DE7148814U - Device for sterilizing packaging materials - Google Patents

Description

¹ Karlsruhe, 17.'2. 1977 ZJP / Ho / Rth

INDUSTRIE-WERKE KARLSRUHE AUGSBURG Aktiengesellschaft Gartenstrasse 71

7500 Karlsruhe 1

Device for sterilizing packaging materials

The invention relates to a device for sterilizing packaging means, such as the reception of medicaments Serving ampoules made of one (or more) or made of thermoplastic material, aluminum or the like. Existing Formed film web and filled with the also aseptic drug and sealed, wherein the device is made aseptic before it is put into operation and aseptic by adding it during operation Air is kept sterile in excess pressure.

7148B14? RnR.77

It has long been known in pharmaceutical practice to use smaller quantities, in particular, of liquid medicaments Foils made of thermoplastic material, aluminum or the like on packaging machines for so-called single-dose packs to pack.

After the pack has been produced, heat sterilization should be avoided as much as possible, as this is desirable in every case as few killed bacteria as possible in the packaged To have pharmacon. There is therefore a need for packaging film, packaging machine and Filling equipment to create sterile conditions that allow real aseptic packaging.

In order to achieve the above objective, it is necessary to the following requirements must be observed:

1.0 The packaging machine must be disinfected or sterilized;

2.0 The sterile state must be maintained during operation permit;

3.0 It must be possible to disinfect or sterilize the packaging material in the company; ·

4.0 The unit used to dispense the drug must be easy and simple to disinfect or. let it sterilize, and finally

5.0 the pharmaceutical must be able to be disinfected or sterilized before being fed into the dosing unit.

For the disinfection or sterilization of devices for For the automatic and aseptic packaging of pharmaceuticals, one of the following methods usually comes into consideration :

a) heat sterilization under pressure;

b) sterilization with ethylene oxide;

c) disinfection with chemicals in liquid or vapor form, and

d) Sterile filtration of liquids.

The method for a) is a relatively safe and quick process, since the sterilization at temperatures around 125 ° C is to be effected in about 20 to 30 minutes.

The method for b) takes place at about 55 ° C and at one Pressure of ρ = 5 to 6 kp / cm. The sterilization time is around 80 minutes. This method is generally

think it is unsuitable for fast-running processes because it is not very efficient. In addition, the Handling ethylene oxide is not without risk, as ethylene oxide forms explosive mixtures with air in a known manner. In order to counter this deficiency, in pharmaceutical practice is often with mixtures of AO and COp worked.

The method for c), which depends on the case at hand can be used with or without thermal influence, usually only kills certain categories of bacteria with certainty from; however, the degree of sterilization that can be achieved with this method is generally sufficient Requirements of pharmaceutical practice, especially since it is easy and relatively inexpensive to handle.

Finally, the method for d) is based on knowledge gained ideal for the sterilization of liquids to be filled, as the filtered liquids not only sterile, but also free from dead bacteria.

In the German patent specification No. 1 025 324 a device for producing filled containers, such as ampoules made of thermoplastic material are proposed. This device comprises a packaging housing, which before the device is put into operation

-D-

7148814 7R0R77

is sterilized by briefly exposing it to UV radiation. The one achieved by the UV exposure The sterile state is also maintained during operation by supplying sterile air into the housing. This arrangement ensures that an increased pressure of sterile air is created, which makes penetration more harmful Prevents air or gas from entering the housing. As a result, the inside of the housing is kept sterile at all times.

During operation, the packaging material is then also sterilized using the proposed device; ~ For this purpose, two strips of material are introduced from supply rolls into a housing belonging to the device, which contains the unspecified means for sterilizing the strips of material. When leaving the housing the material strips are then introduced into the packaging housing via deflection rollers, in which now the Ampoules are produced which, like their contents, are completely sterile when they leave the device.

Furthermore, in the Dutch patent application 69 13 256 a device for producing filled containers suggested. This device also comprises a packaging housing, which before putting the Device is sterilized in an unspecified manner, and which during operation of the device

714R8U? R ΠΒ77

is kept sterile by supplying sterile air under positive pressure into the interior of the housing.

While the proposed device is in operation, a web of packaging material is continuously sterilized. the Packing web is introduced into a disinfection bath via deflection rollers. It then runs over a pair of squeezing rollers into a second sterilization zone, from where it gets into the packaging housing. There it becomes sterile Filling goods are filled into the packaging material web that has been formed into a tube and the tube is assembled into individual containers .

Finally wui'fe in the German Auslegesohrift 1 815 538 a device for the aseptic packaging of goods, in particular foodstuffs, in a container using of an aseptic agent. Here, a container provided with a bottom is placed under a Led nebulization nozzle; the aseptic agent is in the atomized state with the inner surfaces of the container in Brought contact and then removed again from the container, whereupon it is then filled with a product and means a lid is closed.

As experience has shown, when packaging high-quality pharmaceuticals, higher demands are placed on sterility as this is the teaching in particular

- 7 -

714RRU 75 08 77

-V-

. mediated according to the German publications 1 025 324 and 1 βΐ5, where this is done either under the action of ultraviolet rays or by spraying aseptic agents.

The present invention has therefore set itself the task of ^ he already proposed or known devices such to improve that without difficulty ( "speeds and high-quality pharmaceuticals can be made completely germ-free. For as readily should be apparent need for such packaged goods For this reason alone, considerably greater demands are made than these are "injected intravenously or intramuscularly in not a few cases" in both human and veterinary medicine and, in the event of insufficient sterilization of both the packaging material and the packaged goods, septicemia, in particular due to pyogenic pathogens , were in the wake.

The object is achieved according to the will of the invention essentially in that a chamber which is filled with disinfectant and which is closed on all sides a second chamber separated from this is arranged downstream, to which a channel is connected, with the between the first chamber and the channel arranged second chamber is provided with an extendable and retractable insert which

714BR14? R or 77

at the same time several deflecting the ones passed through the chamber Rolls, rolls or the like that serve the film web Corresponding rollers are formed into pairs of squeezing rollers.

According to another feature of the invention, the amount of second chamber several times its width.

Another essential feature of the invention is that the retractable and extendable insert with Walls provided and is designed such that together with a wall fixedly arranged in the chamber several cells connected in series, between which relatively small gaps are provided for the passage of the disinfectant.

If heating the disinfectant is necessary or desirable, it can be done at will the invention of the second chamber od a heat exchanger. The like. Associate which is connected to a supply line, wherein this after closing a valve for regenerating the disinfectant that can be fed into the chamber if necessary - is provided.

According to another feature of the invention, lines and valves are used for. Removal of the disinfectant '. after loading

end of the disinfection time planned.

The proposed invention is supplemented and perfected Finally, in that the channel is assigned an air channel for blowing in sterile air.

It is obvious that the proposed invention is a Brings a number of advantages, which should be mentioned below:

The device according to the invention ensures greater security than the known devices already mentioned an absolutely perfect disinfection of both the packaging film and the packaging machine itself, which essentially takes place through the flooding of the central chamber and the channel spatially downstream of this, the Temporarily remain flooded until all the bacteria there are definitely killed. Of the A germ-free state is achieved by inflating the same air under overpressure, even with or after the liquid level has been lowered maintained at zero.

Another advantage of the device according to the invention is the easy retraction and extension of the insert to be highlighted in or out of the central chamber, through which in turn the entry and exit of the withdrawn from the roll Foil web is facilitated in a not inconsiderable way.

- 10 -

714B814 7Rf) R 77

Finally, it is also advantageous to divide the central chamber into several cells, essentially for their formation only one (central) wall fixed to the chamber is required, while the cells lying next to it are at the same time are formed by the walls of the retractable and extendable insert, which also have the lower deflection rollers wear. This relatively simple training method significantly reduces the risk that possibly Bacteria adhering to the film web due to the transport movement of the film web from one cell to the other and from the last of them get into the sewer.

In the drawing, the invention is shown in an exemplary embodiment without, however, being in this alone to exhaust. It shows:

Fig. 1 d.i..e device in side view, Fig. 2 the device according to Fig. 1 in elevation,

3 shows a partial section of the device according to FIG Fig. 1, and finally

Fig. 4 is an enlarged view of the central chamber in vertical section.

7148814? RiiR77

. --H - ■ ■ // Cf

In FIGS. 1 and 2, a film web 2 is introduced from a supply roll 1 via deflection rollers 3, 4 into the chamber 5 filled with a detergent. Via a deflecting roller 6 arranged in the chamber 5, the film web then passes over a pair of nip rollers 7, including a second chamber filled with distilled water. A roller 9 deflects the film web 2 in the chamber 8; it finally arrives via a further pair of squeezing rollers 10, 10a and a deflection roller 13 in a channel 11, where it is held in place by means (not shown) and also not belonging to the invention until the entire device has been disinfected. For this purpose, the (central) chamber and also the channel 11 connected downstream of it are flooded with a disinfectant until the cover 12 is also sprayed over by the disinfectant. In this state, the device remains stationary for a certain time, during which the disinfectant can be supplied with heat as required via a heat exchanger 13c (FIG. 4) and its supply line 13a. After the disinfection time has elapsed, the disinfectant is drained through lines and valves 14, 14a, 15, 15a. To the extent that the mirror of the

Disinfectant in the (central) chamber 8 as well as in the channel lowers, sterile air is blown into the channel 11 via an air channel 16, which is via bores, not shown arrives in a cathedral 17, from where she finally

- 12 -

7148814 7RfIR 77

is discharged into the open. In this way it is achieved that a lightweight, only a few millimeters WS A significant overpressure in sterile air arises, which prevents germs from penetrating the device with certainty prevented; the overpressure in sterile air is maintained even during operation of the device.

The disinfection or sterilization process can of course also be carried out by evaporating a disinfectant, such as formalin or the like.

The (central; chamber 8 shown in FIG. 4 consists essentially of a vessel 8a, which is known per se Way for thermal insulation with an insulation layer, not shown, can be provided. In the middle of the jar 8a a partition 8b is attached, which initially divides this into two cells of approximately the same size. Through walls 18a, 18b of an insert 18, which you do not belong to the invention in the direction of the double arrow Means can be moved in and out of the vessel 8a, the vessel is divided into further cells. In retracted Position leave the walls 18a, 18b from the bottom 8c only small gaps open, so that there is a risk of penetration For example, germs adhering to the film web 2 are reduced from one cell to the other to a minimum will. The walls 18a, 18b as well as the insert also serve to accommodate and support pulleys

- 13 -

7148814 08/25/77

19, 19a, 19b. Via line 14 and valve I4a can the vessel must be emptied. After closing valve I4a can the disinfectant, if necessary regenerate in the vessel 8a.

Considered publications:

DAS 1 025 324 DOS 1 815 538 NL-OS 6 913 256

7148814 08/25/77

Claims (6)

PROTECTION CLAIMS 1. Device for sterilizing packaging materials, such as the reception of drugs serving ampoules consisting of one (or more) ζ made of thermoplastic material, aluminum or the like. formed existing film webs and filled with the also aseptic drug and sealed be, the device before its incl. Drift set made germ-free and during operation is kept aseptic by supplying aseptic air in excess pressure, characterized, one
that one filled with disinfectant, f chamber (5) closed on all sides, one of these downstream of the sealed-off second chamber (8), to which a channel (11) is connected, the between the first chamber (5) and the channel (11) arranged second chamber (8) with an out and retractable insert (18) is provided, which at the same time several deflecting the through the chamber (8) Film web (2) serving rollers, rollers or the like (19, 19a, 19b) carries, while others 7148814 2R.nR.77 Roll. (7, 10a) with corresponding rollers (7a, 10) arranged outside to form pairs of squeezing rollers (7, 7a, 10, 10a) are formed. 2. Device according to claim 1,
characterized, that the height of the second chamber (8) is a multiple of its width. 3- device according to claims 1 and 2, characterized in that that the retractable and extendable insert (18) is provided with walls (18a, 18b) and designed in such a way is that it, together with a wall (8b) which is fixedly arranged in the chamber (8), connects several one behind the other Cells results between which relative to the passage of the disinfectant small gaps are provided. 4. Device according to claims 1 to 3, characterized in that that the second chamber (8) is assigned a heat exchanger or the like (13c) which is connected to a supply line (I3t>) 7148814 7R.nfi.77 is connected, this after closing a valve (i4a) for regeneration if necessary of the disinfectant that can be fed into the chamber is provided. 5. Device according to .den claims 3 and 4, characterized in that that lines (14, 15) and valves (i4a, 15a) to Expiry of the disinfectant after the end of the disinfection time are foreseen. 6. Device according to claim, characterized in that that the channel (11) is assigned an air channel (16) for blowing in sterile air. 7148814 7R na77