System for sterilizing medicinal products by beta-radiation processing

• US 6,177,677 B1
• Filed: 04/13/1999
• Issued: 01/23/2001
• Est. Priority Date: 12/17/1996
• Status: Expired due to Fees

• Current Assignee: Gambro Hospal Schweiz AG (Baxter International Inc.)
• Original Assignee: Hospal AG (Baxter International Inc.)
• Inventors: Santi, Marco, Alboresi, Luigi
• Primary Examiner(s): Anderson, Bruce C.
• Application Number:
  US09/125,229
• Time in Patent Office: 651 Days
• Field of Search: 250/453.11, 250/454.11, 250/492.1
• US Class Current: 250/453.11
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail

Abstract

A system is provided for sterilizing, by irradiation, a plurality of products, each product having an identification code. The products are carried on product carriers which include a carrier identification code. The system includes a product loading station, a product unloading station, an irradiation blocking containment, and an irradiation station location located within the containment. A conveyor passes from the loading station through the containment to the unloading station. Code readers are located along the conveyor for detecting and reading both the product identification code and the carrier identification code. A control and monitoring circuit receives the codes, and stores in memory an association between specific carriers and the products located on those carriers.

Claims

1. Method for the sterilization of medical products by irradiation, comprising the steps of:

placing at least one product provided with a product identification code onto a tray provided with a tray identification code;

reading the tray identification code and the product identification code;

storing the combination of the tray and product identification codes;

conveying the tray along a definite path towards an irradiation station;

sterilizing said at least one product at the irradiation station; and

locating the tray by reading the tray identification code at definite places along the path.

2. Method according to claim 1, further comprising the steps of:

comparing the read product identification code with the identification code of the product previously stored, and, if the products are not of the same type;

blocking the travel of the tray on which the product is placed;

placing a device for measuring the irradiation dose generated by the irradiation station onto a second tray;

setting the irradiation station so that it emits radiation suitable for sterilizing the product;

conveying the tray towards the irradiation station;

measuring the radiation dose received in the irradiation station by means of the measuring device; and

monitoring the measured radiation when the second tray has emerged from the irradiation station.

15. Installation according to claim 1, further comprising a trelliswork cage surrounding the conveyance means outside the containment.

3. Installation for the sterilization by irradiation of a plurality of medical products, each product having an identification code affixed thereto, the installation comprising:

at least one product loading station;

at least one product unloading station;

an irradiation station located inside a containment having walls capable of stopping sterilizing radiation;

conveyance means for conveying the products to be sterilized from the loading station to the irradiation station and the sterilized products from the irradiation station to the unloading station;

a plurality of trays for supporting the products on the conveyance means, each tray being provided with an identification code;

code-reading means, arranged along the conveyance means, for reading the code affixed to each tray and the code affixed to each product; and

control and monitoring means connected to the code-reading means for combining and storing the identification code of each product and the identification code of the tray supporting each product, and for following the travel of the products on the conveyance means.

4. Installation according to claim 3, further comprising mechanical travellimit detection means arranged inside the containment, in order to detect the position of the trays inside the containment and transmit a corresponding signal to the control and monitoring unit.

5. Installation according to claim 3, further comprising code-reading means arranged in the vicinity of the loading station, the control and monitoring means including means for comparing each product introduced in the loading station with a product previously introduced and for controlling a triggering of warning means when these products are not of the same type.

6. Installation according to claim 3, wherein the conveyance means comprises grouping means for grouping the products to be sterilized in the vicinity of the irradiation station.

7. Installation according to claim 3, wherein the grouping means comprises a first conveyor and a second conveyor, the second conveyor being located immediately downstream of the first conveyor in relation to the direction of conveyance of the products and having a conveying speed lower than the conveying speed of the first conveyor.

8. Installation according to claim 7, wherein the first and second conveyors comprise retractable drive members for catching the products and strictly subjecting their displacement to that of the corresponding conveyor.

9. Installation according to claim 7, wherein the second conveyor comprises two half-conveyors separated by a gap located in a zone towards which the irradiation station emits sterilizing radiation.

10. Installation according to claim 7, further comprising a third conveyor located immediately downstream of the second conveyor in relation to the direction of conveyance of the products, the third conveyor having a conveying speed higher than the conveying speed of the second conveyor.

11. Installation according to claim 7, wherein at least the first and second conveyors are chain conveyors, each comprising a pair of chains and in that the drive members each comprise a finger and are mounted pivotably on the chains, so as to be capable of pivoting between a retracted position, in which the finger cannot catch any product, and a projecting position, in which the finger can catch a product.

12. Installation according to claim 7, further comprising means for measuring a speed of the second conveyor, wherein the measuring means is connected to the control and monitoring means, and the control and monitoring means is configured to adjust the irradiation station as a function of the variations in the speed of the conveyor, in such a way that the products receive a predetermined irradiation dose.

13. Installation according to claim 3, wherein the conveyance means comprises superposed conveyance sections, the conveyance sections located at a first level conveying products to be sterilized from the loading station to the irradiation station, and the conveyance sections located at a second level conveying sterilized products from the irradiation station to the unloading station.

14. Installation according to claim 13, wherein the conveyance means comprises a vertical transporter for transferring the products from one conveyance level to another conveyance level.

16. A system for sterilizing, by irradiation, a plurality of products, each product having an identification code thereon, and being carried through the system on a carrier, each carrier having an identification code thereon, the system comprising:

at least one product loading station;

at least one product unloading station;

a containment having walls for blocking sterilizing radiation;

an irradiation station located within the containment;

at least one conveyor defining a travel path between the product loading station, the irradiation station and the product unloading station;

at least one carrier code reader arranged along the conveyor, the carrier code reader being configured to detect and read carrier identification codes and for outputting carrier code data;

at least one product code reader arranged along the conveyor and being configured to detect and read product identification codes and for outputting product code data; and

a control and monitoring circuit for receiving carrier code data and product code data, for storing in memory an association between specific carriers and product located thereon, and for monitoring travel of the products along said at least one conveyor using carrier code data.

17. The system of claim 16, wherein the control and monitoring circuit is configured to associate particular products with particular trays upstream of the containment and wherein locations of the particular products with the containment are monitored by tracking tray identification codes.