WO2020094906A1 - Dispositif de manipulation de médicaments dangereux - Google Patents

Dispositif de manipulation de médicaments dangereux Download PDF

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Publication number
WO2020094906A1
WO2020094906A1 PCT/ES2019/070762 ES2019070762W WO2020094906A1 WO 2020094906 A1 WO2020094906 A1 WO 2020094906A1 ES 2019070762 W ES2019070762 W ES 2019070762W WO 2020094906 A1 WO2020094906 A1 WO 2020094906A1
Authority
WO
WIPO (PCT)
Prior art keywords
handling
dangerous
chassis
medicines according
control means
Prior art date
Application number
PCT/ES2019/070762
Other languages
English (en)
Spanish (es)
Inventor
Sergio Giménez Miralles
Luis Miguel Sabater Climent
Sandra Sabater Escuder
Ana Cristina Cercós Lletí
Original Assignee
Hospifar, Sl
Fundación Para El Fomento De La Investigación Sanitaria Biomédica De La Comunitat Valencia (Fisabio)
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hospifar, Sl, Fundación Para El Fomento De La Investigación Sanitaria Biomédica De La Comunitat Valencia (Fisabio) filed Critical Hospifar, Sl
Publication of WO2020094906A1 publication Critical patent/WO2020094906A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
    • B25J21/00—Chambers provided with manipulation devices
    • B25J21/02—Glove-boxes, i.e. chambers in which manipulations are performed by the human hands in gloves built into the chamber walls; Gloves therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30—Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/10—Filling containers or receptacles progressively or in stages by introducing successive articles, or layers of articles

Definitions

  • the purpose of this report is a device for handling dangerous and / or non-dangerous drugs, consisting of a chassis as an isolation booth that has high-efficiency filtration media (HEPA, High Efficiency Particle Arrestance, for its initials in English), preferably designed for coupling to the medicine packaging systems of hospitals, pharmacies, clinics, laboratories or the like; and whose main distinctive advantage lies in protecting during the handling of dangerous drugs in the handling and "repackaging" process, avoiding exposure of personnel during dose preparation operations, and thus, ensuring the protection of the health of the itself, the medicine (avoiding possible contamination of the same and / or cross-contamination with other medicines of various types) and the environment (treating the excess contaminants in a safe and certified manner).
  • HEPA High Efficiency Particle Arrestance
  • angerous drugs are those drugs that present a chemical risk to the personnel handling it, specifically, related to carcinogenic, teratogenic, genotoxic and toxic activity on the reproductive process or on a specific organ at low doses, or because it is a new drug similar to another with these types of risks, and among which are (among others) chemotherapy drugs, antivirals, hormones, drugs targeted by bioengineering, etc.
  • the operator or user in charge of said operation must (manually) separate the medication from the multidose or bulk format and adapt it for each case, which inevitably exposes the operator to harmful particles (in many cases with imperceptible densities for the user himself).
  • the applicants are aware of the existence of a multitude of machines for the packaging of drugs, which do not protect the operator during the handling of the same, which does not prevent contamination of the drug (and the patient), the manipulator and the environment.
  • the air expelled from the device free of contaminating particles allows the equipment to be placed on close or shared work surfaces, since it does not need coupling with extractor equipment to the outside; its portability allows it to be independent of the technical requirements of the area where it is located.
  • the ergonomic design of the device does not guarantee occupational risks derived from the posture and repetitive task in the medication packaging process, so guaranteeing ergonomic risk is contemplated in the design of the equipment regarding the manipulator.
  • the placement of the device with respect to the manipulator operator, regarding its inclination allows a line of sight with respect to the horizontal of the work area, providing the maximum guarantees for the prevention of occupational risks.
  • the invention presented here easily solves all the technical problems discussed above, since it provides a safe working environment where to handle medications, and is capable of joining on any packaging machine, shortening handling times. and packaging of medicines, and in turn, optimizing hospital resources, since it does not require more space than is already being used (it will only require the space already occupied by the packaging machine, since it will be placed on said machine).
  • the technical problem solved by the present invention is to obtain a ventilated device or cabin to handle dangerous and / or non-dangerous medicines, which allows its users to work safely (in accordance with current regulations) and which has a filtering system that eliminates the possibility of evacuating or extracting dangerous particles outside that can be inhaled by health workers and / or contaminate the environment.
  • the device for the manipulation of dangerous medicines object of the present utility model, is characterized in that it comprises a metal chassis with a prismatic shape, which has separate holes for the insertion of the operator's arms. These holes are located insofar as they allow maintaining an elevation of the arms with respect to the trunk and a flexion of the elbows and wrists that are compatible with the risk protection recommendations for posture and repetitive tasks.
  • the holes are connected to a central recess enabled as a work area that has a small cavity through which the drug transits to the area enabled for receipt in a drug packaging machine, and where the chassis in its front-upper part incorporates a window that allows the visualization of the tasks carried out.
  • the chassis incorporates a hole in which a pre-filter in charge of filtering the largest particles is housed in solidarity; and where associated with said pre-filter is a body comprising at least a first HEPA filter connected to an extraction motor that drives the aspiration of the contents of the work area, which is finally associated, with a second HEPA filter; all this commanded by a logical means of control.
  • the device presented here will ensure the containment of dangerous medicines inside the chassis that makes up the device's cabin, during the time of preparing the dose (before packaging). In this way, the exposure of the personnel authorized for such operations (hospital pharmacy operators, or any personnel authorized for this type of manipulation) to contaminating agents and dangerous to their health will be avoided, respecting the protocols and conditions necessary for a way of working. sure.
  • the ventilation and air filtration system will allow the extracted air to be free of contaminants, being able to be eliminated in the same area as the work area or outside it.
  • the device presented here may be used in other technical fields, such as microbiology or the like, where a safe work environment capable of filtering and vacuuming is required. low-size particles, in a simple and safe way; in such a way that all the work protocols in this technical field are respected, together with the specific regulations on the prevention of occupational risks, providing a safe working environment for the operator.
  • the device recommended here will be able to guarantee efficiency during its use, thanks to the presence of control and / or operation supervision systems, implemented in the electronic control means that command said device.
  • the device will only require an electrical connection for its operation, which will make its use more versatile, being able to be installed in any room where it can be enabled with the packaging machine, since its design and the different safety elements (will avoid possible cross contamination about the medicine).
  • Figure 1 shows a front view of the device for handling dangerous drugs, object of the present specification.
  • Figure 2 shows a perspective view of the device for handling dangerous drugs.
  • Figure 3 shows a schematic view of the forming elements of the device recommended here.
  • Figure 4 shows a first plan view of the chassis (1) as part of the device for handling dangerous drugs.
  • FIG. 5 shows a second view of the chassis (1) as part of the device for handling dangerous drugs.
  • Figure 6 shows a third view of the chassis (1) as part of the device for handling dangerous drugs.
  • the device for the manipulation of dangerous medicines object of the present memory
  • the device for the manipulation of dangerous medicines is characterized in that it comprises a metal chassis (1) with a prismatic shape, which has separate holes (1a) for the insertion of the arms of the operator destined to work , and that they are connected to a central recess enabled as a work area (1 b).
  • the holes (1a) will incorporate adjustment means, which allow their diameter to be adjusted to the diameter of the arm of the operator in charge of the operation.
  • the work area (1 b) will have a small cavity (1d) through which the medicine will transit to the area enabled for its reception in a medicine packaging machine. During use, the cavity (1d) may be covered during the preparation of the compound.
  • the chassis (1) on its front incorporates a window (2) preferably made of methacrylate, laminated safety glass or other material with equivalent mechanical characteristics; and it incorporates at least one closure (2a) that provides easier access to its interior, especially for those drug containers with large capacity, which will later be handled and repackaged; and in turn, prevents its opening until the end of the air renewal process.
  • the window (2) in a preferred embodiment, will have an opening range of up to 180 °, its preferred opening measure being 180 °.
  • the window (2) incorporates at least one closure (2a) which may be an electronic closure, an electromechanical closure or any equivalent closing means.
  • the chassis (1) will be made of stainless steel with polished corners or another material with equivalent mechanical characteristics; and presents inside, a spill tray also made of stainless steel or other material with equivalent mechanical characteristics.
  • the chassis (1) incorporates a hollow (1 c) where a pre-filter (3) is jointly housed in charge of filtering the largest particles; and where associated with said pre-filter (3) is a body (4) that comprises at least a first HEPA filter (4a) that is finally associated, with a second HEPA filter (4c), connected to an extraction motor (4b ) that activates the aspiration of the contents of the work area (1 b).
  • the body (4) will in turn house logical control means (5), which comprise at least a microcontroller or a PLC in charge of managing and operating the device, and where, among other functions, will be in charge of enabling the on and / or off of both the device itself, control over the lighting means, blocking, cleaning cycles, etc .; and where in addition, said logical control means (5) will comprise a plurality of sensors that determine pressure; air flow, hours of use; scheduled alarms; extractor operating status; electronic window opening lock (2) or the like.
  • the electronic control means (5) will incorporate a sensor that determines the speed of the extraction flow. In another particular embodiment, the speed will be determined in the extraction motor itself (4b).
  • the electronic control means (5) will be programmed in such a way that they control the ventilation and hours of use of the device, and in this way, control and / or guarantee the operation of the device, even in the presence of the effects caused due to the progressive obstruction of the HEPA filters (4a, 4c).
  • the logical control means (5) will be integrated in the logical means of control of a medicine packaging machine, connected and / or associated with the device described here.
  • the logical control means (5) will be operable either by means of a hand console or keypad with a display arranged on the external part of the body (4), or by means of a touch screen (6) attached or integrated into the chassis itself (1) of the device, or, by means of the action of the logical means of control of a packaging machine to which it is connected and / or associated.
  • the two HEPA filters (4a, 4c) are located in-line and are of the H14 type with 99.995% MPPS efficiency.
  • the extraction motor (4b) is a centrifugal motor or a motor with equivalent mechanical characteristics.
  • the chassis (1) will house lighting means on the work surface, using lamps.
  • the chassis (1) will be connected and / or attached to a data display screen (7), where the medicine data can be displayed, so that it can later be printed as a label for the medicine packaged by a machine packaging machine attached and / or connected to the device presented here.

Abstract

L'invention concerne un dispositif de manipulation de médicaments dangereux qui comprend un châssis métallique (1) dont chacun des orifices (1a) est relié à un trou central aménagé en zone de travail (1b) qui dispose d'une petite cavité (1d) par laquelle transite le médicament vers la zone aménagée en vue de sa réception dans une machine de conditionnement des médicaments, et dont le châssis (1) dans sa partie frontale comprend une fenêtre (2) et dans sa partie postérieure, un creux (1c) dans lequel est logé solidairement une préfiltre (3) chargé de filtrer les particules de plus grande taille; et qui est associé à un corps (4) qui comprend au moins un premier filtre HEPA (4a) relié à son tour à un second filtre HEPA (4c) relié à un moteur d'extraction (4b) qui actionne l'aspiration du contenu de la zone de travail (1b); tout ceci étant commandé par des moyens logiques de commande (5).
PCT/ES2019/070762 2018-11-08 2019-11-08 Dispositif de manipulation de médicaments dangereux WO2020094906A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201831719U ES1223000Y (es) 2018-11-08 2018-11-08 Dispositivo para la manipulacion de medicamentos peligrosos
ESU201831719 2018-11-08

Publications (1)

Publication Number Publication Date
WO2020094906A1 true WO2020094906A1 (fr) 2020-05-14

Family

ID=64960401

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2019/070762 WO2020094906A1 (fr) 2018-11-08 2019-11-08 Dispositif de manipulation de médicaments dangereux

Country Status (2)

Country Link
ES (1) ES1223000Y (fr)
WO (1) WO2020094906A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4108509A (en) * 1977-03-18 1978-08-22 Futurecraft Corporation Controlled environment work enclosure
GB2243800A (en) * 1990-05-07 1991-11-13 Hortotec A safety cabinet.
GB2286986A (en) * 1994-01-31 1995-09-06 Mdh Ltd Isolator and method of operating it
US20100044372A1 (en) * 2007-10-30 2010-02-25 Her Majesty The Queen in Right of Canada as Represented by the Minister of Public Safety Portable and collapsible chem./bio. isolators
GB2468657A (en) * 2009-03-17 2010-09-22 A1 Envirosciences Ltd Laboratory Containment Apparatus
US20120235548A1 (en) * 2011-03-16 2012-09-20 Intech Defense, Llc Methods and Systems For Providing Protection Against Harmful Materials
US20150072603A1 (en) * 2012-03-30 2015-03-12 Oxford Optronix Limited Controlled Atmosphere Workstation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4108509A (en) * 1977-03-18 1978-08-22 Futurecraft Corporation Controlled environment work enclosure
GB2243800A (en) * 1990-05-07 1991-11-13 Hortotec A safety cabinet.
GB2286986A (en) * 1994-01-31 1995-09-06 Mdh Ltd Isolator and method of operating it
US20100044372A1 (en) * 2007-10-30 2010-02-25 Her Majesty The Queen in Right of Canada as Represented by the Minister of Public Safety Portable and collapsible chem./bio. isolators
GB2468657A (en) * 2009-03-17 2010-09-22 A1 Envirosciences Ltd Laboratory Containment Apparatus
US20120235548A1 (en) * 2011-03-16 2012-09-20 Intech Defense, Llc Methods and Systems For Providing Protection Against Harmful Materials
US20150072603A1 (en) * 2012-03-30 2015-03-12 Oxford Optronix Limited Controlled Atmosphere Workstation

Also Published As

Publication number Publication date
ES1223000U (es) 2019-01-15
ES1223000Y (es) 2019-04-09

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