DE3841930A1 - Device and method for cleaning, sterilising and drying small objects, especially pharmaceutical seals - Google Patents

Abstract

In the case of a device and/or a method for cleaning, sterilising and drying small objects, especially pharmaceutical seals, the objects (74) are flushed into an inner drum (4) which is rotatably mounted in an outer drum (2), the outer drum (2) being heatable by means of a heating jacket (24). At least the inner drum (4) is inclined at an angle of 3 to 5@ with respect to the horizontal. Inside the outer drum (2) there are provided two spraying pipes, one (18) of which is stationary and sprays the objects (74) in the inner drum (4), while the other spraying pipe (12) rotates in synchronism with the inner drum (4). The circulating spraying pipe (12) causes steam to be generated on the heated-up walls of the outer drum (2), which steam creates a high pressure saturated steam atmosphere of 121@C inside the outer drum (2). Mixing of the objects (74) in the inner drum (4) is carried out by means of a conveying worm (14), by means of which cleaned and then dried objects (74) can also be automatically conveyed out of the inner drum (4). <IMAGE>

Description

The invention relates to a device according to the Ober Concept of claim 1 and a method according to Preamble of claim 11 for cleaning, sterilization Ren and drying small objects, especially phar pharmaceutical closures.

Pharmaceutical closure elements, which primary ele represent pharmaceutical packaging and thus in direct contact with a drug, require careful finishing, at highest demands are made. With continuous Lich working cleaning machines exist as well for batch cleaning machines The main problem is pollution of the ver avoid conclusions by particles that are already from other closures have been cleaned.  

Attempts have already been made to address this problem through a Separation of the closures during washing and cleaning to meet. For this, the closures to be cleaned se on a carrier drum at a mutual distance sets and there during the cleaning process Negative pressure held. These known methods that work with a separation of the closures has not proven itself in practice, however, since common post-treatment required, such as sterilization ren, drying and siliconizing with the in the be individual closures can be performed. In addition, these processes or devices necessary for this are very complex and despite the uneconomical.

In the generic DE-OS 32 48 555.7 is therefore a Device for cleaning, sterilizing and drying small items, especially pharmaceutical ones Closure elements proposed, which are batchwise is working. To this end, it is proposed a rotating Inner drum in a lockable outer drum arrange, with the outer drum at its lower order catchment area has a heating jacket. Coaxial to In inner and outer drum and together with the inner drum A spray tube is rotatably arranged, which on its Circumference a plurality of radially outwardly facing Has spray nozzles. Furthermore is in the inner drum projecting radially inward a plurality of stirrers elements provided in the form of wing-like plates, which when the inner drum rotates relative to Outside drum the small objects steadily on the one hand mix and keep moving and on the other hand here the small objects in the water curtains of the spray nozzles so that these objects through the water curtain or the water curtains fall through and be cleaned. Between  the outer peripheral surface of the inner drum and the inner peripheral surface of the outer drum is a second spray rotating around the inner drum arm provided by means of the cleaned particles of the inner peripheral surface of the outer drum can be.

Although the device according to DE-OS 32 48 555.7 cleans the pharmaceutical closures satisfactorily, there are some significant disadvantages in practical operation:
For example, loading and unloading the inner drum is relatively cumbersome. In particular, the emptying of the inner drum after the cleaning process has been completed by a flap arranged on the circumferential wall of the outer drum is cumbersome and time-consuming, and there is also the risk of the necessary manipulations that the already sterilized closures are contaminated again.

For proper sterilization of the closures is required that inside the cleaning or Ste Rilisationsvorrichtung a temperature of 121 ° C. must. In the device according to DE-OS 32 48 555.7 this high temperature is achieved in that the outer drum is heated in its base area, with additional sterile superheated steam inside drum is blown. That blown sterile Superheated steam must be the one initially in the drum and relatively cold atmospheres compared to superheated steam displace air, so that the heating of the device takes a relatively long time. Furthermore, in some cases the provision of sterile superheated steam itself To make trouble.

Because the spray tube, which is coaxial to the inner and outer flow  mel is arranged in the inner drum, in synchronism with the If the inner drum turns, it becomes washing or rinsing liquid also sprayed into the areas of the inner drum where there are no closures to be cleaned at all, so that part of the rinsing or cleaning liquid is unused uses remains.

In contrast, it is an object of the present invention a device according to the preamble of claim 1 and a method according to the preamble of the claim 11 to create, in which the above still ver Permanent disadvantages of the prior art according to the DE-OS 32 48 555.7 are switched off or avoided, i.e., a device for cleaning small objects and to create a process for this, which a practically fully automatic batch cleaning small ner items, especially pharmaceutical ver closing elements with high efficiency and economy allowed.

This object is achieved according to the invention by the features listed in claim 1 or 11.

Advantageous further developments of the invention result from the respective subclaims.

Further details, features and advantages of this ing invention emerge from the following Be description with reference to the drawing.

It shows:

Fig. 1 shows, partly schematically simplified OF INVENTION a dung device according to during the process step "cleaning",

FIG. 2 is a view according to FIG. 1 of a device according to the invention during the process step "emptying";

Fig. 3 schematically simplified a front view of the device according to the invention and

Fig. 4 schematically simplified a plan view from above of part of the device according to the invention.

The embodiment of the device according to the invention shown in FIGS . 1 to 4 is particularly suitable for cleaning, siliconizing, sterilizing and drying pharmaceutical closure elements, such as rubber stoppers for injection and infusion bottles; however, it is not limited to this, but can be used wherever sensitive small parts are to be largely freed of adhering particles.

Comprises according to FIGS. 1 and 2 according to the invention before direction substantially a pressure-resistant and pressure-tight shaped outer drum 2, and a coaxial herein arranged inner drum 4, which has a plurality of perforation holes in the manner of a washing machine drum at its circumference, or which in the manner of a grid cage is built with a narrow mesh spacing. The inner drum 4 is mounted on a shaft 6 which penetrates the outer drum 2 in a Druckdich th implementation. The inner drum 4 is rotatable relative to the outer drum 2 , which is achieved by means of a suitable drive, for example an electric motor 8 , which is coupled to the shaft 6 via a toothed or V-belt 10 . At least the inner drum ( 4 ), but preferably the inner and outer drums are not exactly horizontally aligned, but are inclined to the horizontal by an angle of approximately 3 to 5 °. The shaft 6 is formed as a hollow shaft and is in the interior of the outer drum 2 with a spray tube 12 in connection, which has a plurality of radially outwardly pointing spray nozzles. Since the spray tube 12 is connected to the shaft 6 , which in turn drives the inner drum 4 , the spray tube 12 rotates synchronously with the inner drum 4 .

On the inner peripheral wall of the inner drum 4 , a stirring element 14 is arranged, which according to the invention is in the form of a multi-start screw. Am in Fig. 1 and 2, the right end of the screw 14, a routing is constructed plate 16, whose function will be explained below.

As can be seen in particular from FIGS. 3 and 4, another spray tube 18 opens into the interior of the inner drum 4 with a plurality of spray nozzles which, according to FIG. 3, are arranged on the spray tube 18 in such a way that they point essentially obliquely downwards. The spray cone emanating from the individual spray nozzles of the spray tube 18 can be seen in FIG. 3 with the reference symbol 20 . As can further be seen in particular from FIGS. 3 and 4, opens into the interior of the inner drum 4, a Einspülrohr 22 whose function will also be discussed in more fol lowing.

The outer drum 2 is completely surrounded on its outer circumference essentially by a heating jacket 24 which can be heated with superheated steam. Furthermore, the outer drum 2 is connected to a plurality of lines for leading and draining various fluids, which are known in principle and are therefore only briefly explained. Referring to FIGS. 1 and 2, an air supply 26 with a pre-filter 28, a fan 30, an Ste rilfilter 32 and a heater 34 is provided. Also provided is a pump 36 which conveys a cleaning fluid, ie water, into the inner drum 4 via a filter 38 . Via a line 40 , which is connected to the lowest point of the outer drum 2 , namely to an unloading cone 42 , the pump 36 generates a closed fluid circuit.

Also provided are a water inlet 44 , a water outlet 46 for emptying the outer drum 2 , an exhaust air opening 48 , safety lines 50 and 52 for releasing excess pressure, an exhaust air duct 54 which opens into a cooler and collecting container 56 , a cold water line 58 also going into the Radiator 56 opens. A jacket cooling line 60 branches off from the cooler 56 to the heating jacket 24 . Hot steam is fed to the heating jacket 24 via a further line 62 to heat it up.

Referring to FIGS. 3 and 4, the air supply 26 opens into a 3-way valve 64, which further communicates with the Einspülrohr 22 and a hopper 66 in conjunction. The feed hopper 66 is in turn connected to a water inlet 68 .

At the lowest point of the outer drum 2 , the loading cone 42 is provided, which can be closed in a pressure-tight manner by means of a suitable cover 70 .

The filter 38 can be backwashed via a line 72 .

All lines for water, cleaning fluids, hot steam, etc. are provided with corresponding control valves, which are connected to an electronic control system, not shown in the figures . Furthermore, pressure and / or temperature sensors are provided in the area of the outer drum 2 and in the area of some lines, which are also connected to the electronic control.

The operation of the device according to the invention or the sequence of the method according to the invention will now described below:

To load the inner drum 4 with the objects 74 to be cleaned, for example rubber stoppers or the like, the objects 74 are filled in the hopper 66 . The 3-way valve 64 is then switched so that there is a connection between the loading hopper 66 and the induction pipe 22 . By flushing water through the water inlet 68 , the objects 74 are conveyed from the hopper 66 into the induction pipe 22 and from there into the inner drum 4 . The valve 64 is then closed, so that the inner drum 4 is closed in a pressure-tight manner.

Thereafter, the cleaning and sterilization of the objects 74 begins. It is essential to the invention that the rinsing and sterilization process is linked to a common function. The heating jacket 24 is heated by supplying superheated steam through the line 62 . Since this is an indirect heating, ie because the steam cannot get into the interior of the drum 2 or 4 , the use of sterile steam is no longer necessary, but it can be used with any available steam, i.e. factory steam . By the heated heating jacket 24 , the Wan extension of the outer drum 2 is heated and thus also the standing in the inner drum 4 water 76 with the counter states 74 therein. The inner drum 4 is now rotated via the motor 8 and the shaft 6 , so that the spray tube 12 between the outer drum 2 and the inner drum 4 also runs synchronously with the inner drum 4 . The pump 36 now pumps water through the filter 38 both to the spray tube 12 and to the coaxially arranged fixed spray tube 18 , the spray tube 12 with its radially outwardly directed spray nozzles spraying the inner circumferential surface of the outer drum 2 and the spray tube 18 with its obliquely downward spraying nozzles spraying the objects 74 be, as can be seen in particular from Fig. 3.

The water kept particle-free by the filter 38 , which emerges from the spray nozzles of the spray tube 12 , evaporates on the wall of the outer drum 2 heated by the heating jacket 24 , so that a saturated vapor atmosphere of 121 ° C. builds up inside the drum 2 . Thus, while the objects are 74 sub aqual, ie cleaned below the water level 76, is effected simultaneously by the saturated steam over atmospheric pressure of 121 ° C sterilization of the Ge genstände 74th The water emerging from the spray pipes 12 and 18 is returned via the line 40 to the pump 36 , so that there is a closed circuit with an interposed filter 38 .

Due to the arranged on the inner circumferential wall of the inner drum 4 screw 14 and the inclined position of the outer and inner drums there is a uniform mixing of the objects 74 in which the inner drum 4 rotates, the objects 74 in due to the conveying characteristics of the screw 14 Fig. 1 and 2 are moved to the right. In order to prevent the objects 74 from jamming at the right end of the inner drum 4 in FIGS . 1 and 2 due to the conveying action of the screw 14 and the inclined position of the drums, the guide plate 16 is provided, which is arranged at the outlet area of the screw 14 and which aufstauenden articles 74 back supports in the transition region of the screw 14 at the outlet section of the screw 14, so that right on in Fig. 1 the end of the internal drum 4, a krei transmitting movement of the articles 74 obtained inside the inner drum 4.

After a certain period of time, the direction of rotation of the inner drum 4 is reversed, so that the objects 74 in FIGS . 1 and 2 are moved to the left, since the conveying direction of the screw 14 is now also reversed. As a result, the objects 75 present in piles at the right end in FIGS. 1 and 2 are again distributed over the entire axial extent of the inner drum 4 and in this case are wetted intensively by the spray tube 18 . The inclined position of the drums prevents the objects 75 from being moved too far to the left and from prematurely getting into the unloading cone 42 .

The saturated vapor overpressure atmosphere of 121 ° C. is maintained inside the drums 2 and 4 for at least half an hour in order to meet the requirements regarding sterilization. Here, the direction of rotation of the inner drum 4 is always reversed, so that by means of the worm 14 and the guide plate 16 an intensive movement and mixing of the counter states 74 takes place.

After cleaning and sterilization, the cleaning bath is drained. For this purpose, the inner drum is rotated into a position in which the spray tube 12 is at the lowest point. Due to the prevailing pressure in the outer drum, the ge required water is passed through the spray tube 12 and the hollow shaft 6 in the opposite direction through the filter 38 , so that it is backwashed and cleaned. This rinsing water then enters the cooler 56 and is gradually cooled here by adding cold water from the line 58 . About the jacket cooling line 60 this gradually cooling water is then fed to the heating jacket 24 , so that this and thus the entire pressure vessel is cooled from initially 121 ° C to 40 ° C. After pressure equalization with the atmosphere via a corresponding line and an optionally to be carried out intermediate step of Siliconisierens of the articles 74, the drying of the articles 74 occurs.

For this purpose, the valve 64 is switched so that a connection between the induction pipe 22 and the Luftzu drove 26 exists. Intake air passes through the Vorfil ter 28 , the fan 30 , the sterile filter 32 and the heater 34 and exits through the induction pipe 22 into the interior of the inner drum 4 . The air outlet takes place via the exhaust air opening 48 , which opens into the exhaust air duct 54 . Condensate that forms thereby enters the cooler 56 . During the supply of sterile warm air into the interior of the inner drum 4 , the inner drum 4 is rotated to enable the articles 74 to dry uniformly.

After the drying of the objects 74 and a possible intermediate step of siliconizing, the internal drum 4 is discharged. For this purpose, the inner barrel 4 is accelerator as Fig. 2 is rotated such that the screw 14, the articles in Fig. 2 moves 74 leftward be so that they finally get over the Entladekonus 42 and the opened lid 70 in a filling container 78, as shown in Fig. 2 shown. The supply of sterile warm air into the interior of the inner drum 4 stops undiminished, so that this sterile air emerges from the opened discharge cone 42 and thus prevents the ingress of particles during the filling process.

After removing the filled container 78 and closing the lid 70 , the device according to the invention is ready for the treatment of the next batch.

During the entire process, there is automatic monitoring of the pressure and temperature profile by means of the sensors arranged, with direct visual monitoring of the processes inside the inner drum 4 being possible further through a viewing window 80 with a built-in lighting source.

The device according to the invention and the method according to the invention are thus distinguished by the following features:
Compared to the prior art of the generic type, there is the considerable advantage that no manual intervention in the area of the inner drum 4 is necessary either during loading or unloading, and thus loading and unloading can be carried out virtually fully automatically without direct intervention in the treatment area.

By simultaneously cleaning and sterilizing the process time is shortened compared to conventional ones Systems by almost 50%.

For the operation, ie the heating, no sterile steam is necessary, since the heating of the pressure container takes place indirectly via the heating jacket 24 and not through sterile steam to be introduced into the pressure container.

Through the synchronous with the inner drum 4 rotating spray tube 12 , on the one hand, the generation of saturated steam atmosphere takes place inside the inner drum 4 , and further the inner peripheral wall of the outer drum 2 is continuously cleaned, so that no objects 74 cleaned from the objects can settle there.

Since the inner drum 4 is completely constantly emptied by the screw conveyor 14 , no batch mixing can follow it.

Due to the stationary spray tube 18 , the individual spray cones of the spray nozzles are constantly directed towards the objects 74 to be cleaned, as a result of which the cleaning effect is intensified.

By continuously filtering out the cleaned particles in the filter 38 , an optimal cleaning result is achieved. It is particularly advantageous here that the filter 38 is automatically backwashed by the relaxing water after the sterilization process has ended.

When drying the cleaned objects 74 , the air escapes into the inner drum 4 through the flushing tube 22 and thus directly onto the objects 74 and not through the perforation of the inner drum 4 from the outside. This means that drying is gentle and very efficient and fast at the same time. Particularly in connection with the heater 34 , extremely low residual moisture values of the objects 74 are achieved, which is absolutely necessary, for example in the case of lyophilization stoppers, ie closures for freeze-dried medicines.

By emptying through the discharge cone 42 with simultaneous access of sterile air through the flushing tube 22 there is no contamination of the cleaned objects 74 and the interior of the drums 2 and 4 by atmospheric particles. Furthermore, the sterile filling means that the device according to the invention can also be installed in non-sterile rooms.

Claims (15)

1. Device for cleaning, sterilizing and drying small objects, in particular pharmaceutical closure elements, with: a substantially closed outer drum ( 2 ), which is connected to supply and discharge lines for treatment fluids;
a heating jacket ( 24 ) for the outer drum ( 2 );
one in the outer drum ( 2 ) rotatably mounted, perforated inner drum ( 4 ) for receiving the Ge objects ( 74 );
a drive device ( 8 , 10 ) for the inner drum ( 4 );
an axially extending through the inner drum ( 4 ) he first spray tube ( 18 ) with a greater number of spray nozzles distributed along its length;
a second spray tube ( 12 ) arranged between the outer and inner drums, which rotates synchronously with the inner drum ( 4 ) and has a plurality of longitudinally distributed, radially outwardly pointing spray nozzles; and
at least one stirring element ( 14 ) arranged on the inner peripheral wall of the inner drum ( 4 ) for the objects, characterized in that
that the heating jacket ( 24 ) completely surrounds the outer drum ( 2 );
that the first spray tube ( 18 ) is stationary relative to the inner drum ( 4 ) and
that the stirring element ( 14 ) is designed in the form of a screw conveyor extending over the longitudinal extent of the inner drum ( 4 ). 2. Device according to claim 1, characterized in that a guide plate ( 16 ) is arranged at an outgoing end of the screw conveyor ( 14 ). 3. Apparatus according to claim 1, characterized in that the outer drum ( 2 ) is pressure-tight. 4. Device according to one of claims 1 to 3, there characterized in that the outer drum under Pressure can be set. 5. The device according to claim 4, characterized in that the outer drum ( 2 ) is pressurized by means of saturated steam. 6. The device according to claim 5, characterized in that the saturated steam is generated by evaporation of water on the inner peripheral wall of the outer drum ( 2 ). 7. Device according to one of claims 1 to 6, characterized in that the direction of rotation of the inner drum ( 4 ) relative to the outer drum ( 2 ) can be revered. 8. Device according to one of claims 1 to 7, characterized in that the heating jacket ( 24 ) is switchable in such a way that it draws heat from the inner drum. 9. Device according to one of claims 1 to 8, characterized in that the inner drum ( 4 ) can be automatically filled and emptied. 10. Device according to one of the preceding claims, characterized in that at least the inside drum at an angle of 3 to 5 ° to the horizon tal is inclined. 11. A method for cleaning, sterilizing and drying small objects, in particular pharmaceutical closure elements, with the following steps:

• a) introducing the objects into an inner drum rotatably arranged in a pressure-tightly closed, externally heatable outer drum together with a cleaning fluid;
• b) heating the outer drum;
• c) spraying the inner wall of the outer drum with water in such a way that a saturated steam atmosphere is created in the inner drum;
• d) rotating the inner drum such that a stirring element arranged in the inner drum reciprocates the objects in the longitudinal direction of the inner drum back and forth while simultaneously spraying the objects with a fluid from a stationary spray tube with a plurality of spray nozzles;
• e) maintaining step d) for at least 30 minutes;
• f) cooling the heating jacket to ambient temperature with simultaneous direct blowing of sterile air on the objects in the inner drum and
• g) emptying the inner drum by means of the Rührele element.

12. The method according to claim 11, characterized in that the stirring element in the form of one over the longitudinal stretching the inner drum conveyor snail is formed. 13. The method according to claim 11 or 12, characterized records that the outer drum inner wall by means of one rotating synchronously with the inner drum Spray tube is sprayed. 14. The method according to claim 11 to 13, characterized records that at an end of the För derschnecke a baffle is arranged. 15. The method according to any one of claims 11 to 14, there characterized in that the direction of rotation of the In drum is reversible.