Chemistry: analytical and immunological testing – Including sample preparation
Reexamination Certificate
1999-02-10
2002-07-23
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Including sample preparation
C436S180000, C422S091000, C422S105000, C422S105000, C422S105000, C073S863000, C073S863450, C073S863710, C073S864000, C073S864230, C073S864310
Reexamination Certificate
active
06423548
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for capturing a sample of flowable material from a closed system inside a receptacle without exposing the sample to the ambient environment. The present invention would find broad application in the pharmaceutical and biotechnology industries as well as the fine chemical, food and beverage industries where obtaining accurate, uncontaminated samples of process flows from closed systems while maintaining the integrity of those systems and/or the sample is important
2. Description of the Background Art
Development of new or more efficient commercialization of existent products requires faster and more effective methods to measure process variables. This is particularly true in processes which require cell culture and fermentation processes conducted in bio-reactors where the accuracy of measurements and research and development are critical for achieving economic production of high purity and highly refined end products.
Some factors which must be controlled include temperature and pressure. These factors are easily measured by utilization standard sensors. However, many other factors can be measured only by removing samples for external laboratory analysis. The frequency of sample extraction for testing and measurement, the number of tests on each sample, and the time constraints on the process vary widely as do the methods and equipment used to obtain the samples.
In most cases, measurement processes for variables do not lend themselves to in-situ measurement by remote sensors directly in the process. Instead, samples must be physically extracted from the processes and examined and manipulated outside the vessel or conduit. Before this examination and manipulation process can be effectively carried out either in a manual or an automated fashion, a safe, effective means of sample extraction must be made available. This sampling process must provide a product that is an accurate sub-sample of the process composition.
Furthermore, since prior art designs do not lend themselves to use in existing systems, substantial modification to the system is required. The apparatus needs to minimize or eliminate the dangers associated with the sampling process in an efficient and cost effective manner, while providing quality, reproducible results in order to be of value for commercial application.
One danger which must be avoided is danger to the operator or environment. When working with samples and especially hazardous samples, it is necessary to remove or feed/inoculate a sample without endangering the integrity of the process, subsequent samples, the operator, or the outside environment. Many prior art devices are unsatisfactory in this area.
Some prior art systems are not automated. Therefore, there is potential danger posed by human procedural errors and operator and environmental exposure. Accordingly, a need exists for an automatable apparatus with a capacity for independent verification of equipment operation built in.
In some cases, the materials being sampled are often expensive. Therefore, excessive removal of a sample should be avoided.
When taking samples, it is often important to maintain an aseptic environment. It is important that contamination from previous sampling or from the environment not contaminate the current sample or the process being sampled. Loss of a sample run or contamination of the process can have extremely expensive ramifications. Therefore, it is important to obtain a sample without the sampling procedure causing contamination.
Many prior art devices permit accumulation or pooling of samples or cleansing medium. When the device is first used it may not create a problem; however, upon subsequent runs, the samples will be contaminated or at least diluted.
The Disclosures of U.S. Pat. Nos. 5,296,197, 5,525,301, and 5,786,209 relate to automated sample extractors or feeder/inoculates for bio-reactors and similar equipment. The Disclosures of these patents are hereby incorporated by reference.
The above-mentioned patents relate to removing a sample from a vessel or conduit without contamination of the sample, process, or surrounding environment. The present invention is usable with devices of this type or with similar devices. Namely, once the sample is removed from the vessel or conduit, it becomes necessary to feed the sample into a receptacle for later processes or testing.
In the past, sampling from a vessel or conduit was performed by hand by an operator. This manual sampling ran the risk of exposure to dangerous substances by the operator as well as contaminating the sample.
SUMMARY OF THE INVENTION
Accordingly, it is a primary object of the present invention to provide a simple, reliable, safe, and cost effective means for capturing a sample of flowable material from a closed system inside a receptacle and stoppering the receptacle without exposing the sample or the material to the surrounding outside environment.
It is another object of the present invention to capture a sample of flowable material from a closed system inside a receptacle without subjecting an operator to dangerous substances.
It is a further object of the present invention to capture a sample of flowable material from a closed system in order to obtain sterile samples which can be kept pure for a longer period of time.
It is yet a further object of the present invention to provide an apparatus which can be retrofitted to existing standard equipment without substantial modification.
It is yet another object of the present invention to provide an apparatus which will conduct sampling and maintain the sample in a sealed arrangement such that there is no danger to the sample itself, to the operator, to the process, or to the surrounding environment.
It is yet another object of the present invention to provide a device which can protect an operator from the sampled material by isolating it in a container, whether or not maintaining the integrity of the process or sample itself is important.
It is a further object of the present invention to provide an automatable system in order to eliminate possible operator error.
It is a further object of the present invention to provide a receptacle for collecting a sample within a sealed environment so that the area approximate the receptacle can be cleansed or sterilized and therefore be kept free from contaminates. The receptacle can be a receptacle and stopper combination, and the stopper can be removed within the cleansed or sterilized environment, the receptacle can be filled with the sample, and the stopper can be reattached to the receptacle all within the cleansed or sterilized environment.
It is a further object of the present invention to allow the receptacle and/or stopper to be washed, rinsed, disinfected, and/or sterilized in place using any of a variety of flowable materials at ambient, reduced, or elevated temperatures.
Another object of the present invention is to provide an apparatus which can be repeatedly cleaned and/or sterilized in place.
Yet another object of the present invention is to provide an apparatus which can be easily removed and quickly disassembled for maintenance, including replacement of worn parts.
A further object of the present invention is to provide an apparatus made of materials which are compatible with the sample materials and the process.
Still another object of the present invention is to provide an apparatus which will be reliable, easy to maintain, and low in cost.
These and other objects of the present invention are fulfilled by providing an apparatus for capturing a sample of flowable material from a closed system inside a receptacle and stopping the receptacle without exposing the sampled material to the surrounding outside environment.
The device for sampling flowable material includes a housing for receiving a receptacle therein. This housing includes an end-cap removably mounted to the housing for allowing a receptacle to be inserted into the housing and removed therefrom. The housing also includes an inl
Newberg Douglas A.
Newberg Richard R.
Bex Kathryn
NL Technologies, Ltd.
Warden Jill
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