The present disclosure provides novel processes for providing sterile, pre-filled syringes or injection devices for pharmaceutical compositions, including protein and biopharmaceutical formulations. In some examples, secondary packaging is performed in an aseptic environment, which removes the need for any terminal sterilization method. In some examples, the aseptic packaging method results in a sterile injection device suitable for use in ophthalmic injections.

The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

A multilayer container for elevated temperature, high pressure processing of a material within the container, using a pressure transmission liquid within the container, the multilayer container having a container wall having an inner layer formed of a plastic for containing the liquid in contact with the inner side thereof and at least one further layer outboard of the inner layer and formed of different plastic from the inner layer, wherein the inner layer has a compression heating coefficient at least as high as the compression heating coefficient of the pressure transmission liquid in contact with the inner side thereof and the at least one further layer has a lower thermal conductivity at ambient pressure and temperature than the inner layer.

A multilayer container for elevated temperature, high pressure processing of a material within the container, using a pressure transmission liquid within the container, the multilayer container having a container wall having an inner layer formed of a plastic for containing the liquid in contact with the inner side thereof and at least one further layer outboard of the inner layer and formed of different plastic from the inner layer, wherein the inner layer has a compression heating coefficient at least as high as the compression heating coefficient of the pressure transmission liquid in contact with the inner side thereof and the at least one further layer has a lower thermal conductivity at ambient pressure and temperature than the inner layer.

A pharmaceutical mobile machine to produce a sterile dosage pharmaceutical form from non-sterile or sterile ingredients amenable for human dosing and administration, The pharmaceutical machine includes an ingredient combiner module including a mixer to mix active and inactive pharmaceutical ingredients and a transfer conduit to transfer the mixed ingredients from the ingredient combiner module. A final product module is operatively connected to the transfer conduit to receive the mixed ingredients from the ingredient combiner module. The final product module includes filling equipment to fill one or more containers to produce the sterile dosage pharmaceutical form. An environment module includes an air purifying system having an outlet operatively connected to the final product module, wherein the air purifying system provides purified air to the final product module through the outlet.

A pharmaceutical mobile machine to produce a sterile dosage pharmaceutical form from non-sterile or sterile ingredients amenable for human dosing and administration, The pharmaceutical machine includes an ingredient combiner module including a mixer to mix active and inactive pharmaceutical ingredients and a transfer conduit to transfer the mixed ingredients from the ingredient combiner module. A final product module is operatively connected to the transfer conduit to receive the mixed ingredients from the ingredient combiner module. The final product module includes filling equipment to fill one or more containers to produce the sterile dosage pharmaceutical form. An environment module includes an air purifying system having an outlet operatively connected to the final product module, wherein the air purifying system provides purified air to the final product module through the outlet.

A compact, on-demand mask folding and welding system which reduces the size, cost, noise hazard and complexity of the folding and welding process used in the manufacture of medical and protective face masks is disclosed.

The enclosed disclosure describes, among other things, a method including the steps of a first deaerating step in which a mixture comprising peptides is deaerated by lowering the pressure, filtering the mixture through a sterilizing filter; and a second deaerating step, in which the filtrate is deaerated by vibration and lowering the pressure.

The enclosed disclosure describes, among other things, a method including the steps of a first deaerating step in which a mixture comprising peptides is deaerated by lowering the pressure, filtering the mixture through a sterilizing filter; and a second deaerating step, in which the filtrate is deaerated by vibration and lowering the pressure.