Apparatus for quality control analysis of an on-site prepared pharmaceutical product

A disposable device for maintaining sterility of a hyperpolarized pharmaceutical product during quality control analysis of the product comprising:

• a receiver vessel to receive a sterile hyperpolarized pharmaceutical product therein;
• a sample tube having a first end attached to the receiver vessel, the sample tube configured to remove the hyperpolarized pharmaceutical product from the receiver vessel;
• an appendage connected to a second end of the sample tube, the appendage having at least one chamber therein to receive a quantity of pharmaceutical product from the receiver vessel while maintaining sterility of the hyperpolarized pharmaceutical product;
• and
• a one-way sterile valve positioned within the sample tube to control flow of the hyperpolarized pharmaceutical product to the appendage and prevent flow of the hyperpolarized pharmaceutical product from the appendage back into the receiver vessel;
• an automated displacement mechanism directly attached to the receiver vessel and configured to apply pressure to said receiver vessel to allow displacement of the hyperpolarized pharmaceutical product from said receiver vessel into the appendage;
• and
• wherein the disposable device is comprised of a material that is non-reactive to the hyperpolarized pharmaceutical product.