Apparatus for and method of manufacturing a prefilled sterile container

An apparatus for continuous in-line production of a plurality of sterilized, prefilled containers comprising:

• a sterilization station comprising a means for continuously sterilizing a plurality of containers;
• a sterile isolator comprising an opening for continuously receiving a plurality of containers;
• a sterile ambient atmospheric condition adjacent the opening;
• a transport mechanism for continuously transferring a plurality of sterilized containers from the sterilizing station to the sterile isolator wherein the plurality of sterilized containers are exposed to the sterile ambient atmospheric condition;
• a source of a sterile fluid substance;
• and
• a filler for introducing the sterile fluid substance into a plurality of sterilized containers while the plurality of sterilized containers are within the sterile isolator.

An apparatus for producing sterilized, prefilled syringe bodies comprising:

• a sterilizing station for sterilizing a syringe body;
• a sterile isolator comprising an opening for receiving a sterilized syringe body;
• a sterile ambient atmospheric condition adjacent the opening;
• a transport mechanism for transferring a sterilized syringe body from the sterilizing station to the sterile isolator wherein the sterilized syringe body is exposed to the sterile ambient atmospheric condition;
• a source of a sterile fluid substance;
• and
• a filler for introducing the sterile fluid substance into a sterilized syringe body while the sterilized syringe body is within the sterile isolator.

An apparatus for continuous in-line production of a plurality of sterilized, prefilled syringe bodies comprising:

• a sterilization station comprising a means for continuously sterilizing a plurality of syringe bodies;
• a sterile isolator comprising an opening for continuously receiving a plurality of syringe bodies;
• a sterile ambient atmospheric condition adjacent the opening;
• a transport mechanism for continuously transferring a plurality of sterilized syringe bodies from the sterilizing station to the sterile isolator wherein the plurality of sterilized syringe bodies are exposed to the sterile ambient atmospheric condition;
• a source of a sterile fluid substance;
• and
• a filler for introducing the sterile fluid substance into a plurality of sterilized syringe bodies while the plurality of sterilized syringe bodies are within the sterile isolator.

An apparatus for directly receiving a molded, polymeric container from a container forming process and producing a sterilized, prefilled container comprising:

• a sterilization station comprising a means for sterilizing a container;
• a means for transporting a container from a container forming process to the sterilization station;
• a sterile isolator comprising an opening for receiving a sterilized container;
• a sterile ambient atmospheric condition adjacent the opening;
• a transport mechanism for transferring a sterilized container from the sterilizing station to the sterile isolator wherein the sterilized container is exposed to the sterile ambient atmospheric condition;
• a source of a sterile fluid substance;
• and
• a filler for introducing the sterile fluid substance into a sterilized container while the sterilized container is within the sterile isolator.

A method of in-line, continuous production of sterile prefilled containers, the method comprising the steps of:

• providing a container;
• sterilizing the container;
• providing a sterile environment;
• providing a sterile ambient atmospheric condition adjacent the sterile environment;
• transferring the sterilized container to the sterile environment while exposing the sterilized container to the sterile ambient atmospheric condition;
• providing a source of a medical solution;
• and
• introducing the medical solution into the sterilized container while the sterilized container is within the sterile environment.

A method of in-line, continuous production of sterile prefilled containers, the method comprising the steps of:

• providing a container having no secondary packaging;
• sterilizing the container;
• and
• transferring the container to a sterile environment while exposing the container to ambient conditions;
• providing a source of a medical solution;
• and
• introducing the medical solution into the sterilized container while the sterilized container is within the sterile environment.

A method of producing a sterile prefilled container for medical purposes, the method comprising the steps of:

• providing a container;
• sterilizing the container;
• providing a sterile environment;
• transferring the sterilized container to the sterile environment while exposing the container to ambient conditions;
• providing a fluid substance;
• introducing the fluid substance into the container while the container is within the sterile environment;
• and
• sealing the fluid substance within the container while the container is within the sterile environment.

A method of in-line, continuous production of sterile prefilled syringe bodies for medical purposes, the method comprising the steps of:

• forming a plurality of syringe bodies by injection molding;
• arranging the plurality of syringe bodies in a predetermined order on a transfer mechanism;
• transferring the plurality of syringe bodies along the transfer mechanism to a sterilizing location;
• sterilizing the plurality of syringe bodies;
• transferring the plurality of sterilized syringe bodies to a sterile environment while maintaining the plurality of syringe bodies in a sterilized condition;
• providing a fluid substance within the sterile environment;
• introducing the fluid substance into the plurality of syringe bodies while the plurality of syringe bodies are within the sterile environment;
• and
• sealing the fluid substance within the plurality of syringe bodies while the plurality of syringe bodies are within the sterile environment.

A method of continuously producing a plurality of sterile prefilled syringe bodies for medical purposes, the method comprising the steps of:

• providing a plurality of syringe bodies;
• arranging the plurality of syringe bodies within a transfer tray;
• sterilizing the plurality of syringe bodies and the transfer tray substantially simultaneously;
• transferring the plurality of sterilized syringe bodies and the sterilized transfer tray to a sterile environment while exposing the plurality of syringe bodies and the transfer tray to a sterile ambient atmospheric condition;
• providing a fluid substance;
• and
• introducing the fluid substance into each syringe body individually while the plurality of syringe bodies are within the sterile environment.

A method of continuously producing a plurality of sterile prefilled syringe bodies for medical purposes, the method comprising the steps, in sequence of:

• providing a syringe body;
• sterilizing the syringe body;
• transferring the sterilized syringe body to a sterile environment while exposing the syringe body to a sterile ambient atmospheric condition;
• providing a fluid substance;
• and
• introducing the fluid substance into the syringe body while the syringe body is within the sterile environment.

A method of providing a prefilled polymeric container and controlling a solution pH of a sterile, parenteral solution within the polymeric container, the method comprising the steps of:

• providing a container produced from a polymeric material where an ionizing radiation causes the formation of free radicals on the container;
• providing a source of ionizing radiation;
• sterilizing the polymeric container with a predetermined dose of the ionizing radiation;
• providing a source of a parenteral solution;
• introducing the parenteral solution into the container within 48 hours of sterilizing the polymeric container with a predetermined dose of the ionizing radiation;
• and
• sealing the parenteral solution within the polymeric container.