said cross-members one-by-one.