WO2013104449A2

WO2013104449A2 - Closable unit for an insolator or clean room

Info

Publication number: WO2013104449A2
Application number: PCT/EP2012/072238
Authority: WO
Inventors: Albrecht Kuehnle; Benjamin Hoffmann; Manuel Schacht
Original assignee: Robert Bosch Gmbh
Priority date: 2012-01-11
Filing date: 2012-11-09
Publication date: 2013-07-18
Also published as: CN104040264A; WO2013104449A3; DE102012209961A1; WO2013104449A9; EP2802823A2

Abstract

The present invention relates to a unit for introduction into an isolator (2) or clean room, comprising a housing and a reclosable cover (14) which is securely connected to the housing, the cover (14) being designed to hermetically seal at least one side (9) of the unit (12).

Description

description

title

Lockable unit for an isolator or clean room prior art

The present invention relates to a unit for insertion into an isolator or clean room. In particular, the present invention relates to a filter unit for insertion into a return air or exhaust duct of an insulator or

Clean room, an isolator or clean room with the appropriate filter unit and a method for operating an isolator or clean room.

In particular, in the packaging and filling of liquid medicines both isolators and clean rooms are used for product protection and personal protection. The number of highly active substances and those used as cystatics in cancer therapy is steadily increasing in the pharmaceutical industry. To protect the product and the operators, suitable filter stages and filter arrangements are required. Here, bag-in / bag-out filter systems are preferably used which, in addition to the actual air filtration, also permit a contamination-free filter change. In addition to the filter, the air ducts to the filter are usually contaminated. Therefore, there is a need to clean these air ducts. This is called the wash-in-place process. This wash-in-place process is usually carried out with permanently installed spray heads in the air duct. The washing medium used is extensively treated water. In which

Changing the filters are usually separate covers in the

Clean room or introduced into the isolator. With these covers the used filter can be closed and disposed of. a

exemplary insulator shows the document DE 199 47 781 C1. In addition to filters also various other items must be inserted and removed and cross-sections must be closed without contaminating products, the environment or humans.

Disclosure of the invention

The unit according to the invention with the features of claim 1 has an integrated cover for closing contaminated sides or surfaces of the unit. This provides a simple and secure way to insert and remove the units or can without additional

be introduced material a cross-section. There is no need for cumbersome packaging of the units in separate containers or foils, and no closure elements, e.g. Lid, for closing cross sections introduced or stored inside the insulator. These advantages are achieved by a unit for insertion or insertion in an insulator or clean room, comprising a housing and a fixed to the

Housing connected, resealable cover, wherein the cover for hermetically sealing at least one side of the unit is formed. The housing is in its simplest form merely as a frame

educated. When the unit for closing a cross section (e.g., a floor drain or a waste port) is formed in the insulator or clean room, the unit includes a frame fixedly installed around the section to be closed. The cover is integrated on the frame. If the invention is used for a unit to be inserted and removed (eg a filter unit), the cover will also be integrated directly into the unit.

The dependent claims show preferred developments of the invention.

The advantageous embodiment of the unit as a filter unit with the features of claim 2 makes it possible to keep the potentially contaminated surfaces as low as possible. Furthermore, a low-contamination filter change is possible and during the cleaning of the air ducts, in particular with liquid media, the filter is protected from splash water. Both the protection of the filter from splash water and the closing of the filter takes place in the closed system of the isolator or clean room. Furthermore, the required

filter unit according to the invention in the clean room or insulator relatively little space. The

Cover for closing the filter is integrated in the filter unit and does not have to be stored separately in the clean room or insulator. The cleaning and replacement of the filter is very efficient, so that both the investment costs and the running costs for the operator of the

Clean room or insulator very low. The used filter unit can be closed and decontaminated in the isolator or clean room. This allows a saving in the fluid cleaning agent, its treatment and disposal. It is particularly advantageous that no additional material has to be introduced into the isolator or clean room in order to close or to clean the filter. This allows the filter in the closed system

be closed and without the risk of contamination of the

Operators or the outside space are replaced. All these advantages are achieved by the advantageous filter unit for insertion into a return air or exhaust duct of an insulator or clean room, comprising a filter housing, a filter inserted into the filter housing, and the resealable connected to the filter housing and / or filter

Cover. The cover is designed for hermetically closing the air inlet side of the filter. According to the invention, this cover is integral and integral part of the unit. The cover is used as an integral part of the filter unit together with the filter housing and the filter in the return air or exhaust duct. After use, we use the whole

Filter unit removed again.

The term "isolator" or "clean room" is also a so-called

These barrier systems are also known as "barrier systems"

Restricted Access Barrier System (RABS). The return air ducts can lead both the air directly from the processing space of the insulator or from the inlet and outlet locks to the air inlet side of the filter. Furthermore, the return air or exhaust air ducts do not have to be configured as tubular ducts. For example, a gap between a double-walled glass pane can serve as a return air or exhaust duct.

In particular, it is provided that the cover is formed as a plastic film. The plastic film is resistant to the cleaning and decontamination media used. Furthermore, the plastic film is at least as thick designed so that it does not tear when repeated closing and opening or when touching with edged objects.

Furthermore, it is preferably provided that the cover can be rolled up and down or attached to and folded on the unit. In particular, it is provided for this purpose that at least one edge of the cover is fixedly connected to the unit, preferably the filter housing or the filter. In particular, this one edge is clamped and / or glued between the filter housing or the filter. At the remaining edges, a resealable closure device is particularly preferably arranged. These

Closure device is preferred as a sliding closure and / or

Zipper and / or Velcro and / or zip closure formed. The edge or the plurality of edges, on which the closure device is arranged, can be formed with rounded corners, so that, for example, a continuous sliding closure can be used to close the entire cover. A zip-lock is a re-sealable tongue-and-groove joint, known for example from

Freezer bags. Alternatively or in addition to the closure device mentioned above, a magnetic closure is provided between the cover and the unit. At least one of the cover and the unit must

be provided magnetic element or a magnetic surface. It is sufficient if one of the magnetic elements or one of the magnetic surfaces is permanently magnetic and the opposite side is ferromagnetic.

Both the mechanical closure devices and the magnetic closure requires no auxiliary power for opening and

Close the cover. In particular, the cover remains closed without auxiliary power.

Particularly preferably, the cover is formed as a magnetic film. Under the hermetic sealing of the air inlet side with the cover is in particular a gas and / or fluid-tight closing of the filter to understand.

The invention further comprises an isolator or clean room, in particular for filling or packaging medical products, with a return air or exhaust duct and at least one filter unit according to one of the preceding claims, wherein the filter unit is inserted into the return air or exhaust duct so that the air inlet side the filter is loaded with contaminated air from the insulator or clean room. The advantageous embodiments described in the context of the unit according to the invention find correspondingly advantageous application to the isolator or clean room according to the invention.

The invention further comprises a method for operating an isolator or clean room, comprising the following steps in the following order: (i) providing an isolator or clean room with at least one filter unit as just described in the return air or exhaust duct of the isolator or clean room , wherein the cover of the filter unit is open. (ii) using the isolator or clean room. In particular, in the isolator or clean room, a filling or packaging of medical products, (iii) closing the cover and cleaning the insulator or clean room, in particular with a liquid medium.

After cleaning with the liquid medium, the cover is preferably opened again and bio-decontamination takes place, in particular with hydrogen peroxide vapor.

The advantageous embodiments described in connection with the unit according to the invention or in conjunction with the isolator or clean room according to the invention find correspondingly advantageous application to the method according to the invention.

By closing the filter by means of the cover, the filter is effectively protected during machine cleaning against the cleaning medium. During the subsequent decontamination cycle, the cover is reopened. Since it is decontaminated with a vapor or gaseous medium comes In this case, the entire surface of the cover in contact with the

Decontamination agent and is thus effectively sterilized. According to the invention, it is not necessary to introduce cover components for the filter unit into the isolator or clean room, since the cover is more integral and stronger

Part of the filter unit is.

Before removing the filter unit, the potentially contaminated filter surface is completely covered by closing the cover. This is done in the closed state of the insulator or clean room. Subsequently, the interior of the insulator or clean room and the outside of the cover of the filter unit is cleaned and dried. Thereafter, a corresponding attachment of the filter unit is released to remove the filter. Now that can

Filter unit can be removed. For disposal, the removed

Filter unit packed in a container and then brought to the destination. Preferably, the removed filter unit can also be stored and used for the processing of the same or similar active ingredient back into the insulator or clean room.

In particular, the area of the filter is chosen such that the

Flow velocity reaches a maximum of 2 m per second. The attachment of the filter unit in the insulator or clean room is preferably dense. Furthermore, the filter unit is preferably arranged in insulators in such a way that the operator performs the necessary work, such as opening and closing

Closing the cover, which can be used by gloves.

Short description of the drawing

Hereinafter, three embodiments of the invention will be described in detail with reference to the accompanying drawings. Showing:

1 shows an insulator according to the invention with a

unit according to the invention, designed as a filter unit, according to all embodiments,

2 shows an inventive unit, designed as a filter unit, according to a first embodiment, 3 shows a unit according to the invention, designed as a filter unit, according to a second embodiment, and

2 shows a unit according to the invention, designed as a filter unit, according to a third embodiment.

Embodiments of the invention

With reference to Figure 1, an inventive insulator 2 with the

units according to the invention, designed as filter units 1, presented. The filter unit 1 exemplifies various units, e.g. Auxiliaries, which are in and out of the insulator 2 or for integrated frame defining a cross-section to be closed in the insulator 2.

The insulator 2 has a hermetically sealed processing space 4. In this processing space 4 is a filling machine 5 for liquid or powdered medicines. The drugs are in

Drug container 6 bottled. Access by the user is via the rubber gloves 7. Not shown are on and

Exit locks, for example for the drug container 6. Between a glass double disc, a return air duct 3 is formed. This

Return air duct 3 leads from the filter units 1 into the pressure plenum 10a. With the arrows shown in bold, an air flow 8 in the insulator 2 is shown. The

Air flow 8 leads from an air outlet side 10 of the filter units 1 via return air ducts 3 to an air inlet side 9 of the filter units 1.

Figure 2 shows in detail the filter unit 1 according to a first

Embodiment. The filter unit 1 comprises a filter housing 1 1. Part of the filter housing 1 1 is a frame 13. In the filter housing 1 1, a filter 12 is inserted. FIG. 2 shows the air inlet side 9 of the filter 12.

Furthermore, the filter unit 1 comprises a cover 14. The cover 14 is formed as a plastic film. The frame 13 on the air inlet side 9 of the filter unit 1 is rectangular. In a corresponding manner, the cover 14 is rectangular. An upper edge 16 of the cover 14 is fixed to the Filter unit 1 connected. At the remaining edges of the cover 14 and on the corresponding mating surfaces of the filter 12 and the filter housing 11, a closure device 15 is formed. This closure device 15 is resealable, for example, as a sliding closure formed. In the open state, the cover 14 can be rolled up or turned up. When closed, the cover closes

14, the air inlet side 9 of the filter 12 hermetically. In particular, a gas and / or fluid-tight closure is provided. Figure 3 shows a second embodiment of the filter unit 1. The same or functionally identical components are provided in all embodiments with the same reference numerals. Also in the second embodiment, the filter unit 1 comprises a filter housing 11 with a frame 13. In the filter housing 1 1, the filter 12 is inserted. Shown in FIG. 3 is the plan view of the air inlet side 9.

In contrast to the first embodiment is in the second

Embodiment, the edge of the cover 14 with the closure device

15 formed with rounded corners. Furthermore, here the frame 13 is extended by a frame-fixed foil portion 17. This film portion 17 is fixedly connected to the filter housing 11 and / or the filter 12. The

Closing device 14 connects in fluid and / or gas-tight manner, the cover 9 with this frame-fixed film part 17. According to the invention, the filter unit 1 used can be closed and opened in a simple manner within the insulator 2. Especially during cleaning with fluid cleaning agents, this rapid closure of the filter 12 proves to be very beneficial. Furthermore, before changing the filter unit 1 very quickly and user-friendly

Cover 14 are closed, and thus the filter unit 1 without a

Danger of contamination of operating personnel or environment to be replaced.

Figure 4 shows a third embodiment of the filter unit 1. The same or functionally identical components are provided in all embodiments with the same reference numerals. Shown in Figure 4 on the left side of the complete filter unit 1. On the right side a detail of the section AA is shown.

Also in the third embodiment, the filter unit 1 comprises a filter housing

1 1 with a frame 13. In the filter housing 11, the filter 12 is inserted. The frame 13 is supported via an optional frame bracket 18.

In the third embodiment, the cover 14 is formed as a magnetic sheet. The filter 12 is at least partially magnetic, so that the cover 14 in the closed state by the magnetic force on the filter

12 sticks.

Alternatively, the cover 14 can overlap with the frame 13 and the frame 13 represent the magnetic counter surface for the magnetic film. Furthermore, the cover 14 is preferably provided on a support

aufzuspannen to allow a flat lifting and closing.

It can be used a further cover 14 on the opposite side of the filter 12, not shown, so that the opening of the cross sections can be done automatically, for example, by a pending differential pressure.

Claims

claims

Unit (1) for insertion or insertion into an isolator (2) or clean room, comprising:

a housing, and

a resealable cover (14) integral with the housing, the cover (14) being adapted to hermetically seal at least one side (9) of the unit (12).

Unit according to claim 1, characterized in that the unit is a filter unit (1) for insertion into a return air or exhaust duct (3) of the insulator (2) or clean room, wherein the filter unit (1)

a filter housing (1 1), and

a filter (12) inserted into the filter housing (11), the resealable cover (14) being fixedly connected to the filter housing (11) and / or filter (12), and the cover (14) for hermetic sealing the air inlet side (9) of the filter (12) is formed.

Unit according to one of the preceding claims, characterized

characterized in that the cover (14) is formed as a plastic film.

Unit according to one of the preceding claims, characterized

in that the cover (14) can be wound up and down or attached and closed on the housing, preferably on the filter housing (11) or on the filter (12).

5. Unit according to one of the preceding claims, characterized

in that at least one edge (16) of the cover (14) is fixed with the housing, preferably with the filter housing (1 1) or the filter (12) is connected.

6. Unit according to claim 5, characterized in that to the

remaining edges a resealable closure device (15) is arranged.

7. Unit according to claim 6, characterized in that the

Closure device (15) comprises a sliding closure and / or a zipper and / or a hook and loop fastener and / or a zip closure.

A unit according to any one of claims 1 to 5, characterized by a magnetic shutter, the magnetic shutter attracting between the cover (14) and the housing,

preferably the filter housing (11) and / or the filter (12), effected in the closed state.

9. Unit according to claim 8, characterized in that the cover (14) is wholly or partially magnetic.

10. Unit according to claim 8 or 9, characterized in that the

Cover (14) is formed as a magnetic film.

1 1. Isolator (2) or clean room comprising at least one unit according to one of the preceding claims.

12. Isolator (2) or clean room, in particular for filling or packaging medical products, with a return air or exhaust air duct (3) and at least one filter unit (1) formed unit according to one of claims 2 to 10, wherein the filter unit (1). before or in the return air or exhaust air duct (3) is inserted so that the air inlet side (9) of the filter (12) with contaminated air from the insulator (2) or clean room can be acted upon.

13. A method of operating an isolator (2) or clean room, comprising the following steps in a given order:

Providing an insulator (2) or clean room with at least one unit designed as a filter unit (1) according to one of claims 2 to 10 in the return air or exhaust air duct (3) with the cover (14) open,

Using the isolator (2) or clean room, in particular for filling or packaging medical products, and

Closing the cover (14) and cleaning the insulator (2) or clean room, especially with a liquid medium.

14. The method according to claim 13, characterized in that after cleaning the cover (14) is opened again and a

Decontamination of the insulator (2) or clean room, especially with a gaseous or vaporous medium occurs.