Bulk powder sampler with removable partitions and method of...

Measuring and testing – Sampler – sample handling – etc. – Capture device

Reexamination Certificate

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C073S864640

Reexamination Certificate

active

06339966

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to bulk sampling devices, and more particularly, to improved bulk sampling devices having removable partitions to form non-communicating adjacent sample ports, and their method of use.
2. Description of the Related Art
In the manufacture of pharmaceutical dosage forms, one of the critical processing steps is the blending of the active ingredient(s) with the inactive ingredient(s) in a blender or mixer. This step becomes even more critical in case of solid dosage forms, such as tablets and capsules, because the dry powders of the active ingredient(s) and the inactive ingredient(s) tend to segregate or separate after blending resulting in non-uniform distribution of the active ingredient(s) in the finished product. Therefore, before further processing of such blends, bulk samples are taken from different places in these blends and analyzed to check whether or not the active ingredient(s) is uniformly distributed or not. Such a test is known in the trade as a content uniformity test or a homogeneity test, and requires unit-dose samples with sample size equal to about one dose of the product. My prior U.S. Pat. Nos. 5,337,620, and 5,440,941 describe sampling devices used for unit-dose sampling. In addition to unit-dose sampling, bulk samples are also needed in order to perform physical tests, such as particle size distribution, bulk density, moisture content, etc.
Several types of bulk sampling devices are available in the market for the purpose of bulk sampling. Some of these devices are comprised of a single tube with a long cavity on it. Some others have a tube within a tube with multiple sample ports on the tubes with or without partitions. However, the partitions on these samplers are permanently welded in place, and it is very difficult to clean behind these partitions. In addition, these samplers with permanent partitions do not offer the possibility of using the sampler without the partitions, if desired.
The present invention overcomes the problems associated with the currently available bulk samplers by providing a bulk sampling device which has removable partitions, thus making it possible to clean the sampler to good manufacturing practice standards, and also offering the flexibility of using the sampler with or without the partitions in order to obtain discrete samples from different locations or one composite core sample.
A number of patents have been issued that address numerous sampling devices and techniques of various materials will be discussed herein.
U.S. Pat. No. 5,337,620 issued to Kalidindi on Aug. 16, 1994 teaches a multiple sampling device and method of using the same, having removable sampling dies located within a receiving a rod placed in a tubular casing. U.S. Pat. No. 5,440,941 issued to Kalidindi on Aug. 15, 1995 teaches an extendable multi-segmented sampling device and method of using the same, containing sampling dies having cavities of varying volumes located within an extendable, segmented receiving rod that is placed in an extendable, segmented tubular casing.
Italian Patent No. 484,331 issued on Nov., 1954 to Dino consists of an inner tube containing partitioned volume with apertures for each compartment, an outermost tube, and an intermediate tube with apertures which align with both the inner tube's apertures and corresponding apertures in the outermost tube. A portion of the second tube's apertures contains a filter. The innermost tube and the intermediate tube have separate handles for alignment of their respective apertures with the apertures of the outer tube in order to take samples of an immiscible liquid system. There is no disclosure of a bulk sampling device having removable partitions between non-communicating sample ports or a handle having multi-setting positions, a separate cone tip, or operation of his sampler without the essential intermediate tube and associated filters.
In U.S. Pat. No. 4,790,198 issued on Dec. 13, 1988 to Jon Awtry et al. teaches a grain probe having an inner tubular member's openings aligned with the outer tubular member's opening to take grain samples. The grain probe has a pointed end to aid in the penetration of the grain pile. There is no disclosure of a bulk sampling device having removable partitions between non-communicating sample ports or a handle having multi-setting positions, or the removability of the pointed end.
U.S. Pat. No. 3,080,760 issued on Mar. 12, 1963 to Henry D. Piersma teaches a disposable sample probe for bulk chemicals including powder. The probe is a simple two-tube device with alignment of separate cavities with the outer tube's apertures for taking samples. Again, there is no suggestion of a bulk sampling device having removable partitions between non-communicating sample ports or a handle having multi-setting positions.
U.S. Pat. No. 2,694,931 issued on May 9, 1952 to R. G. Handley teaches a sectional deep bin grain sampling and measuring probe comprising a string of separable straight cylindrical sections, united by a flexible chain, and that form internal sample grain receiving chambers.
U.S. Pat. No. 3,065,637 issued on Dec. 7, 1959 to J. T. Landes teaches sectional grain test sampling and measuring probe for removing grain samples at different levels. The sampling probe comprises a point section, a handle section and an intermediate section adapted to be separably connected, and dissembled, such as for cleaning purposes.
U.S. Pat. No. 2,875,615 issued on Mar. 3, 1959 to Orrion A. Ulvin teaches a grain and seed probe sampling device which utilizes a spiral element within an apertured outer tube. However, the sampling device disclosed in Ulvin does not have removable partitions between non-communicating sample ports.
U.S. Pat. No. 4,744,256 issued on May 17, 1988 to Shale J. Niskin teaches water sampler device dropped from an airplane to obtain a single sample by utilizing a valving arrangement to open and close the sampler.
U.S. Pat. No. 2,185,651 issued on Jan. 2, 1940 to John Soiethere teaches a milk sampler including a rod with attached handle to reduce sample volume, capacity.
U.S. Pat. No. 4,660,423 issued on Apr. 28, 1987 to John M. Armstrong et al., teaches a water sampling apparatus wherein sampling is initiated by in situ puncturing of a sealed tube to obtain one sample.
German patent document DD 285,639 A5 published on Dec. 19, 1990 to Rolf Hoffman et al. teaches a sampling device where the chamber is rotatable to receive and discharge a sample.
USSR patent 204,682 issued on Jul. 28, 1967 to G. K. Kushchanov there discloses a sampler consisting of a pipe having inclined shelves. The pipe is disposed within a cylindrical body having ports and gates to allow samples to be collected as the device is axially rotated.
U.S. Pat. No. 2,968,184 issued on Jan. 17, 1961 to James R. Archer et al. teaches a sampling tube having a receiving member and a cover member. The cover member is slidable relative to the receiving member which is in the form of a tube and has holes cut therein. The device can be inserted into a material to be sampled and the cover is slid back to allow the material to enter the holes in the receiving member. The cover is then slid back into a closed position and the device is withdrawn.
Finally, U.S. Pat. No. 4,442,721 issued on Apr. 17, 1984 to Laura G. Singer discloses a soil moisture and consistency sampler comprising an elongate member with an insertable end, a handle end, and a plurality of generally transverse collecting means disposed proximate the insertable end that define soil collecting pockets.
None of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus a bulk sampling device having removable partitions between non-communicating sample ports and method of using and cleaning the same, as well as solving the aforementioned problems are desired.
SUMMARY OF THE INVENTION
Accordingly, it is a principal object of the invention to provide a bulk sampling de

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