Note: Descriptions are shown in the official language in which they were submitted.
Process and device for the thorouqh cleaninq a~d~
sterilization of pharmaceutical rubber stoppers
The invention relates to a process for the thorough
cleaning and sterilization of rubber stoppers in
pharmaceutical factories, in which the stoppers are washed
and then introduced into a steam sterilizer for
sterilization.
o Before rubber stoppers are used as closing elements for
bottles containing pharmaceutical preparations, they have
to be cleaned and sterilized. In a known stopper washing-
sterilizing machine, the rubber stoppers are charged into
a perforated drum, which is placed in a steam sterilizer.
In the steam sterilizer, the stoppers are washed, rinsed,
sterilized and then dried. The stoppers are subsequently
transferred to a storage container. Apart from the fact
that the sterilization is carried out in a relatively
expensive, special sterilizer, transfer of the cleaned and
sterilized stoppers carries the risk of recontamination.
The object of the invention is to simplify the procedure
for the cleaning and sterilization of pharmaceutical
rubber stoppers and to reduce the risk of contamination on
further handling.
This object is achieved according to the invention by a
process in which the rubber stoppers are thoroughly
cleaned with ultrapure water in a multipurpose container
equipped with connecting valves for washing water, the
multipurpose container with the thoroughly cleaned
stoppers is placed in a steam sterilizer, in which the
stoppers are sterilized and dried, and, after
sterilization and drying, the stoppers are held in reserve
in the same multipurpose container without a transfer
process.
Le A 28 570
In a preferred embodiment, the multipurpose conta~ 41
filled with the rubber stoppers under laminar flow
protection before the washing and sterilization process.
The multipurpose container for carrying out the process
according to the invention is characterized in that two
connecting valves for water are provided on the container
for feeding the container with washing water and emptying
it, and in that at least one water-permeable stopper
retaining plate is arranged inside the container.
Thus the transport, cleaning and sterilization of the
rubber stoppers and the storage of the rubber stoppers at
the filling machine take place in one multipurpose
container without transfer manipulations. The
sterilization can be carried out in a conventional, easily
modified steam sterilizer. These sterilizers can then
also be used for other sterilization purposes.
Simplification of the procedure markedly reduces the risk
of recontamination.~ The multipurpose container fulfils
several functions:
- It serves as a transport container with a protective
function in respect of the surroundings, for the
reception of brand-new rubber stoppers supplied with
a relatively high degree of cleanliness.
- The stoppers are thoroughly cleaned, sterilized and
dried in the same container.
- The container then serves again as a transport
container in the sterile sector of a pharmaceutical
production.
Le A 28 570 2
2 ~
- At the bottle filling and stoppering machine, the
container serves as a storage container from which the
required stoppers can be taken automatically.
The invention is illustrated in greater detail below with
the aid of a drawing and an Example. The multipurpose
container for pharmaceutical rubber stoppers, shown in the
drawing, consists of a stainless steel can l with a cover
2 for closing the charging and discharging orifice 3.
Connectors with shut-off valves 4 and 5, for washing
water, are arranged at the top end and at the bottom of
the can 1. A stopper retaining plate 6 is fixed just
above the bottom of the can 1, directly over the shut-off
valve 4. It consists of a perforated plate (sieve) whose
holes are substantially smaller than the diameter of the
stoppers. A similar but substantially smaller perforated
plate 7 is arranged in the cover 2 of the can and prevents
stoppers from reaching the upper water connector with the
shut-off valve 5-.
" ~)
The novel thorough cleaning and sterilization process
proceeds for example as follows:
1. Charging of the multipurpose container 1 (can 1) with
the rubber stoppers under a laminar flow device
(corresponding to clean-room class 3, VDI 2083, in
surroundings of cleanliness class VDI 2083);
2. Connection of the can 1 via the shut-off valves 4 and
5 to a cleaning station, also under clean-room class
3, VDI 2083;
3. Opening of the connecting valves 4, 5;
Le A 2B 570 3
83~1
4. Overflow rinsing with ultrapure water having the
particle quality of aqua p. io according to DAB, for 10
minutes at 45OC;
5. Draining of the water out of the can 1;
6. Closing of the connecting valves 4, 5;
7. Transporting of the can 1 into the steam sterilizer;
8. Connection of the can to a rotary device in the steam
sterilizer;
9. Opening of the connecting valves 4, 5;
10. Sterilization of the stoppers by a conventional
fractional backing pressure process with constant or
alternating rotation of the can for a period of 15
minutes at temperatures 2121C;
11. Drying of the stoppers by a conventional vacuum drying
process with constant or alternating rotation of the
can;
12. Closing of the connecting valves 4, 5;
13. Withdrawal of the can 1 from the sterile side of the
sterilizer.
Le A 28 570 4
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