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Title:
PHARMACEUTICAL CONTAINER
Document Type and Number:
WIPO Patent Application WO/1995/001920
Kind Code:
A1
Abstract:
A container (20) for pharmaceutical products, in multiple discrete elemental form, such as tablets or capsules, has an overall "flat-pack" form, with a rectangular profile in elevation and plan, and a flip-top lid (22) lockable upon a body (21) by a rotary latch (37, 38); the rectangular profile assists manual operation and the lid is hinged from one extremity to facilitate opening by prising up the opposite free end; the lid may only be locked and unlocked when rotated into one of four quadrant positions at which the latch elements are aligned for disengagement.

Inventors:
BURSTON DALLAS (GB)
Application Number:
PCT/GB1994/001490
Publication Date:
January 19, 1995
Filing Date:
July 08, 1994
Export Citation:
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Assignee:
DALLAS BURSTON ASHBOURNE LTD (GB)
BURSTON DALLAS (GB)
International Classes:
B65D50/06; (IPC1-7): B65D55/02
Foreign References:
US4449639A1984-05-22
AT304290B1972-12-27
EP0110796A11984-06-13
GB1520808A1978-08-09
EP0500265A11992-08-26
EP0541846A11993-05-19
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Claims:
Claims
1. A container, for example for pharmaceuticals, comprising a body a fliptop lid or sealing closure cap mounted upon the body for rotary locking action therewith, the container lid and body sharing a complementary rectangular profile, both in plan and side elevation. II. A container of generally polygonal (ie multiple, individually flatsided) crosssection, incorporating a body housing an internal storage region or enclosure, with an access aperture to the contents thereof, a relatively movable combination rotary locking unlocking and liftoff or 'fliptop' lid or sealing closure cap for the access aperture, the lid and body being mutually entrained by a rotary latch mechanism. A pharmaceutical pill, tablet or capsule container comprising a body and relatively latchable closure lid, of generally complementary polygonal eg rectangular crosssectional profile either or both in elevation or in plan. IV. A tamperresistant pharmaceutical container comprising a hollow, general rectangular, body defining a storage region for pharmaceutical tablets, capsules or the like, an access aperture at one end of the container for example upon an upstanding neck, a lid of complementary profile to the body and forming a closure for the access aperture, the lid and body being provided with complementary thread elements which, when interengaged/threaded together, effectively lock the lid upon the container and deny/inhibit access to the access aperture and thus the container contents. A container substantially as hereinbefore described with reference to, and as shown in, the accompanying drawings.
Description:
Pharmaceutical Container

This invention relates to containers and is particularly, but not exclusively, concerned with containers incorporating a facility for dispensing the container contents in a controlled incremental discharge.

The term 'containei' is used herein to embrace any form of enclosure or hollow vessel, for storage purposes - whether with or without any controlled discharge or dispensing features. Similarly, the term 'dispense/' is used herein to embrace any device or contrivance for the controlled egress, discharger or re-disposition of contents from an enclosure or vessel, such as a container.

Thus an integrated container and dispenser may typically combine an enclosure with a controlled access device, whereby the container contents may be disgorged or output progressively in some manner to a greater or lesser degree controlled - and even predetermined, eg in a 'one-shot' dispenser.

Pharmaceutical containers may fulfil the role of pharmaceutical product dispensers.

A diversity of containers have been used for pharmaceutical products - for example, in multiple, discrete, solid element form, specifically, tablets or capsules.

Typically, a generally cylindrical profile has been adopted for pharmaceutical containers, with a removable, 'lift-off' cap.

It is also known - particularly with the storage of products for human consumption - to provide a container with some form of tamper evident indication. Typically, this is by means of a peripheral annular sealing strip or ring with an end pull- tab, initially bonded to, or otherwise integrated with, the cap and container.

The tab must be physically removed (by pulling and severing) to enable operation of the cap.

This very locking tab removal provides a visual indication that access has been attempted.

The strip may also provide additional security, or entry deterrent - inhibiting dislodgement of the cap, for example upon casual impact or contact.

The strip may also afford a supplementary (external) seal for the container - for example in addition to any sealing provision between the cap (inner) and the container (outer) contact surfaces.

It is also know to incorporate so-called 'child resistant' closures to containers - whose (mechanical) function is (supposedly) difficult for a child to fathom or understand and thus operate correctly, in order to gain access to the container contents.

Such child resistance may, for example, comprise a supplementary 'interlock' between the container body and cap, which must be over-ridden or 'unlocked' before prising the cap from the body. The interlock may utilise an interactive threaded coupling, such as a bayonet pin and socket, holding the cap 'captive' to the body, but allowing free relative rotation, and requiring a certain cap and body pre-alignment to disengage the cap and body threads.

Indeed, regulatory constraints may require provision of both tamper evident and child proof/resistant container packaging for certain 'sensitive' products such as pharmaceuticals - whose unsanctioned or unsupervised consumption may have adverse, or even fatal, health consequences.

However, in practice, child resistant features may not prove a deterrent to a determined inquisitive child, without conventional mechanical pre-conceptions of what means might be tried to remove the cap. Indeed, they may even represent a challenge.

A disadvantage of some known containers and their various individual locking and security provisions is that their implementation or operation may require more grip, dexterity or force, than, say, a frail, elderly or infirm person can effectively expend or deploy. This can represent a deterrent to an intended user.

For example, simply gripping and rotating the cap of a cylindrical container may defeat the patient user and prospective contents consumer - as would attempting to prise off the cap by overcoming the light' frictional interaction of the cap and body contact seals.

The profile and contact area available, aside from the movement action and effort required, are contributory factors. indeed it is a common experience that sudden removal of the cap, upon momentarily overcoming the seal resistance, can lead to uncontrolled spillage of the container contents. There may thus be a practical limit upon the seal efficacy, for example to moisture, which in turn undermines the long term storage capability of the container.

It is known to provide containers with a restricted access opening and even a controlled gateway, in order to regulate the dispensing of contents. However, this is difficult to achieve for a variety of container contents.

It is also necessary to fill the containers initially, and in mass production processes this may not be feasible through the access point for subsequently controlling discharge of the container contents.

According to one aspect of the invention there is provided a container comprising a hollow body enclosure defining a storage region - for example for pharmaceutical

products, such as those in multiple, discrete elemental form, ie tablets or capsules, a discharge access in the body, a lid or closure cap beatable over the body access to seal off the access, the closure cap being lockable to the body when located over the body access, by relative rotary movement of the cap and body, to selectively and alternatively hold the lid captive and release the lid for pivot movement about one end thereof, exposing the discharge access, to allow egress of the container contents.

According to another aspect of the invention there is provided a pharmaceutical product container comprising a flat-pack body surmounted by a combination rotary and lift-off lid or closure cap of complementary flat-pack profile.

There now follows a description of some particular embodiments of the invention, by way of example only, with reference to the accompanying diagrammatic and schematic drawings, in which:

Figure 1 shows a perspective view of a container with a top lid closed; Figure 2 shows a perspective view of the container of Figure 1 , with the top lid open;

Figure 3 shows a side end elevation of the container shown in Figure 1 ;

Figure 4 shows and opposite side end elevation to that shown in Figure 3;

Figure 5 shows a top (upper plan) view of the container shown in Figures 1 through 4;

Figure 6 shows a base (underside plan) view of the container shown in Figures 1 through 5;

Figure 7 shows a front face elevation of the container shown in Figures 1 through 6;

Figure 8 shows a rear face elevation of the container shown in Figures 1 through 7;

Figure 9 shows a scrap section of the lid and integral base neck mounting collar for the container of Figures 1 through 8 in alternative open/closed and assembled/pre- assembled conditions;

Figure 10 shows a top (upper plan) view of the body of the container shown in Figures 1 through 9, with the lid removed;

Figure 11 shows a sectional (side) view of the container shown in Figures 1 through 8, with the lid closed upon the body; and

Figure 12 shows an end section corresponding to side section of Figure 11.

Referring to the drawings, and in particular Figures 2, 9 and 11 , a container 20 is of generally rectangular profile, with a base or body 21 , surmounted by a hinged lid 21.

Surmounting the container body 21 is an upstanding cylindrical neck 28, with an access aperture 29 to the interior of the container 20. This is primarily used for discharging the container contents in a controlled manner, but may also be used for filling or replenishing in certain circumstances.

Around the periphery of the container neck 28 is a thread element 31, with a break or gap 37 to receive a thread running abutment or nose element 38 on the inside of the lid 22. Overall, the container 20 incorporates various significant features, including:

I. a generally rectangular profile - which facilitates grip, and affords a mechanical advantage when turning the container; II a side hinged (flip-top) lid - with a lateral lip which facilitates prising open the lid and provides attendant mechanical advantage;

III a tamper-resistant lid locking/unlocking security - requiring initial rotation of the lid to a prescribed position or orientation;

IV mutual entrainment of the lid and base - through a captive collar;

V end hinging or pivoting of the lid about a position remote from the container axis and opposite to lifting end - providing an attendant mechanical advantage in prising open the lid - particulary against the resistance of tight lid seals (this in turn allows for a more effective - ie tighter - seal; VI integral moulding of the lid and entrainment collar;

VII discrete base insert - enabling rapid container filling when inverted, before insertion of the base element; VIII base storage region - at the underside of the container bottom

or floor is a supplementary recess into which a multiple folded patient information leaflet may be inserted, restrained or entrained by a sprung clip, or even the resilience of the leaflet paper or card;

IX improved internal seal and thus moisture vapour transmission (MVT) inhibition performance (thus preserving the container contents against degradation), without attendant stiffness in lid removal; and

X multiple, eg double, layers or skins of lid promoting resistance to ultra violet (UV) light penetration (and thus again helping preserve the container contents against degradation). Dealing with these various aspects individually in turn:

Flip-Top Lid

The lid 22 is mounted as a 'flip-top' to the base 21 - that is it is hinged or pivoted, from one end extremity, with respect to the base 21.

The lid 22 and body 21 are mutually entrained - or held captive to one another - by a collar 39 and depending lateral arm 35 integrally moulded with the lid 22 and mounted around the upstanding neck 28 on the upper end of the body 21.

Figure 9 shows both the opened out and closed - and assembled and pre-assembled - conditions of the lid 22 and integrally moulded arm 35 and collar 39 about a mutually entraining reduced wall section, forming a hinge or pivot region 36. As depicted to the left hand side of Figure 9, the integrated lid 22 assembly is actually moulded in the opened out condition - which therefore also represents the 'relaxed' (open) condition of the lid 22 when mounted upon the upstanding neck 28 of the body 21. The lid 22 can thus be mounted upon the neck 28 of the body 21 in the opened out condition - and, in order to close the lid 22, the collar 39 and arm 35 are folded inwards about the waisted hinge region 36 and tucked inside the outer shell 51 , as indicated by arcuate arrow 61. In that 'tucked-under' condition, the lid collar 39 partially enshrouds the internal depending neck 33 - with the neck 28 of the body 21 intervening there-between, as shown in Figures 9, 11 and 12.

Closure of the lid upon the neck 28, requires it be folded against the natural resilience of the hinge 36 - and similarly, when the lid 22 is released from the neck 28 it has a natural tendency to spring open.

To the right hand side of Figure 9 is depicted the integrated moulding of the opposite end of the lid 22 from the mounting collar 39, to form an internal latching web 47 with a bayonet style latching element 38 for engaging (and thus locking) the lid 22 upon the

threads 32 of the neck 28, as shown more clearly in Figures 2 and 11.

In preliminary assembly of the lid 22, before mounting upon the neck 28 of the body 21 , the latching web 47 is first tucked under the outer shell of the lid 22, by folding inwards as indicated by arcuate arrow 62, and latched upon an internal projection 49 on the underside of the lid shell 51.

To assist in removal of the lid 22 - eg single-handedly - one end thereof may incorporate an integrally - moulded finger/thumb recess (not shown).

Practicalities

There is a natural (geometric) tendency for multiple discrete components - for example pharmaceutical product tablets or capsules - to nest together in bulk. In doing so, they may adopt an orientation which inhibits their passage towards and through the access aperture 29.

Put more simply, discrete elements may jam together in the neck 28 and may prove difficult to dislodge - encouraging the user to shake, strike or vibrate the container 20 in an attempt to re-orientate and re-dispose the elements. Even if this 'informal- empirical' tactic works, there is a tendency for the contents to disgorge suddenly in an uncontrolled outflow.

The cross-sectional shape of the access aperture 29 and the axial extent of the neck 28 and the degree of taper of the shoulders 27 are selected to promote a controlled release, discharge or passage of the container contents.

Additionally, the body volume capacity is greater (but not unduly) than that of the maximum intended contents - that is there remains a predetermined minimum free 'head-space' above the contents, even when the container is full.

Such a head-space allows free re-disposition of the contents and thus the opportunity for individual elements to separate from the inter-nested bulk. Nevertheless, in order to restrain such contents movement and thus obviate any consequential damage (eg tablet chipping or fragmentation), during initial packing and transit, a resilient foam packing element or plug may be inserted after filing.

Lid Seal

A multiple sealing arrangement is associated with the inter-fitting lid 22 and neck 28 profiles.

Thus a seal may be effected between the top edge of the neck 28 and the inner face of the lid 22 (ie the underside of the shell 51) - although the contact region is a marginal (annular) peripheral one.

The effectiveness, if any, of such a seal, depends upon the downward clamping force exerted between the lid 22 and body 21 , upon the rotary inter-locking action described elsewhere.

Additionally, the interior of the lid 22 incorporates a depending seal collar 33 with an external peripheral protruding annular seal rim 34, which inter-fits with a complementary profiled groove 31 on the internal circumference of the upper end of the neck 28 of the body 21 when the lid is in place - as depicted in Figures 11 and 12.

Such a seal relies upon a radially tight inter-fitting of lid collar 33 and the body neck 28 - which is independent of the degree of clamping or locking of the lid 22 upon the body 21, but which extends over a larger mutual surface contact area then, say, the neck rim seal.

Overall, the multiple inter-engaging contours promote a secure, tight inter-fitting seal action - without requiring the lid 22 to fit unduly tightly, ie to the extent of inhibiting lid 22 separation and removal. The wall thickness and material are selected to afford the necessary rigidity or semi- rigidity and resilient deformability, according the local requirements.

Lid Tamper Resistant Lock As depicted in Figure 10, the upper end of the neck 28 of the body 21 incorporates a diametrically- opposed pair of recesses or gaps 37 in the outer circumferential thread 32, which allows introduction and removal of a thread running element 38 within the lid 22. Thus only at (two Opposed' sets of two - ie four) discrete equi-angulariy-spaced relative positions of the lid 22 and body 21 can the lid thread running element 38 be engaged within or disengaged form the thread 32 of the body 22.

At these 'quadrant' positions the lid may be opened or closed.

It follows that, if the lid 22 is closed it cannot be opened until it is correctly aligned in the quadrant - and nor similarly, if the lid 22 is already open, it cannot be closed until that quadrant alignment is achieved. The four quadrant alignment conditions - or relative lid 22 and body 21 positions - represent the lid 22 at right angles to the body 21.

Thus, with the lid 22 aligned with the body 21 and the respective thread runner 38 and thread 32 inter-engaged, the lid 22 is effectively locked closed - and cannot be opened until it has been turned relative to the body 22 fairly precisely through 90 degrees, or at right angles thereto.

In order to assist in relative alignment of the lid 22 and body 21 for lid unlocking- opening and closing-locking, an internal mechanical 'user feel' position indexing facility is provided.

Specifically, the lower end of the neck 28 of the body 21 at the region embraced by the collar 39 or neck band of the lid 21, incorporates a series of (in this case 4) equi- angulariy-spaced index protrusions 53, which are receivable in a corresponding (but unshown) array of recesses in the internal face of the collar 39.

In this way, relative rotation of the collar 39 upon and about the neck 28 is alternately free and detented or detained by the location of the index protrusions 53 in the index recesses, requiring modest force to displace, but affording a relative angular position reference between the lid 22 and body 21.

This in turn enables the user with the requisite preliminary knowledge fairly readily to achieve the lid and body alignment necessary for operation of the container 20 by 'feel' - without the exercise of undue skill or dexterity. This is important for the elderly, frail or infirm.

Nevertheless, the 'secret' or concealed/disguised internal indexing is not readily fathomed by children - and thus some of degree tamper resistance is achieved.

A supplementary visual indication - for example markings (such as moulded arrow heads) on the lid and body which must be brought into alignment - may also be provided to facilitate the lid unlocking and locking actions.

Collar Mounting and Retention In order to mount the lid 22 upon the neck 28 of the body 22, the retaining collar 39 must be located and pressed downwardly over the neck 28, until it reaches the lower shoulder 47 of the neck 28 to which its internal profile 46 is complementary, providing a snug, but relatively rotatable fit. Removal of the collar 39 is inhibited by inter-engagement of a wedge profile internal shoulder 44 at the upper end of thereof (as more readily appreciated from Figure 9) with a complementary wedge shoulder at the mid-section external periphery of the neck 28. In this way, the collar 39, and thus the integral arm 35 and remainder of the hinged lid

22 is entrained upon the neck 28 of the body 21 , but remains freely rotatable thereupon - to enable locking and unlocking of the lid, as described previously.

Rectangular Ergonomic (body) Profile

The rectangular profile, particularly the cross-section more readily apparent from Figures 5, 6, and 10, lends itself more readily to handling, than, say a conventional cylindrical barrel container. Specifically, the rectangular body 21 is more ergonomic to grip when seeking to remove the lid 22 - by a relative twisting or turning action. Thus the extended radial profile of the body 21 about the container twist axis provides greater turning moment or leverage about the container axis. Similarly, and as more readily appreciated from Figures 2, 5, 6 and 10, in order to obviate shaφ transitional edges and provided a more 'user-friendly' or sympathetic profile, the side walls the container body contours are embody a shallow curve with progressively more rounding towards the comers. Such corner rounding also features on upper edges of the lid 21.

Capacity Variation

The same cross-sectional size and shape lid and body configuration may readily be employed for bodies of different length - ie shallow and deep - in order to achieve volumetric capacity variations.

In the case of pharmaceutical product containers, there is typically a requirement for a progressive range, typically three or four, containers with capacity for a specified number of tablets or capsules, each of a prescribed dosage, and collectively representing a treatment regime at a prescribed consumption rate. For example, a one or two week treatment at one tablet/capsule per day, may be held in a single container.

Packing & Stacking The generally rectangular overall profile of the container 20 lends itself to packing - ie one container nesting against another - without undue wasted space, particularly when compared with conventional cylindrical container configurations.

That is, rectangular profiles nest naturally together, with minimal inter-pack voids.

Thus for distribution and transport, a tray of such containers may simply be shrink- wrapped in plastics film, and stacked in tiers with other such shrink-wrapped trays.

Moreover, aside from bulk storage, containers of such profile are more readily stored and displayed ready for filling or dispensing pre-filled upon the shelves of a pharmacist or dispenser.

Label - Identification Profile The relatively flat side surfaces of the container lend themselves to the application and display of (impersonal - supplier issued) product content and (personalised for the recipient) use label information.

Such information is a combination of pre-prepared (impersonal, product-specific) manufacturers' product identification, both brand and generic, and technical specification or formulation and product licence number, brand or trade mark and manufacturer or supplier's identity and address - together with (personalised, patient and product specific) prescription information personalised at the point of dispensing, typically with the name of the recipient patient, and consumption directions, ie number and frequency of tablets, produced at the point of issue or dispensing.

Thus pre-filled, sealed containers from the manufacturer can readily be identified by a large clear label area - assisting in minimising dispensing errors to the individual patient recipient.

Moreover, if the patient is under a regime of different medications, the distinctive container profile and prominent label identification area, assist in avoiding patient consumption errors - and promoting patient 'compliance' (ie taking only the medication prescribed, when appropriate and for a full course of treatment).

Storage Capacity for Given Container Size/Volume

The overall container configuration is volumetrically-efficient - that is the effective or usable storage capacity is a good proportion of the outer volume.

Filling

The container may be filled in production, either through the mouth 29, using proprietary filling/counting/weighing equipment, before the lid is fitted - or by inverting the container before the base element 41 is installed.

Even without the base 41 in situ, the lid assembly 22 may be mounted upon the body 21 , and indeed locked in position thereupon. Fabrication

The container 20 may be moulded from synthetic plastics materials, with appropriate characteristics, using conventional techniques. Thus the body 21 could be moulded from, say, white, high density polyethylene, the lid or closure cap from, say, white polypropylene and the base also of white polyethylene.

Tamper Evident Locking Security

As depicted in Figure 1 , the lid 22 and body 21 of the container 20 are initially sealed, entrained or tethered together - or simply mutually restrained (ie from relative rotation necessary to unlock the lid) - by a lateral locking strip 23 along one of the longer side walls.

This strip 23 may be integrally-moulded with the lid 22 with a pre-formed weakening line to facilitate subsequent separation and detachment.

The strip 23 may optionally incoφorate a thread blocking element which inhibits co- operative action of the threads on the lid 22 and neck 28 of the body 21.

The strip 23 may thus be present initially upon the lid 22 - which is installed by the initial moulding process, and before insertion of the base 41 , so that the lid 22 and body 21 are initially integrated by the strip 23.

In this way, the container 20 can be filled from the base end by upturning and the base 41 subsequently installed. In that regard, the base 41 is a one-way fit in the interior base periphery of the body 21 , with inter-engaging complementary detent ribs and recesses 42, 43.

In order to assist removal, one end of the locking strip has a slightly protruding end pull tab 24, whereby the strip 23 can be prised away from both the lid 22 and body 21 (and indeed separated altogether there-from and disposed of) - enabling relative (unlocking) rotation there-between, and thus access to the container contents, through the access aperture or mouth 29.

This strip 23 thus provides a form of tamper-evident seal - removal of, or even interference with, which provides a readily visible indication that the container contents may have be interfered with.

Such a tamper evident feature is primarily for peace-of-mind and security to the customer or recipient upon the initial presentation of the container 20.

Nevertheless, a lateral locking tab could in some form remain a permanent additional security feature, for example in child-resistance.

Dispensing

The dispensing - ie controlled discharge - capabilities of the container 20 may be enhanced, for example to include some form of quantity or flow regulation - and even measurement.

Thus the lid 22 could form an intermediary reception ladle - with the container contents first being disgorged by careful tipping over into the upturned inner crater or 'cradle' of the lid.

Such a lid cradle might be of a prescribed volume or capacity - so that when full, its contents represent a prescribed dosage (of a pharmaceutical container contents).

Dispensing control may feature more importantly with flowing bulk container ingredients - ie powders and liquids.

In such cases a valve assembly may be included - for example with the valve elements embodied in the lid and body (neck or spout) structures. The valve operation may rely upon the relative lid and body rotation previously described to open and close the valve, ie by aligning respective access apertures or tightening or releasing an intervening seal element - and indeed supplemental movements. OPD: One Pack Dispensing

A container according to the invention lend itself to OPD or One Pack Dispensing requirements. That is the container contents are self-contained as a complete course of treatment and thus can be dispensed as an entire intact - and (tamper evident) sealed - pack.

Thus the pharmacist or dispenser is not required to fill the container, but simply to allocate a pre-filled container from stock, using the external reference labels.

The scope for dispensing errors - eg wrong product or wrong amount - is thus considerably reduced.

Indeed the trend in pharmaceutical dispensing regulations is towards requiring OPD as a matter of routine.

Variations

It should be appreciated that the size, proportions and configuration of the container may vary considerably and may be adapted to suit particular purposes - ie contents nature, bulk storage capacity and dispensing or controlled discharge requirements.

Thus, although the example described is adapted for the containment and dispensing of multiple discrete solid product elements/items - in particular pharmaceutical tablets or capsules - similar constructional principles may be applied to a container and dispenser for liquids.

In such liquid vessels the lid or cap seals may be improved for security of liquid retention and the access opening reduced to facilitate a controlled outflow of liquid contents. Similarly, a funnel, mouth or spout may be provided - say, in the neck profile.

Whilst, in the embodiment described, the neck 28 is co-axial with the container - or the container axis of symmetry, a laterally- offset neck position could be adopted without undermining the flip-top leverage action, as indeed could non-symmetrical body profiles and lid/body relative configurations.

That is the lid and body do not have to conform identically in profile. For example, a deliberately enlarge lid could be provided to facilitate gripping and removal. Individual Roles of Lid and Body - other environments.

Although the lid and body have been hitherto described as a co-operative, integrated whole, they may fulfil separate, independent roles. That is to say a given lid could be mounted upon disparate containers, provided the immediate neck configuration remained in common.

Indeed the closure principle disclosed may be applied in disparate environments outside the conventional container art. For example, a sealing closure door for an appliance with an activity chamber, such as a washing machine may usefully embody the integrated flip-latch and turn-locking facilities disclosed.




 
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