US20210205857A1

US20210205857A1 - Processing method and device for small parts

Info

Publication number: US20210205857A1
Application number: US17/209,805
Authority: US
Inventors: Eric Netzhammer
Original assignee: Individual
Current assignee: Castus Sterile Systems GmbH and Co KG
Priority date: 2016-03-02
Filing date: 2021-03-23
Publication date: 2021-07-08
Also published as: US20190118228A1; JP2019508243A; CH712243A1; WO2017149029A2; EP3423114B1; CN109310790A; EP3423114A2; WO2017149029A3; US10981200B2

Abstract

The processing device for small parts is equipped with ultrasound probes for decreasing the number of particles and with microwave generators for drying the small parts.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional application of co-pending application Ser. No. 16/081,710, filed on Aug. 31, 2018, which is the National Phase under 35 U.S.C. § 371 of International Application No. PCT/EP2017/054803, filed on Mar. 1, 2017, which claims the benefit under 35 U.S.C. § 119(a) to Patent Application No. 00268/16, filed in Switzerland on Mar. 2, 2016, all of which are hereby expressly incorporated by reference into the present application.
The invention relates to a method and a device for conservational processing of bulk quantities of small parts in a container.
For the purpose of this description, the term “bulk quantities” refers to a quantity of small parts filled, that is, poured, in an unsorted manner, into a processing container, processed in the container, and then removed from the container, still unsorted. This type of the processing is for parts that are typically employed in the pharmaceutical or medical field, that is, parts of syringes, ampules, etc.
Consequently, for the purpose of this description, the term “small parts” relates to the unsorted individual parts of a bulk quantity, in particular small parts for use in the medical or pharmaceutical field.
In known devices for treating such small parts, the following quality-relevant standard processes are executed:

- Washing to decrease the number of particles, to decrease the number of endotoxins, to decrease the number of other substances (e.g. organic residual substances on the surface), etc.
- Sterilizing with steam to provide sterile parts
- Drying to reduce the residual moisture in the parts and on their surfaces.

For the washing process, the parts are dipped in water and air is blown onto them from below. This creates a so-called fluidized bed that moves the small parts and holds them in suspension. During this process, particles and other substances are washed out during and, using appropriate evacuation, with the water are separated from the small parts.
The known washing processes are able to decrease the number of particles and other substances, but often to an unsatisfactory extent. In particular, it is difficult to remove heavy particles, because the known processing machines can only be emptied from above. Since the small parts are employed in pharmaceutical and medical applications (e.g. injection ampules), decreasing the number of particles in particular is a critical quality feature.
In the known devices, drying of the small parts is accomplished using a vacuum and hot air.
The known drying processes are able to produce low residual moisture, which is medically often no longer adequate, however. On the one hand, residual water may be in the pores of the small parts, and this residual water may not be removed with the conventional processes. On the other hand, there may also be residual moisture on the surface. These residual moistures may have a profoundly negative impact on shelf-life, e.g. for lyophilized active substances. In addition, the drying time may take a number of hours until low residual moisture values are attained.
Another drawback of known processing devices is that, after one processing cycle and the emptying of the processing container, individual parts may remain in the container and consequently be processed multiple times. In particular, however, it is possible for different types of parts to be mixed, which may lead to problems in the subsequent machines.
The underlying object of the invention is to prevent or improve the aforesaid drawbacks of the prior art.
According to the invention, this is attained using a method and a device of the type identified in the foregoing that are distinguished by the characterizing features of claims 1 and 2.
The processing container is a rotating container that is rotatable in a cart or in a frame (prior art). Depending on what is required, it is provided with a filling option and a transfer system according to the prior art.
The container is equipped with one or a plurality of ultrasonic generates.
The container is equipped with a perforated sheet on which the small parts are disposed.
The container is filled with water so that the ultrasonic generator and parts are completely submerged. The parts are now cleaned with ultrasound.
Once the cleaning has been accomplished, the water level is reduced so that the heavy particles can move downward and leave the processing container. Then the liquid level is raised until there is an overflow so that the light particles are removed.
The container is equipped with one or a plurality of microwave generators. The small parts are dried using microwaves.
Ultrasound cleaning and microwave drying may be combined, or may even just be used individually. This depends, inter alia, on the nature of the material for the parts.

Preferred exemplary embodiments of the invention are described in the following using the attached drawings.

FIG. 1 is a sectional schematic diagram of an inventive processing device;

FIG. 2 is a sectional schematic diagram of another form of an inventive processing device, shown closed;

FIG. 3 is a sectional schematic diagram of the processing device illustrated in FIG. 2, shown open here.

The processing container 1 illustrated in FIG. 1 has a cylindrical side wall 2, known per se, having an attached flange-like arched bottom 3. A perforated sheet (not shown) is also arranged in the region of the flange in a manner known per se. An inlet connection 4 for processing media is disposed in the bottom. At the other end of the container, connected to the side wall is a conical region 5 at which an inlet and outlet connection for the small parts 6 to be processed is disposed.
Arranged on the side wall is an ultrasound generator 7 that acts on the container contents with ultrasound waves to clean the container contents better.
In addition, arranged on the side wall is a microwave generator 8 that, after the cleaning phase, acts on the container contents with microwaves to promote drying of the container contents.
In the processing container illustrated in FIGS. 2 and 3, a part 9 of the conical region is connected to the container by means of a flange 10 and a hinge device 11. The flange is embodied in a manner known per se such that it may be released easily. In this way the aforesaid part 9 of the conical region of the container may be flipped open, as shown in FIG. 3, to form an opening sufficiently large for manual inspection. The processed parts may also be emptied through this opening, since the container is rotatably borne on a cart.

Claims

1. A method for conservational processing of bulk quantities of small parts in a container, characterized in that the small parts are subject to at least the steps of ultrasound cleaning in a water bath as well as subsequent sterilization and drying by being acted upon with microwaves.