Patent Description:
Valves, such as split butterfly valves, are available in many designs and used widely for processes where product containment is required to prevent product exposure to the environment and to personnel working in close proximity to the product. Split butterfly valve designs allow the valve to be split open into two units, commonly known as active and passive units. The valve design is such that when split, the two halves keep the contents on either side sealed and contained.

In the manufacture of pharmaceuticals, chemicals, biological material and food, effective containment is essential for the safe and hygienic handling of such compounds and materials. At each stage of the manufacturing process, handling must be controlled and managed to provide optimum protection for the operator and for maintaining the integrity of the product.

The material being handled is often hazardous to health, owing to the increasing potency of many new pharmaceutical ingredients. Pharmaceutical and bio-manufacturing products are often manufactured under strict controls against product contamination. This is because the products are often for human consumption and the industries are heavily regulated by bodies like the FDA (Food and Drug Administration) in the United States and the MHRA (Medicines and Healthcare products Regulatory Agency) in the United Kingdom. Furthermore, the pharmaceutical products, such as active pharmaceutical ingredients and/or subsequently diluted powders, may in sufficient quantities be hazardous to the health of an operator. It is therefore necessary to avoid direct contact between an operator and the potentially hazardous material. Owing to such stringent requirements for there to be a good seal between the active and passive units of the split valve to prevent product exposure to the environment and to personnel working in close proximity of the product, manufacture of the elements of the valve are under stringent conditions to ensure that the dimensions of the elements are precisely manufactured to ensure stringent tolerances are met.

It is important when operating the valve to ensure that the valve is opened and closed in a recommended or predetermined manner as prescribed by the operator manual accompanying the valve. However, poor communication and training, sometimes coupled with a lack of operator attentiveness, can often mean that the valve is operated in an incorrect manner, which significantly increases the risk of critical failure, misuse or unplanned maintenance.

<CIT> discloses a valve with a smart handle for a gas bottle;.

It is an object of the present invention to overcome or alleviate one or more of the problems associated with the operation of valves in the prior art.

According to the present invention there is provided an apparatus for providing operator feedback in response to opening or closing of a valve or coupling.

In particular, the invention is defined by apparatus claim <NUM>, as well as the corresponding method claim <NUM> and corresponding computer program claim <NUM>. Further preferred embodiments are defined by dependent claims <NUM>-<NUM>.

It is believed that a system and method for providing opening and/or closing feedback to an operator of a valve or coupling in accordance with the present invention at least addresses the problems outlined above. The advantages of the present invention are that a system and method is provided which ensures that a manual valve or coupling is operated in a safe and efficient manner, and which allows for the transfer of a product from one container or process vessel to another whilst minimising the levels of dust emission to the operating environment. Providing opening and/or closing feedback to the operator advantageously reduces the occurrences of critical valve failure, and may reduce excessive wear on viscoelastic valve components and seats, and thus reducing both planned downtime and unforeseen failure of valve components.

It will be obvious to those skilled in the art that variations of the present invention are possible and it is intended that the present invention may be used other than as specifically described herein.

Specific non-limiting embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings, in which:.

Referring now to the drawings, a system for providing opening and/or closing feedback to an operator of a valve or coupling is illustrated in <FIG> and <FIG>. <FIG> and <FIG> show how the present invention can be embodied in a valve-actuating handle <NUM> for manual operation of split valve assemblies.

As shown in <FIG>, the valve-actuating handle <NUM> is formed having a solid handle shaft or arm <NUM>; one end of which forms a knob <NUM>. The other end of the handle shaft or arm <NUM> is secured to a hub <NUM> which is formed as a unitary, machined part. As best illustrated in <FIG>, the rear face of the hub <NUM>, i.e. the face that is placed in contact with the split valve assembly <NUM>, defines a socket <NUM> which is dimensioned to connect with a square spigot <NUM> on the split valve assembly <NUM>, as best illustrated in <FIG>.

The front face of the hub <NUM>, i.e. the face that is visible to the operator, is generally circular in shape.

As best shown in <FIG>, the hub <NUM> includes a generally annular housing <NUM> into which a printed circuit board (PCB) <NUM> and power source or battery <NUM> is secured via fixing screws <NUM>. A colour liquid crystal display (LCD) <NUM> is positioned inside the aperture in the housing <NUM>, opposite the PCB <NUM>. The colour LCD display <NUM> is then secured in a screen sub-assembly <NUM> which includes a protective, transparent screen or window <NUM> at its centre and operation or function buttons <NUM> positioned around the radius of the screen sub-assembly <NUM> for ease of access. The buttons <NUM> include a power on/off button, standby and/or one or more function buttons.

As the valve-actuating handle <NUM> is intended to be used in environmentally-challenging conditions, including containing, regulating and controlling hazardous powders, dust, granular and semi-solid ingredients, the housing <NUM> and screen sub-assembly <NUM> are secured together using assembly screws <NUM> and internal O-ring seals <NUM> which secure the housing <NUM> and screen sub-assembly <NUM> to the hub <NUM> against a circumferential seal <NUM>.

To provide opening and/or closing feedback to the operator of the split valve assembly <NUM>, the PCB <NUM> includes various hardware, software, sensors and components, as best illustrated schematically and described in detail in relation to <FIG>.

<FIG> and <FIG> show how the present invention can be embodied in a valve-actuating handle <NUM> for manual operation of a valve or coupling, and particularly a split valve assembly <NUM> for containing, regulating and controlling hazardous powders, dust, granular and semi-solid ingredients. In use, the rear face of the hub <NUM>, i.e. the face that is placed in contact with the split valve assembly <NUM>, includes a socket <NUM> which is dimensioned to connect with the square spigot <NUM> on the split valve assembly <NUM>, as shown in <FIG> and <FIG>. Operator rotation of the valve-actuating handle <NUM> controls respective pivotally-mounted valve closure members (not shown) inside the split valve assembly <NUM>.

In an alternative embodiment, the hub <NUM> would be secured to the split valve assembly <NUM>, with the valve-actuating handle <NUM> being rotatable within the body of the hub <NUM> to rotate socket <NUM>. In this manner, the LCD display <NUM>, and the operation and/or function buttons <NUM> positioned around the radius of the screen sub-assembly <NUM>, are positioned in a fixed orientation for the user.

As shown in <FIG> and <FIG>, the split valve assembly <NUM> comprises two valve portions, an upper, passive valve portion <NUM> and a lower, active valve portion <NUM>. The passive valve portion <NUM> defines a valve housing <NUM> which is generally annular in shape. The active valve portion <NUM> defines a valve housing <NUM> which is also generally annular in shape. The two valve portions <NUM>, <NUM> are complementarily shaped such that one can sealingly engage and co-operate with the other to allow the movement of material therethrough. Although not shown in <FIG> and <FIG>, each valve potion includes valve closure members which are pivotally-mounted within the housings <NUM>, <NUM>. Each valve closure member is in the form of an annular disc, and each is provided with spindles by means of which each valve closure member is pivotally rotatable.

Although not shown in <FIG> and <FIG>, the spindle of the lower, active valve portion <NUM> is connected to, or is integrally formed with, spigot <NUM>. Thus, rotation of the spindle is moved by rotation of the spigot <NUM>. The spindle of the upper, passive valve portion <NUM> is connected to spigot <NUM>. A mechanical safety interlock ensures the safe operation of the split valve assembly <NUM>. When the two valve portions are correctly docked, the mechanical interlock pin <NUM> on the active valve portion <NUM> releases the profiled release pin <NUM> on the active valve portion <NUM> which allows the valve disc to be opened by rotation of the spigot <NUM>.

The valve closure members are seated on annular valve seats (not shown) defined inside the valve housings <NUM>, <NUM>. The valve seats are resiliently deformable and are generally located in respective recesses for receipt of the seat which, in use, is adapted to engage against a solid portion of the valve housings <NUM>, <NUM>.

The valve closure members are adapted to be pivotable through <NUM>° or beyond, thus when in its fully open position the profile of the face of the valve closure members corresponds with the profile of the through bore of the valve housings <NUM>, <NUM>, and thereby provides minimalrestrictions for the flow of fluid or other material.

<FIG> and <FIG> also show that the two valve portions <NUM>, <NUM> of the split valve assembly <NUM> are able to be locked and unlocked via rotation of a handle <NUM>. This can only occur when the split valve assembly <NUM> is in a closed configuration.

The two valve portions <NUM>, <NUM> of the split valve assembly <NUM> are mountable on a vessel (not shown) for containing material, conveyance means, such as a hose, for conveying material and/or other process equipment known to the art. The means for mounting the valve portions may comprise any means known to the art, such as for example a screw thread, interference fit, bayonet attachment etc. Alternatively, the valve portions <NUM>, <NUM> may be integrally formed with a vessel or conveyance means.

Whilst the foregoing describes how the present invention can be embodied in a valve-actuating handle <NUM> for manual operation of a valve or coupling, and particularly a split butterfly valve assembly <NUM>, the skilled person will appreciate that the invention can be implemented in any manner of transfer valve or coupling, such as, for example, split sliding gate valves, split ball valves, twin valves, rapid transfer ports and alpha beta ports.

<FIG> is a schematic diagram showing how the system and method for providing opening and/or closing feedback to an operator of a valve or coupling is implemented in a small, self-powered unit that includes a low power microcontroller <NUM>. As shown in <FIG>, the microcontroller <NUM> receives a number of inputs generally indicated in the right hand side of this figure.

The microcontroller <NUM> can be considered a self-contained system with a processor, memory and peripherals and can be used to provide opening and/or closing feedback to the operator via a number of outputs generally indicated in the left hand side of this figure.

<FIG> is a schematic diagram and, in order to aid clarification, many other circuit elements are not shown. For example, although not shown in <FIG>, the analogue signal received from one or more environmental sensors <NUM> embedded on the printer circuit board <NUM> is first converted to a digital form by any suitable type of analogue-to-digital convertor (ADC) available in the art. Equally, one or more of the digital outputs of the microprocessor <NUM> can be converted to analogue form using any form of digital-to-analogue convertor (DAC) available in the art. For example, such an analogue output signal could be used to energise an audible output <NUM>.

In operation, a set of instructions or algorithm written in software in the microcontroller <NUM> are configured to program the microcontroller <NUM>. The microcontroller <NUM>, including the processor, memory and peripherals, are firstly placed in a low power, standby mode, awaiting a wake-up signal. The wake-up signal can be received from the user input buttons <NUM> and/or from one or more environmental sensors <NUM> embedded on the printer circuit board <NUM> and/or from one or more equipment sensors <NUM>. In its most basic mode of operation, the microcontroller <NUM> can be effectively woken-up from standby mode by the operator pressing the on/off or standby button <NUM> located on the screen sub-assembly <NUM>.

In addition or alternatively, the microcontroller <NUM> could effectively be woken-up from low power standby mode by the operator simply grasping the handle shaft <NUM> or knob <NUM>. In a preferred embodiment, one of the equipment sensors <NUM> located on the printed circuit board <NUM> is a positional sensor which senses the rotational position of the handle <NUM> relative to the split valve assembly <NUM>. In use, the positional sensor is a three-axis accelerometer, and which is receptive to small input stimuli including rotation, pulse, shock, impact and/or vibration to firstly awaken the microcontroller <NUM>.

When the microcontroller <NUM> has been woken-up, it then senses the output of the three-axis accelerometer to determine the orientation and position of the rotation of the valve-actuating handle <NUM>. Since the position of the valve-actuating handle <NUM> controls the position of the pivotally-mounted valve closure members inside the split valve assembly <NUM>, the microcontroller <NUM> is able to determine the position of the pivotally-mounted valve closure members inside the split valve assembly <NUM> in real-time or near real-time.

In a basic mode of operation, the LCD display <NUM> can be used to display actions, movements or commands to the user, e.g. by displaying the words "OPEN" or "CLOSE". In addition, or alternatively, as opposed to displaying actions, movements or commands to the user, the state of the valve can be displayed. For example, the display <NUM> would indicate that the valve closure members are fully open by displaying the word "OPENED" or "<NUM>°", or simply displaying a green screen. Equally, if the microcontroller <NUM> determines that the pivotally-mounted valve closure members are fully-closed against their respective valve seats, the display <NUM> would indicate that word "CLOSED" or "<NUM>°", or simply display a red screen.

For detection of position of the valve closure members between fully-open and fully-closed, the angle between <NUM>° and <NUM>° or beyond is displayed, if the valve closure members are operated using an "over-rotation" method of cleaning the valve closure members and/or valve seats (as described in the applicant's published application <CIT>) is employed. Equally a percentage representative of the position of the valve closure members, between fully-open and fully-closed, can be displayed. For example, the display would indicate "<NUM>%" if the valve closure members are fully-open, and "<NUM>%" if fully-closed, and other percentages displayed for the sensed angles therebetween.

In a preferred embodiment of the invention, the position of the valve closure members relative to some predetermined or recommended opening or closing profile of the valve assembly is sensed, and at least one operator feedback signal is outputted based on the comparison.

The skilled person will appreciate that when operating the valve assembly <NUM> for controlling, charging, discharging and/or regulating the flow of liquids, slurries, tablets and/or hazardous fluids and potentially life-threatening pharmaceutical dusts and powders, it is imperative that a good seal is made between the valve closure member and the valve seat on each of the valve portions <NUM>, <NUM>. This is achieved, in practice, by operating the valve assembly according to a predetermined or recommended opening and/or closing profile, which is written in software in the microcontroller <NUM>.

The predetermined or recommended opening and/or closing condition or event can involve, for example, fully closing or opening the valve closure member over a certain timescale, e.g. <NUM> seconds, or closing the valve closure member to a certain predetermined first angle then opening the valve closure member to a second angle before fully-closing the valve closure member. This operation has the effect of removing excess powder from the valve closure members. Equally, performing an over-rotation of the valve closure member beyond <NUM>° with respect to the plane of the valve seat can help to ensure that a good seal is made. The over-rotation beyond <NUM>° allows the valve closure member to scrape off any residual material, such as powder, that may be disposed at the sealing surface of the valve seat to ensure that when the valve closure member is subsequently in its closed configuration, perpendicular to the valve seat, there is a good seal therebetween. Further detail of performing an over-rotation of the valve closure member beyond <NUM>° can be found in the applicant's earlier publication <CIT>.

Split valve assemblies <NUM> can be sterilised or decontaminated via a number of known methods, which include autoclaving, passing steam through the open valve, or passing other gases, such as vapourised hydrogen peroxide, through them prior to any pharmaceutical product coming into contact with the internal surfaces or product contact parts. Such Steam-In-Place (SIP) sterilisation often necessitates a predetermined or recommended opening and/or closing condition or event of the valve.

The skilled person will appreciate that the operator could initiate an optimised or recommended opening or closing profile by firstly selecting an appropriate user input button <NUM>, for example, by selecting a simple open, close or SIP. The microcontroller <NUM> then compares the sensed rotational position of the valve closure member in real-time or near real-time relative to the recommended opening or closing condition or event of the valve. The microcontroller <NUM> then outputs at least one operator feedback signal based on this comparison. The operator feedback signal can include one or any combination of, output signals to the visual display unit <NUM>, an audible output or alarm <NUM> or some form of haptic feedback <NUM>.

In one embodiment, as the user closes or opens the valve, a simple traffic light mode is employed whereby if the valve-actuating handle <NUM> is rotated at or near the recommended opening or closing condition or event of the valve, then the at least one operator feedback signal might be to illuminate the display <NUM> as green. If the operator closes the valve either too fast or too slowly, the display <NUM> will shift to orange or red indicating to the operator that valve is being operated incorrectly or carelessly.

In combination with these visual colour signals, various terms could be displayed to the operator, such as, "SLOW DOWN", "SPEED UP", "CORRECT" etc. An audible output <NUM> or alarm signal can also be used where the pitch or volume changes to indicate the comparison between the sensed rotational position of the valve closure member relative to the recommended opening or closing condition or event of the valve. Haptic feedback <NUM>, e.g. vibration transmitted through the handle <NUM>, can also be used to indicate to the operator that the valve-actuating handle <NUM> is being rotated at or near the recommended opening or closing condition or event of the valve.

As well as the microcontroller <NUM> outputting at least one operator feedback signal based on the comparison between the sensed rotational position of the valve closure member relative to the recommended opening or closing condition or event of the valve, it is envisaged that this information can be stored in local memory for analysis. This feedback information can be accessed locally and/or transmitted back to a central server (not shown) using a communications unit <NUM> which may be a suitable wired or wireless communication protocol, including for example, Bluetooth, ZigBee, or over a cellular network.

It is also envisaged that the microcontroller <NUM> could also include or has embedded therein a GPS location module <NUM> which records the actual location of the valve assembly <NUM>, along with other environmental sensors which record conditions such as external/internal temperature, light intensity, humidity, atmospheric pressure, force measurement and operation time <NUM>. These parameters can be stored in local memory and transmitted back to a central server (not shown) using the communications unit <NUM>.

It is desirable that the wireless network has low power consumption, enabling several years of operation between battery changes.

As an alternative to the wireless network described hereinbefore, transmission of the data may occur over a WiFi network.

Also by measuring the environmental condition of the valve assembly <NUM>, for example, if it was subject to excessive vibration or impact, pressure from the process, solvents, excessive forces from surrounding equipment etc., then such information can also be used, with the operator feedback to predict and prevent critical failure or unplanned maintenance.

Claim 1:
A valve or coupling comprising an apparatus for providing operator feedback in response to opening or closing of a valve or coupling, further comprising:
data storage means for storing at least one recommended opening or closing event of the valve;
sensing means for sensing operator actuation of the valve or coupling; and processing means for comparing the sensed actuation of the valve or coupling against the recommended opening or closing event of the valve or coupling in real-time or near real-time, and outputting at least one operator feedback signal based on the comparison;
wherein the sensing means for sensing operator actuation of the valve or coupling is positioned on an actuator;
wherein the actuator comprises an elongate handle having an elongate shaft with one end of the shaft being dimensioned to form a knob; the other end of the shaft being dimensioned to form a central hub comprising a first face for connection to the valve or coupling and an opposite second face that is visible to the operator; and
wherein the sensing means for sensing operator actuation of the valve or coupling senses the rotational position of a valve closure member relative to a valve housing.