The present invention relates to sampling systems and, more specifically, to a powder sampling system.
Sampling of blended powders, such as blended pharmaceutical powders, is required by the FDA. Many companies have sampling problems, which cause bad assay values, bad uniformity values, etc. A typical sampling thief includes a sampling rod that defines an opening into which powder may flow and a tube around the rod that can be repositioned to close off the opening. The sampling thief is pushed into a powder being sampled, the tube is positioned to open the opening and then repositioned to close the opening to trap powder samples therein. The air released from the opening can cause fluidization separation of the components in the blended powder, which can result in a sample that does not correctly represent the actual mixture of the blended powder.
Some labs attempt to overcome such problems with statistical procedures, which can be suitable when the analytical results for the finished dosage form (tablets or capsules) are found to meet specifications. However, such procedures can be cumbersome and frequently leave room for doubt as to whether the blended powder was truly homogeneous.
Therefore, there is a need for sampling thief that samples blended powders so that the samples accurately represent the actual blend of the powders being sampled.
The disadvantages of the prior art are overcome by the present invention which, in one aspect, is a blended powder sampling thief for sampling a powder. An elongated rod has an upper portion and a lower portion. The lower portion defines at least one cavity. A tubular sheath is disposed about the rod and is slidable between a lower position in which the tubular sheath exposes the at least one cavity and an upper position in which the at least one cavity is exposed. When the rod is inserted into the powder and the tubular sheath is in the upper position, the powder flows into the at least one cavity. When the tubular sheath is slid into the lower position, a sample of the powder is entrapped in the at least one cavity so that when the sampling thief is removed from the powder, the sample of the powder will remain in the at least one cavity.
In another aspect, the invention is a blended powder sampling system for sampling a powder. A sampling container holds the powder therein. An elongated rod has an upper portion, a lower portion and a pointed lower end. The lower portion defines at least one cavity. A tubular sheath is disposed about the rod and is slidable between a lower position in which the tubular sheath exposes the at least one cavity and an upper position in which the at least one cavity is exposed. When the rod is inserted into the sampling container and the tubular sheath is in the upper position, the powder flows into the at least one cavity. When the tubular sheath is slid into the lower position, a sample of the powder is entrapped in the at least one cavity so that when the sampling thief is removed from the powder, the sample of the powder will remain in the at least one cavity.
In yet another aspect, the invention is a blended powder sampler for sampling a powder that includes a sampling thief and a sampling container. The sampling thief that includes an elongated rod and a tubular sheath. The elongated rod has an upper portion and a lower portion. The lower portion defines a plurality of cavities. The tubular sheath is disposed about the rod and that is slidable between a lower position in which the tubular sheath exposes the plurality of cavities and an upper position in which the plurality of cavities is exposed. The sampling container includes a jar into which the powder is placed and a sampling funnel that is affixable to the jar. The sampling funnel defines a passage that is complimentary in shape to the tubular sheath so that that the power sampling thief is held closely as it is being slid into the powder. The passage is elongated so as to keep the sampling thief at a constant angle relative to the jar as it is inserted into the powder. When the rod is inserted into the sampling container and the tubular sheath is in the upper position, the powder flows into the plurality of cavities. When the tubular sheath is slid into the lower position, samples of the powder are entrapped in the plurality of cavities so that when the sampling thief is removed from the powder, the samples of the powder will remain in the plurality of cavities.
These and other aspects of the invention will become apparent from the following description of the preferred embodiments taken in conjunction with the following drawings. As would be obvious to one skilled in the art, many variations and modifications of the invention may be effected without departing from the spirit and scope of the novel concepts of the disclosure.
A preferred embodiment of the invention is now described in detail. Referring to the drawings, like numbers indicate like parts throughout the views. Unless otherwise specifically indicated in the disclosure that follows, the drawings are not necessarily drawn to scale. The present disclosure should in no way be limited to the exemplary implementations and techniques illustrated in the drawings and described below. As used in the description herein and throughout the claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise: the meaning of “a,” “an,” and “the” includes plural reference, the meaning of “in” includes “in” and “on.”
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An embodiment that includes an air escape groove is shown in
Photographs of one representative embodiment of a sampling thief are shown in
The sampling thief of the president invention allows the rod to be turned 180° when the sampling thief is in the open position in the blended powder. This facilitates “grabbing” a fresh sample that does not include air released from the cavities and that is likely to be more representative for the true distribution of the active drug in the blend.
The three-cavity design requires only a one time entering of the powder blend to sample at three different levels simultaneously. This presents an advantage because this system does not disturb the powder bed, which could influence the quality of the samples.
According to many pharmaceutical protocols, the sample weight of the powder taken by the cavity is usually in a range of from one to three times a weight of a desired finished dosage form and should not exceed three times the finished dosage weight. (For example, if the tablet weight will be 250 mg, each of the blend samples should have a weight in a range between 250 mg to 750 mg.) To achieve this, the cavity should have dimensions such that the volume of the cavity divided by the density of the powder equals a sample weight within the desired range. The following formula can be used to determine the dimensions of the cavity:
where:
Although specific advantages have been enumerated above, various embodiments may include some, none, or all of the enumerated advantages. Other technical advantages may become readily apparent to one of ordinary skill in the art after review of the following figures and description. It is understood that, although exemplary embodiments are illustrated in the figures and described below, the principles of the present disclosure may be implemented using any number of techniques, whether currently known or not. Modifications, additions, or omissions may be made to the systems, apparatuses, and methods described herein without departing from the scope of the invention. The components of the systems and apparatuses may be integrated or separated. The operations of the systems and apparatuses disclosed herein may be performed by more, fewer, or other components and the methods described may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order. As used in this document, “each” refers to each member of a set or each member of a subset of a set. It is intended that the claims and claim elements recited below do not invoke 35 U.S.C. § 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim. The above-described embodiments, while including the preferred embodiment and the best mode of the invention known to the inventor at the time of filing, are given as illustrative examples only. It will be readily appreciated that many deviations may be made from the specific embodiments disclosed in this specification without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is to be determined by the claims below rather than being limited to the specifically described embodiments above.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/000,015, filed Mar. 26, 2020, the entirety of which is hereby incorporated herein by reference.
Number | Date | Country | |
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63000015 | Mar 2020 | US |