Ultra clean cleaning process for radiopharmaceutical reusable pigs

Abstract

A process for cleaning reusable canisters known as pigs which contain radioactive drugs and may contain residual radioactive material and other contaminants. Those pigs that are contaminated with radio-active material are removed from the cleaning process until they have decayed to the background radiation level, cleaned and disinfected. Within a very clean drug preparation area a radioactive drug is inserted into the pig and the pig is placed in a protective outer container. At a treatment site the outer container and pig are delivered to a clean treatment area where the pig is removed from the outer container and the drug is removed from the pig and utilized.

Claims

1. In a process for cleaning a radiopharmaceutical reusable pig having a lower portion, a cap, and a syringe or vial containment enclosure, comprising the steps of: scanning the pig with a radiation detection device to detect the presence of radioactivity at a radiation level above background level; upon detecting the presence of radioactivity at said radiation level, causing said pig to cease exhibiting said radioactivity; and sanitizing the pig to destroy any microorganisms and remove any blood contamination from said pig; the improvement comprising the additional steps of: transporting the ceased exhibiting radioactivity and sanitized pig to a drug preparation area suitable for dispensing a drug for human use; within the drug preparation area, inserting a syringe or vial containing a radioactive drug into the containment enclosure and assembling the cap to the lower portion of the pig; within the drug preparation area, placing the assembled pig containing the drug, in a protective outer container to protect the pig from external contamination during handling and transportation; and placing the protective outer container containing the pig, in a transportation receptacle.

2. The improvement according to claim 1, comprising the additional step of sterilizing or sanitizing the pig after said pig is in the drug preparation area and prior to inserting a syringe or vial into the containment enclosure thereof.

3. The improvement according to claim 1, comprising the additional step of sterilizing or sanitizing the protective outer container before the pig is placed within it.

4. In a process for cleaning a radiopharmaceutical reusable pig having a lower portion, a cap, and a syringe or vial containment enclosure, comprising the steps of: scanning the pig to detect the presence of radio-activity at a radiation level above background level; upon detecting the presence of radioactivity at said radiation level, causing said pig to cease exhibiting said radioactivity; and sanitizing the pig to destroy any microorganisms and remove any blood contamination from said pig; the improvement comprising the additional steps of: transporting the ceased exhibiting radioactivity and sanitized pig to a drug preparation area suitable for dispensing a drug for human use; sterilizing or sanitizing the pig after said pig is in the drug preparation area; within the drug preparation area, inserting a syringe or vial containing a radioactive drug into the containment enclosure and assembling the cap to the lower portion of the pig; within the drug preparation area, sterilizing a protective outer container for the pig; within the drug preparation area, placing the assembled pig containing the drug, in the protective outer container to protect the pig from external contamination during handling and transportation; and placing the protective outer container containing the pig, in a transportation receptacle.

5. The improvement according to claim 4, comprising the additional steps of: delivering the transportation receptacle to a drug utilization facility; at said facility, removing the outer container from the transportation receptacle; delivering the removed outer container to a drug utilization area within the facility; and within the drug utilization area, sterilizing the protective outer container before removing the pig from the container.

Description

IN THE DRAWING

(1) The FIGURE is a diagram showing the steps in a preferred embodiment of the process of the invention.

DETAILED DESCRIPTION

(2) Referring to the FIGURE, a spent pig containing used syringes and vials is returned to the pharmacy. At Step 1 the pig is processed according to the Prior Prosser Patent to reduce any radiation from it to background level and to remove contaminants and microorganisms.

(3) At Step 2 the cleaned, radiation-free pig is transported to a drug preparation area suitable for dispensing a drug for human use. Such an area is usually a clean room with filtered air, or a laminar flow hood.

(4) At Step 3, the already sanitized pig may be sanitized a second time while it is in the drug preparation area. Sanitization may be accomplished by placing the pig in an autoclave, high temperature wash, a chemical wash, or by any other suitable method that will destroy microorganisms. This step may be omitted if the resulting slightly lower level of cleanliness is acceptable for the place of use. For example, a nuclear medicine department in a hospital might not require the level of cleanliness that the operating room requires.

(5) At Step 4 while still in the drug preparation area, a syringe or vial containing a radioactive drug to be utilized at a treatment site, including a site that requires a higher level of cleanliness such as an operating room, surgical suite, or interventional procedure suite, is inserted into the lower portion of the pig and the pig cap is assembled to the lower portion thereof.

(6) At Step 5, while still in the drug preparation area, the assembled pig containing the drug syringe or vial is placed in a protective outer cover to protect the pig from external contamination during transportation.

(7) The protective outer cover is preferably a self sealing pre-sterilized sterility maintenance cover or bag which is intended to cover wrapped or enclosed items after sterilization to provide protection from environmental factors which could compromise sterility. A suitable Sterility Maintenance Cover is made of a medical grade polyolefin material such as polyethylene and is commercially available from General Econopak, Inc., 1725 North Sixth Street, Philadelphia, Pa. 19122 under Reorder No. 3315ST.

(8) At Step 6 the protective outer container containing the pig and drug syringe or vial is placed in a federal Department of Transportation approved transportation receptacle for delivery to the place where the drug is to be used.

(9) At the destination, the protective outer container (still containing the pig and drug syringe or vial within the pig) is removed from the transportation receptacle and delivered to a utilization site which may be an operating room, surgical suite or interventional procedure room, or other area designated as a clean environment. While in that area, the outer container is removed, the cap is removed from the pig, and the syringe or vial is removed and utilized. Therefore the syringe or vial is, at all times that it is associated with the pig, kept in a protected clean environment.

(10) For an even higher level of protection, the protective outer container can be sanitized at the site of use prior to the user touching it. Then the pig can be removed from the outer container, to expose the ultra clean pig.