Sterile sampling methods and apparatus
First Claim
1. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:
- an inlet tube having proximal and distal ends, and the proximal end is connected to an inlet of a sterile sight chamber, the chamber comprising;
a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and
an outlet;
the inlet tube comprising a tube clamp thereon, wherein the tube clamp is located between the distal end and the sight chamber so as to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp;
the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and
a sample port comprising a hollow body with a distal end and a proximal end, wherein the distal end of the sample port is connected to the outlet of the chamber, and the proximal end is opposite the outlet.
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Abstract
An apparatus and method that allow multiple samples of a liquid in a primary container (here called a ‘pouch’) to be taken with minimal danger of contaminating the liquid in the container during the sampling process are disclosed. In an embodiment, a closed sterile sight chamber is connected with the pouch in a sterile manner to allow fluid to flow into the chamber white at the same time allowing air within the chamber to be displaced through a bacterial fitter to atmosphere. The connection between the sight chamber and the pouch is then terminated (severed or closed), isolating the pouch from the sampling apparatus. Only then are samples of liquid withdrawn from the sight chamber, while allowing air to flow into the chamber through the bacterial filter.
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Citations
38 Claims
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1. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:
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an inlet tube having proximal and distal ends, and the proximal end is connected to an inlet of a sterile sight chamber, the chamber comprising; a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and an outlet; the inlet tube comprising a tube clamp thereon, wherein the tube clamp is located between the distal end and the sight chamber so as to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and a sample port comprising a hollow body with a distal end and a proximal end, wherein the distal end of the sample port is connected to the outlet of the chamber, and the proximal end is opposite the outlet. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 19, 20)
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12. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:
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a flexible thermoplastic inlet tube having proximal and distal ends, and the proximal end is connected to an inlet of a sterile sight chamber, the chamber comprising; a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and an outlet; the inlet tube comprising a tube clamp thereon, wherein the tube clamp is located between the distal end and the sight chamber so as to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; and the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection wherein; the sight chamber is tubular and transparent and has an upper end and a lower end; the inlet is located at the upper end, and the outlet is located at the lower end; the vent is located at the upper end; the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent. - View Dependent Claims (13, 14, 15, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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16. A method for providing at least one sample of liquid from a quantity of liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the method comprising:
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providing a pouch comprising a sterile fluid connection between the pouch and a flexible thermoplastic inlet tube having proximal and distal ends, the proximal end connected to an inlet of a sterile sight chamber, the chamber comprising; a vent in the chamber wall fitted with a bacterial filter through which air can flow to and from the chamber; and an outlet; the inlet tube comprising a tube clamp thereon; opening the tube clamp and allowing a quantity of liquid to flow into the chamber from the pouch while venting displaced air from the chamber through the vent; closing the tube clamp to prevent fluid flow between the pouch and the chamber; after closing the tube clamp, terminating the connection between the pouch and the inlet tube; and after terminating the connection, withdrawing at least one sample of liquid from the chamber into at least one sample phial while allowing air to enter the chamber via the vent to replace the liquid withdrawn. - View Dependent Claims (17, 18, 33, 34, 35, 36, 37, 38)
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Specification