EP1107913A1 - Method for external decontamination of a packaged object - Google Patents

Method for external decontamination of a packaged object

Info

Publication number
EP1107913A1
EP1107913A1 EP19990932926 EP99932926A EP1107913A1 EP 1107913 A1 EP1107913 A1 EP 1107913A1 EP 19990932926 EP19990932926 EP 19990932926 EP 99932926 A EP99932926 A EP 99932926A EP 1107913 A1 EP1107913 A1 EP 1107913A1
Authority
EP
European Patent Office
Prior art keywords
object
envelope
casing
decontamination
outer surface
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
EP19990932926
Other languages
German (de)
French (fr)
Other versions
EP1107913B1 (en
Inventor
Jean-Pierre Grimard
Jean-Yves Porret
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson France SA
Original Assignee
Becton Dickinson France SA
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
Priority to FR9810928 priority Critical
Priority to FR9810928A priority patent/FR2782644B1/en
Application filed by Becton Dickinson France SA filed Critical Becton Dickinson France SA
Priority to PCT/FR1999/001779 priority patent/WO2000012388A1/en
Publication of EP1107913A1 publication Critical patent/EP1107913A1/en
Application granted granted Critical
Publication of EP1107913B1 publication Critical patent/EP1107913B1/en
Application status is Active legal-status Critical
Anticipated expiration legal-status Critical

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages

Abstract

The invention concerns a method for the external decontamination of a packaged object (1), the latter comprising the object (2) proper whereof at least the external surface (2a) is in decontaminated state, for example sterile, a closed envelope (3) containing said object, whereof the inside (5) is in decontaminated state, for example sterile, as well as filtering means (4), said method comprising a step for decontaminating the envelope external surface (3a). The invention is characterised in that, before decontaminating the envelope external surface, it consists in: a) forming in the envelope (3) at least two parts (31) and (32) respectively defining two sections (51) and (52) sealed with respect to each other, one first part (31) containing said object (2), and a second part (32) comprising the entire filtering means (4); b) separating the second part (32) from the first part (31), while preserving the tightness of the first section (51); then subjecting only the first part (31) to the decontamination step of the envelope (3) external surface (3a).

Description

EXTERNAL DECONTAMINATION PROCESS OF PACKED SUBJECT

The invention relates to the external decontamination of a packaged object known in itself, particularly in the medical or pharmaceutical field. Generically, the packaged objects affected by the decontamination process according to the invention include: the object itself, at least the outer surface is at 1 'decontaminated state; - a sealed envelope containing said object, one inside is 1 'decontaminated state; and a filtering means providing a gas passage through the casing, but whose cutoff threshold is determined to stop the flow of contaminating agents to the interior of the envelope.

By "contamination" or "contamination" is meant any on or in an object, uncontrolled or controlled, characterized by the presence of any biological substance or biological origin, not desired, for example a pathogen, and / or any non-biological substance, for example the discrete state or in particulate form, capable of serving as carrier or support for said undesired biological substance.

As a result of the above definition, a contaminant of the invention comprises a biological substance and / or a non-biological substance, as defined above.

By "decontaminated" or "decontamination" means any limited or controlled level of contamination on or in an object.

By "sterile" or "sterility" is meant a level of decontamination characterized in particular by the statistical absence of any organic substance in or on an object. More particularly, but not exclusively, the present invention will now be introduced, defined and described below with reference to the medical or pharmaceutical field, for which it is often required to avoid or minimize contamination of biological origin coming from an external environment.

In this particular field, and referring to the business activity of the Applicant, it manufactures and sells packaged objects corresponding to the above generic definition, in that the object itself is eg a container closed or not, wherein is disposed a load consisting for example of a plurality of medical or pharmaceutical use components, namely syringe bodies to be filled with a medicament may be in various forms, and in particular in liquid form; this container is completely decontaminated, which is considered the outer surface, the inner surface, within said container, or the said load; but the object itself, to which the present invention may also consist of a single product for medical or pharmaceutical use; the envelope consists of a bag closed for example by welding, whose wall consists of a material such as a flexible thermoplastic material; inside this bag is in the decontaminated state, while the outer surface of the same bag remains contaminated, that is to say non-sterile; the filtering means consists for example of a piece of a particular material selected from a thermoplastic material in the non-woven condition, a coated paper, a woven material having microperforations; this piece is fixed to the bag material or shell, for example by heat-welding, sealing, gluing; this is filter means which allows the "breathing" of the packaged object, in that it ensures all gas passage to the interior or exterior of the casing, for example to carry out decontamination, and inside the envelope, outside the object itself or within the latter, in the case of a container itself provided with its own filter means; for example, the filter medium is a piece of material known under the trademark "TYVEK®", and sold by DuPont Company of Nemours; the inner face of the previously defined filter means remains also in the decontaminated state.

The previously exemplified packed object is used in practice to introduce the above components for medical or pharmaceutical use, for example syringe body from an external environment to and in a chamber at controlled atmosphere, wherein said components are unpacked and used or consumed , for example for mass-produce pre-filled with a drug syringes.

To this end, it is necessary beforehand to the external decontamination of the packaged object. Traditionally, it may for example be performed by passing the packaged object in a lock or decontamination tunnel, wherein the outer surface of the casing is exposed to a treatment decontaminant, such as irradiated with a sterilizing radiation, such an ultra-violet light. Such decontamination process is imperfect for various reasons, keeping essentially to the existence of the packaged object of the filtration means previously exemplified: as the filtering means consists of a piece attached and fixed on the material of the envelope itself, the seals thus obtained are in themselves "nests" of contamination, particularly difficult to treat by illumination with radiation decontaminant, ultraviolet example;

- the filter medium is in any case an opaque portion, which shadow on the rest of the casing opposes or affects the decontamination of the corresponding portion of said envelope; the filtering means retains in situ the contaminants (e.g., bacteria); and complete decontamination of said filtration means can not be ensured.

The present invention aims to remedy all these drawbacks.

The invention relates to an external decontamination method of a packaged object, residing compatible with the implementation of a filter means on the closed envelope, but allowing to overcome the latter during the external decontamination 1 envelope. According to the invention, before the decontamination step of the outer surface of said casing: a) forming in said at least two casing parts respectively determining two watertight compartments relative to each other, a first part containing the object itself, and a second part comprising the whole of the filtration means; b) separating the second portion of the first part of the casing, maintaining the tightness of the first compartment; then only submits the first portion in the step of decontamination of the external surface of the casing.

Therefore, according to the invention, the packaged object is fed into an intermediate conformation characteristic that the envelope is formed of at least two parts respectively defining two watertight compartments relative to each other, namely a first portion containing the object itself, and a second part comprising the whole of the filtration means.

The method according to 1 the invention provides a further unexpected advantage when the decontamination step of the outer surface of the envelope is effected, either by illumination of the packaged object with a decontaminating radiation but comprises a sterilization setting contacting the outer surface with a sterilizing gaseous medium, especially a sterilizing gas, for example ethylene oxide. Indeed, by difference with a packed object processed for example in the traditional way, the gaseous environment exerts its sterilizing action only on the outer surface of the casing, limited to the first previously defined portion, that is to say without the filtering means; in this way, the gaseous environment does not penetrate inside the flexible envelope, and optionally inside the object itself, which limits the sterilizing gas consumption on the one hand, and restricts the time of the other treatment, since in particular it is no longer necessary to evacuate the interior of the flexible bag and optionally the object itself. This also prevents the presence in the envelope and possibly the object of possible residues of the sterilizing gas.

Furthermore, still surprisingly, the intermediate conformation of the packaged object, characterizing the invention may be implemented in a completely different purpose, namely to obtain the same object in packaged form, but incorporating a tamper evident before unpacking. To this end, starting from the packaged object as defined above: a) is discharged from the inside of the casing the gas contained therein, or is filled with the inert gas, in particular in the decontaminated state, within said envelope; b) then formed in the wrapper at least two parts respectively defining two watertight compartments relative to each other, a first part containing the said object, and a second part comprising the whole of the filtration means; c) separating the second portion of the first part, preserving one seal of the first compartment; whereby the first part of the casing, evacuated or filled, demonstrates the integrity of the packaging of the packaged object.

Preferably, during step (a), surremplit with said inside gas of the casing (3), so as to inflate the latter.

The present invention is now described by way of example, with reference to the accompanying drawing, wherein: Figure 1 shows a perspective view of a packaged object, before carrying out the decontamination process according to one invention; - Figure 2 shows a perspective view of the same object, in its intermediate conformation, always during the decontamination process according to one invention; 3 shows, schematically, the various stages of decontamination process according to the invention, starting from a packaged object as shown in Figure 2; 4 shows the packaged object in its conformation immediately before the decontamination step. A packaged object 1, as processed according to the process of one invention comprises: the object 2 itself, at least the outer surface 2a is in the decontaminated state; - a casing 3 closed, contains the object 2, the interior of which is in the decontaminated state; this envelope may be obtained from a duct or from two sides of a flexible thermo-plastic material, welded for example by hot melting, high frequency fusion, ultrasonic fusion of said material along a line of determining welding in particular two gaskets 7 and 8 parallel and extremes; a filtering means 4 providing a gas passage through the housing 2, whose cutoff threshold is determined to stop the flow of contaminating agents to 1 * within one enclosure; as said above, it is for example a piece filling the casing 2, and fixed to one and / or both sides of said shell; by way of example, the filter means 4 is a part of a nonwoven of thermoplastic material, based on one of the sides of the envelope and heat-sealed on one side on the lower side (cf. Figure 1), and on the other side on the upper side along the line 8, as well as along its transverse edges.

The previously defined packaged object is shown on the left of Figure 3, before carrying out the process according to the invention which comprises the steps of: a) forming in the housing 3 at least two parts 31 and 32 determining respectively two sealed compartments 51 and 52 relative to each other, a first part 31 containing the object 2, and a second portion 32 containing all of the filtering means 4; thus obtaining an intermediate conformation represented in Figure 2, and Figure 3 schematically in the center thereof; in practice the separation of the first portion 31 is obtained by forming at least one or two weld lines 6 by hot melt of thermoplastic material, and cutting; this same separation can be achieved by techniques other than heat sealing, such sealing or gluing; b) it is only the first part 31 of the casing 3 containing the object 2 but not the filtering means 4, sealed from the external environment, that the outer surface decontamination is subjected to the step 3a of the casing 3, in the decontamination tunnel 11 leading to an enclosure 10 in a controlled atmosphere, in which the object 2 is unpacked.

The conditioning object resulting from steps (a) and (b) is more particularly shown in Figure 4 or in the central portion and bottom of Figure 3.

Claims

1) A process for external decontamination of a packaged object (1), the latter including the object (2) itself, at least the outer surface (2a) is in the decontaminated state, for example sterile, an envelope (3 ) containing said closed object, the interior (5) is in the decontaminated state, for example sterile, and a means of filtration (4) providing a gas passage through the casing, but the threshold cut-off is determined to stop the flow of contaminating agents to the interior of the envelope, said method comprising a step of decontamination of the external surface (3a) of the envelope, characterized in that before the decontamination step the outer surface of the casing: a) forming in the housing (3) at least two portions (31) and (32) respectively determining two compartments (51) and (52) sealed with respect to the the other, a first part (31) containing said object (2), and a second portion (32) comprena nt the whole of the filtration means (4); b) separating the second portion (32) of the first portion (31), maintaining the seal of the first compartment (51); then only submits the first portion (31) at the decontamination step of the outer surface (3a) of the casing (3).
2) Process according to claim 1, wherein the casing (3) consists of a flexible thermoplastic material, characterized in that one obtains the two parts (31) and (32) in the casing (3) hot melt of thermoplastic material, of at least one weld line (6) determining the two said parts (31) and (32) and the two said compartments (51,52). 3) Process according to claim 1, characterized in that the decontamination step of the outer surface (3a) of the casing (3) is performed by illumination of the packaged object with a decontaminating radiation.
4) Process according to claim 1, characterized in that the decontamination step of the outer surface (3a) of the envelope (3) comprises a sterilization step performed by contacting said outer surface (3a) with a sterilizing gaseous medium, especially a sterilizing gas, for example ethylene oxide.
5) Use of a packaged object (1), the latter including the object (2) itself, at least the outer surface (2a) is in the decontaminated state, for example sterile, a shell (3) closed container said object, the interior (5) is in the decontaminated state, for example sterile, and a means of filtration (4) providing the gas passage through the casing, but whose cutoff threshold is determined to stop the flow of contaminating agents to the interior of the envelope, characterized in that: a) through the filter means (4) is discharged from the inside of the envelope (3) the contained gas in the latter, or is filled with a gas, particularly in the decontaminated state, for example sterile, within said envelope (3); b) is then formed in the casing (3) at least two parts (31,32) respectively defining two compartments (51,52) sealed relative to one another, a first part (31) containing said object (2), and a second portion (32) comprising all of the means (4) filter; c) the second portion is separated (32) of the first (31) part, preserving the leaktightness of the first compartment; whereby the first part of the casing (3), evacuated or filled, demonstrates the integrity of the packaging of said object prior to its deconditioning.
6) Use according to claim 1, characterized in that during one step (a), surremplit with said gas within said envelope (3), so as to inflate the latter.
EP19990932926 1998-08-27 1999-07-20 Method for external decontamination of a packaged object Active EP1107913B1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR9810928 1998-08-27
FR9810928A FR2782644B1 (en) 1998-08-27 1998-08-27 Process for the external decontamination of an object packaged
PCT/FR1999/001779 WO2000012388A1 (en) 1998-08-27 1999-07-20 Method for external decontamination of a packaged object

Publications (2)

Publication Number Publication Date
EP1107913A1 true EP1107913A1 (en) 2001-06-20
EP1107913B1 EP1107913B1 (en) 2002-06-05

Family

ID=9530029

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19990932926 Active EP1107913B1 (en) 1998-08-27 1999-07-20 Method for external decontamination of a packaged object

Country Status (8)

Country Link
US (1) US6705061B1 (en)
EP (1) EP1107913B1 (en)
JP (1) JP4426107B2 (en)
AU (1) AU4913999A (en)
DE (1) DE69901715T2 (en)
ES (1) ES2177301T3 (en)
FR (1) FR2782644B1 (en)
WO (1) WO2000012388A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6991096B2 (en) * 2002-09-27 2006-01-31 Medtronic Minimed, Inc. Packaging system
US6996952B2 (en) * 2003-09-30 2006-02-14 Codman & Shurtleff, Inc. Method for improving stability and effectivity of a drug-device combination product
US20080066432A1 (en) * 2004-01-05 2008-03-20 Joon-Young Ahn Container For Vacuum Packing
ITRM20040472A1 (en) * 2004-10-01 2005-01-01 Stelliferi & Itavex S P A A method for packaging products, for example for food products, its packaging and construction kit.
US20080116106A1 (en) * 2006-11-21 2008-05-22 Fred Lampropoulos Packing and sterilizing a pen in a kit
DE102007004114B3 (en) * 2007-01-26 2008-02-14 Sartorius Biotech Gmbh Protected filter units e.g. for safety filtration, include two non-gas-permeable packaging materials
JP2011030727A (en) * 2009-07-31 2011-02-17 Manii Kk Packaging bag for medical supplies, packaging bag containing medical supplies, and method for packaging medical supplies

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Publication number Priority date Publication date Assignee Title
NL7703779A (en) * 1976-04-13 1977-10-17 Cordis Dow Corp Method for the production of a gas-impermeable packaging, and package obtained according to this method.
US4467588A (en) * 1982-04-06 1984-08-28 Baxter Travenol Laboratories, Inc. Separated packaging and sterile processing for liquid-powder mixing
JPH0470023B2 (en) * 1985-09-27 1992-11-09 Nisso Kk
US4998400A (en) * 1986-03-22 1991-03-12 Material Engineering Technology Laboratory, Incorporated Medical fluid-filled plastic container and methods of making same
US5033252A (en) * 1987-12-23 1991-07-23 Entravision, Inc. Method of packaging and sterilizing a pharmaceutical product
FI94043C (en) * 1992-12-23 1995-07-10 Kolmi Set Oy Method and deodorized to yield a sterile package and obtained by the method of packaging the product to be sterilized
US5997811A (en) * 1997-07-02 1999-12-07 Cohesion Technologies, Inc. Method for sterile syringe packaging and handling

Non-Patent Citations (1)

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Title
See references of WO0012388A1 *

Also Published As

Publication number Publication date
US6705061B1 (en) 2004-03-16
WO2000012388A1 (en) 2000-03-09
DE69901715T2 (en) 2002-09-26
DE69901715D1 (en) 2002-07-11
JP4426107B2 (en) 2010-03-03
FR2782644B1 (en) 2001-08-31
FR2782644A1 (en) 2000-03-03
ES2177301T3 (en) 2002-12-01
JP2002523313A (en) 2002-07-30
AU4913999A (en) 2000-03-21
EP1107913B1 (en) 2002-06-05

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