WO2005065728A1 - Method and apparatus for validation of sterilization process - Google Patents
Method and apparatus for validation of sterilization process Download PDFInfo
- Publication number
- WO2005065728A1 WO2005065728A1 PCT/US2004/040146 US2004040146W WO2005065728A1 WO 2005065728 A1 WO2005065728 A1 WO 2005065728A1 US 2004040146 W US2004040146 W US 2004040146W WO 2005065728 A1 WO2005065728 A1 WO 2005065728A1
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- WIPO (PCT)
- Prior art keywords
- dosimeter
- sterilization
- component
- block
- assembly
- Prior art date
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- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 151
- 238000000034 method Methods 0.000 title claims abstract description 45
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- 238000010200 validation analysis Methods 0.000 title description 15
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/24—Apparatus using programmed or automatic operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/12—Apparatus for isolating biocidal substances from the environment
- A61L2202/122—Chambers for sterilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Definitions
- the present invention relates generally to the field of automated inspection, staging, and assembly of pre-sterilized components, specifically medical components, to maintain sterility via a low-energy electron beam field.
- E-beam sterilization unit size and cost were two big factors feeding the move toward low- energy sterilization systems. Depth of the sterilizing radiation penetration became the tradeoff. Where high-energy systems may achieve penetration depths of over a meter, low- energy beams are limited to penetration depths of as low as only a few microns. The significantly reduced radiation penetration of low-energy electron beams used for medical device sterilization raised the issue of sterility validation as a processing concern. The FDA requires that "all processes used to produce medical devices be validated" (21 C.F.R. ⁇ 820.752), including E-beam sterilization.
- SAL sterility assurance level
- the present invention provides an apparatus for use in the validation of low-energy electron beam sterilization systems. Furthermore, the invention provides a method that cost-effectively and reliably provides for the routine dosimetric monitoring of the sterilization process for low-energy electron beam sterilization systems.
- the present invention comprises a method and apparatus for verifying the radiation dose delivered to achieve the sterilization of components, such as medical devices, in a low-energy electron beam sterilization system.
- a single-site dosimeter assembly is disclosed.
- the assembly is comprised of a first component block having a cavity, suitable for positioning a dosimeter therein, and a coaxially configured passage to allow for the travel of radiation into the cavity portion.
- a second component block affixes to the first block and comprises an interior surface with a protrusion configured to abut an interior surface of the cavity, thereby retaining the dosimeter therein.
- the assembly may further comprise a mechanism to affix the first dosimeter block to the second dosimeter block, and affix the resulting assembly to a.radiation sterilization site.
- a method for verifying sterilization of components in a low-energy electron-beam sterilization system is also described.
- the novel method comprises the steps of placing a component within a low-energy electron-beam sterilization system as a site to be sterilized, designating an indicator site within the sterilization system as a site to be used to indicate achievement of a dose level, determining a sterilization dose level which when achieved results in a desired sterility assurance level (SAL) of a component, establishing a correlation between a dose achieved at the indicator site and a dose achieved at the sterilization site, exposing the designated sites to a sterilizing source to achieve a sterilization dose at the sterilization site and a correlated dose at the indicator site, determining the dose achieved at the indicator site, and ascertaining the efficacy of the sterilization dose achieved at the sterilization site based on the determined dose at the correlated indicator site.
- SAL sterility assurance level
- the step of establishing a correlation comprises the steps of exposing the designated sites to a sterilizing source to mimic operation of a sterilization system, measuring the sterilizing dose received at each site, and repeating exposing and measuring steps to determine a relationship between the sterilizing dose level measured at a sterilizing site and a sterilizing dose level measured at an indication site.
- An assembly capable of verifying sterilization of two components to be connected together is also disclosed.
- the assembly comprises a first component carriage and a second component carriage.
- Each carriage preferably comprises a component site requiring a threshold sterilization dose to achieve sterility of a component, and a dosimeter site positioned approximate the component site and having a dosimeter to receive an applied dose which corresponds to a sterilization dose level received by the component site. It is important to note that the dose ultimately achieved at the indicator site is not necessarily equal to that achieved at the sterilization site, nor is it necessary that the dose at the indicator site even be a sterilizing dose.
- the first component carriage further comprises a mechanism to control the sterilization dose received by the dosimeter at the dosimeter site.
- the mechanism in one embodiment comprises a passage having a diameter and a depth, with the passage being positioned above the dosimeter site.
- the diameter and depth of the passage may be of any suitable sizes to allow for the proper amount of radiation exposure.
- the assembled dosimeter site preferably comprises a first holder block having a receptacle defined within a wall of the holder block to contain a dosimeter therein, and an passage, having a diameter and depth, through the wall within the periphery of the receptacle, and a second holder block configured with a mating section which fits within the receptacle of the first holder block to abut the dosimeter therein.
- the first component carriage may comprise from 1 to 10 component sites and from 1 to 15 dosimeter sites.
- FIGURE 1 is a perspective view of the backside of a bag sterilization pallet having attached thereto one embodiment of the present dosimeterholder of the present invention
- FIGURE 2 is a back elevation view showing an embodiment of the present invention attached to the bag sterilization pallet of FIGURE 1
- FIGURE 3 is a top view showing one embodiment of a multi-site dosimeter holder attached to the bag sterilization pallet of FIGURE 1
- FIGURE 4 is a side elevated view of one embodiment of a dosimeter holder attached to the bag sterilization pallet of FIGURE 1, including a medical solution bag and vial/device shown
- FIGURE 5 is an exploded view of one embodiment of a multi-site dosimeter holder of the present invention
- FIGURE 6 is a cross-sectional view of the assembled embodiment of the dosimeter holder shown in FIGURE 5
- FIGURE 7 is a plan view of the second or upper block of the embodiment shown in
- Sterility Sterilize, Sterilization, etc., the act of using or condition achieved after use of a physical or chemical procedure to destroy microbial life, including pathogens such as highly resistant bacterial endospores and viruses
- Sterility assurance level SAL
- Low-Energy Electron-Beam an electron beam or beam array which operates at an energy of less than 300 KeV, more preferably in the range of from about 60 to about 150
- KeV sterility assurance level
- Verification of Sterility a process for determining that a desired component was exposed to the proper amount of radiation to achieve sterility
- Dosimeter any device that, when irradiated, exhibits a quantifiable change in some property of the device that can be related to absorbed dose in a given material using appropriate analytical instrumentation and techniques
- Component any medical device capable of being sterilized, such as, for example, drug vial, syringe, reconstitution device, medical tubing, IN bag, cannula, and the like
- Pallet or Carriage
- the prior art discloses methods and apparatus for the verification of ultraviolet sterilization (U.S. Patent No. 6,475,433 to McGeorge et al.) and thermal sterilization (U.S. Patent No. 6,340,590 to Gillis). Verification of sterilization in a low-energy electron beam system, however, provides far different challenges to those skilled in the art, as the following specification will address. Accordingly, the present invention involves methods and apparatus for automatically verifying sterilization of components, particularly where two or more components are to be connected in a sterile field. While the components may be made from any known material, preferably the objects are made from a readily sterilizable material.
- a glass drug vial may be sterilely connected to a rigid plastic reconstitution device to form a vial/device assembly (VDA).
- VDA vial/device assembly
- the assembly may then be sterile-connected to a flexible tubing portion of a fluid bag to form a final assembly.
- VDA vial/device assembly
- Such a vial/device assembly (VDA) and final assembly are shown in the appended drawings and described herein.
- the claimed invention should not be limited to these embodiments, which are included for exemplary purposes only.
- the components are received into a sterilization pallet utilizing the present invention for verification.
- Sterilization pallets are used to house, transport, and, in some cases, shield portions of the components as they move within a sterilization system.
- FIGURES 1-18 some example sterilization pallets can be seen.
- FIGURES 1-4 illustrate a bag pallet 70a.
- FIGURES 9-12 illustrate a vial and device pallet 70b.
- the bag pallet 70a is preferably a metal structure which functions to maintain at least one bag component in position for connection to at least one other component while at least a portion of those components are maintained within an electron beam field.
- the vial and device pallet 70b is preferably a substantially metal structure that also functions to position components for connection while being maintained within an electron beam field.
- the bag pallet 70a is generally designed to grip and retain, via grippers 75, the tubing of as many as four medical solution bags (SB) and four vial/device assemblies (VDA) (see FIGURE 4), as illustrated in FIGURE 1.
- SB medical solution bags
- VDA vial/device assemblies
- the open end of the tubing of each medical solution bag (SB) would be aligned with an end of one of the vial/device assemblies (VDA). While these components are pre-sterilized, it is desired to make the connection between the tubing end and the vial/device in a manner that maintains the sterility.
- the position on the pallet 70a where the component resides is called the component site 73.
- the position of the component end determines the component site 73.
- the ends of the two components to be connected together are maintained in such close proximity to one another that only a single component site 73 exists for each component pair.
- alternate configurations are possible.
- four cartridges 77 are shown configured to carry reconstitution devices (RD), while the vial holder 71 is shown to be configured to contain four inverted drug vials. It is similarly desirable to create a sterile connection between these components to create four complete vial/device assemblies (VDA) for later use in connecting to a sterile medical solution bag. Additional pallet designs may be contemplated for carrying other medical components for sterilization.
- each pallet is designed to expose the retained components to the active sterile field created by the low-energy electron beam.
- Bag pallet 70a permits the sterilizing electron beam to pass through a window 41.
- additional separate shielding may be provided in the sterilization booth for the exposed portions of, for example, the bag (SB) and vial/device assembly (VDA).
- SB bag
- VDA vial/device assembly
- the remaining portion of the components is preferably shielded by either the pallet or an alternative means within the sterilization booth.
- the component ends are then connected together through the actuation of at least one of the ⁇ components toward the other component. Movement of the components should be limited to the constraints of the electron-beam field until a proper connection is completed.
- a key aspect of the present invention is the ability to initially validate sterilization of exposed components at a specific dose level. It is a further feature of the invention to provide routine dose monitoring of the sterilization process. The use of routine radiation monitoring devices such as dosimeters for processing have been used for many years and are widely recognized and understood in the industry.
- the dosimeter is a radiochromic film.
- the monitoring fixture is placed such that the dose to which the dosimeter film is exposed will be approximately relative to the dose the product receives.
- the dosimeter placement is referred to as the indicator site.
- FIGURES 13 and 14 illustrate different halves of a basic single-site dosimeter holder 10, while the assembled fixture is shown in FIGURES 19(a) and 19(b).
- FIGURES 5-8 illustrate a multi-site dosimeter holder 40(a) for attachment to the bag pallet 70a of FIGURES 1-4.
- FIGURES 15-18 illustrate a multi-site dosimeter holder 40(b) for attachment to the vial and device pallet 70b of FIGURES 9-12.
- the respective dosimeter holder or fixtures shown are each comprised of a basic plate configured to be attached to a pallet — either a bag pallet or vial/device pallet.
- the plate can be a single metal plate or devised of any number of connectable parts. It may house as few as a single dosimeter, such as a dosimeter film, or a plurality of such devices for a particular holder. Referring to FIGURES 13, 14 and 19, halves of the single-site dosimeter holder 10 are shown.
- the holder 10 (when assembled) is comprised of a first dosimeter block 12 (FIGURE 14) and a second dosimeter block 14 (FIGURE 13).
- the first block 12 comprises an interior surface 16 with a substantially square cavity 18 defined therein, and an outer surface 20 with a cylindrical passage 22 to the cavity 18 passing therethrough.
- the cavity 18 may be of any desired shape to accommodate a radiochromic film dosimeter, which typically comes as a small square piece — though other shapes and sizes may be more suitable for alternative embodiments.
- the embodiment of FIGURE 14 also illustrates four radiused corner notches 24 extending from the cavity 18. These notches 24 facilitate the removal of the radiochromic film dosimeter from the cavity 18.
- the passage 22 may also be machined to various shapes, if desired.
- the passage 22 may be in the second dosimeter block 14 or pass through an adjacent side of the dosimeter block.
- the second dosimeter block 14 of FIGURE 13 comprises an interior surface 26 with a protrusion 28 configured to abut an interior surface of the cavity
- a radiochromic film dosimeter 30 is positioned within the cavity 18 of the first block 12 and held in place by the protrusion 28 of the second block 14.
- a first mechanism (not shown), such as a pin, bolt, or similar device, is used to pass through aperture 79 to affix the first dosimeter block 12 to the second dosimeter block 14 to form a dosimeter holder or assembly 10 (FIGURE 19).
- a second mechanism such as a pin, bolt, or similar device
- the dosimeter holder 10 may be used to affix the holder 10 to a radiation sterilization site, such as a component pallet.
- the first mechanism may perform the operation of the second mechanism for certain applications.
- the material used for manufacturing the dosimeter holder 10 must be radiation resistant and be of sufficient density and thickness to shield the contained dosimeter 30 from indirect exposure to the electron beam. Overexposure of the dosimeter 30 is a concern as it will negatively affect validation and routine monitoring.
- the size of the diameter and depth of the passage 22 may be adjusted. The larger the diameter of the passage 22 and the shorter the depth of the passage 22 (i.e., the thickness of the block material) the greater the dose the dosimeter 30 will receive. Conversely, the smaller the diameter and the longer the depth of the passage 22, the lower the dose received by the dosimeter 30.
- the passage depth is machined to 0.124 inch (3.15 mm) and the diameter is
- the passage depth preferably falls within the range of from about 0.070 to about 0.175 inch (1.78 - 4.45 mm), while the preferred diameter is within the range of from about 0.175 to about 0.290 inch (4.45 - 7.37 mm).
- the assembly 10 as well as varied dosimeter thicknesses and surface areas, there exists an infinite combination of diameters and depths of the passage 22 which may be used without departing from the intended purpose of the present invention.
- FIGURES 5-8 an embodiment of a multi-site dosimeter holder 40a for the bag pallet may be more readily seen and understood.
- the multi-site holder is comprised of a first block 46 and a second block 48.
- the illustrated embodiment is designed with four dosimeter sites 50 equally spaced along the length of the holder 40a.
- the number of dosimeter sites 50 may vary with the number of component sites 73 (see FIGURES 3 and 4) provided for in the component pallet 70, though an exact one-to- one correlation is not necessary.
- a greater number of dosimeter sites 50 per component sites 73 (e.g., 2:1, 4:1, etc.) may improve (or be necessary for) validation and routine monitoring.
- the first block 46 of the multi-site holder 40a differs from that of the single-site holder 10 in other ways.
- a cavity 18 for containing a radiochromic film dosimeter 30 is present, but there is no passage to the cavity in the first block 46. Rather, the second block 48, while comprising a protrusion 28 to fit within the cavity 18 of the first block 46 and retain the dosimeter therein, has a passage 22 through the protrusion 28.
- the function and the range of dimensions of the passage diameter and depth are otherwise identical to those of the.passage 22 in the single-site dosimeter holder 10.
- alternative embodiments may include the passage 22 on the first block 46 requiring only different positioning of the holder 40a on the pallet 70a. As shown in the cross-section of FIGURE 6, the first and second blocks, 46 and 48, are secured together to form a multi-site holder 40a.
- each dosimeter site 50 of the holder 40a is positioned to correspond to a component site 73 (FIGURE 2) on the frontside 74 of the pallet 70a.
- a component site 73 (FIGURE 2) on the frontside 74 of the pallet 70a.
- more than one dosimeter site may be used to correspond to a single component site, or vice versa.
- more than one holder 40a may be employed on each pallet 70a — for example, one on the frontside and one on the backside of the pallet, or one for the first component and one for a second component held on the pallet.
- FIGURES 15-18 another embodiment for a multi-site dosimeter holder, holder 40b is illustrated.
- This holder 40b has a 5:4 dosimeter site 50 to component site 73 ratio. While the holder 40b is shaped notably different than the bag pallet dosimeter holder 40a of FIGURES 5-8, the dosimeter sites 50 between the two embodiments are actually identically configured.
- the alternative embodiments disclosed for holder 40a also may be utilized for holder 40b.
- FIGURES 9-12 illustrate the attachment of the holder 40b to the vial/device pallet 70b in a position which places the dosimeter sites 50 proximate the component sites 73. Each component site 73 is sandwiched between two dosimeter sites 50 for improved validation.
- One of the first steps in the validation process is to determine the sterilization dose to product required to achieve the desired SAL.
- One of two approaches is taken in selecting the sterilization dose: selection of sterilization dose using either bioburden information or information obtained by incremental dosing; or using a sterilization does of 25 kGy following substantiation of the appropriateness of the dose.
- the minimum radiation dose can be achieved in several ways known by those skilled in the art, including increasing the intensity (current) of the electron beam or by increasing the time that the product is in the electron beam field.
- the next step is to determine the dose distribution of the product being sterilized.
- the dose distribution study or dose mapping is performed to identify the zones of minimum and maximum dose within the product(s) processed and to assess the reproducibility of the process.
- This information is then used to select the routine monitoring position for routine processing. That is, a location for the routine monitoring dosimeter must be determined such that during sterilization the level of radiation absorbed by the dosimeter (which is readily measurable) is proportional to that of the component to be sterilized (which is not readily measurable).
- the correlation between the dose received by the product and the dose received by the dosimeter is difficult to achieve because of complex product geometries and the tendency of the dosimeter to be saturated in the direct path of the electron field.
- a preferred embodiment of the system for sterile connecting a plurality of components comprises a sterilization chamber 112 having a low- energy electron beam source 102, and a component pallet 70 capable of positioning at least two components within a sterilizing cloud created by the low-energy e-beam source within the sterilization chamber 112.
- a transportation source (not shown), such as a conveyor belt or indexing table, may be used to convey the component pallet 70 from a staging area to the sterilization chamber 112.
- the sterilization chamber 112 is preferably situated as a center compartment within a larger sterilization booth 110.
- the preferred sterilization system is comprised of two booths: a bag sterilization booth 110a (FIGURE 21) and a vial/device sterilization booth 110b (FIGURE 23).
- the two booths, 110a and 110b are identical in purpose, so the following discussion will merely refer to bag sterilization booth 110a. However, where key differences exist between the booths, such differences will be noted in this text and the appended drawing figures.
- the two booths 110a and 110b are divided into three chambers: a pre-sterilization chamber 114, the sterilization chamber 112, and a post-sterilization chamber 116. Each chamber is comprised of a set of entrance doors and a set of exit doors.
- the exit doors 131 for the pre-sterilization chamber 114 also act as the entrance doors for the sterilization chamber 112.
- the sterilization chamber exit doors 132 also function as the post- sterilization chamber 116 entrance doors.
- the doors are preferably laterally sliding doors actuated by, for example, a hydraulic mechanism reacting to a sensor (not shown) and control system (not shown). As space allows, the doors may be designed to slide vertically or horizontally. A single panel or bi-parting panels may be used as well. These added features and their implementation would be well-understood by those skilled in the relevant art of automated system design.
- the four sets of chamber doors 130, 131, 132, and 133 are comprised of a one-inch lead core with a quarter-inch stainless steel exterior lining.
- the chamber walls 134 are built to prevent accidental exposure of external personnel to radiation created by the electron beam source. Use of higher energy sources may require additional shielding.
- the sterilization chamber 112 should also be comprised of an appropriate ventilation means due to the creation of ozone from these energy sources.
- the e-beam source is preferably provided by two oppositely positioned low-energy electron beam tubes 102. Presently, there only are a small number of suppliers for such tubes. Tube and beam dimension and output operating parameters are only a few factors which may guide selection.
- the preferred e-beam tubes for the present embodiment are approximately ten-inches in width and two-inches in height, and operate in the range of 60 to 125 KeV.
- the components could be rotated within the resulting electron cloud to effect sterilization, or the source beam could revolve about the components for the same effect.
- any number of electron beams may be used in an array fashion to further address shadowing of very complicated connections or oddly shaped components. Referring now to FIGURE 20A-C, the movement of pallets 70 through the three chambered booth 110 can be more readily understood. Beginning with a completely empty booth 110, the door 130 into the pre-sterilization chamber 114 is opened. Here the first component pallet 70' is held until the door 130 is again closed.
- door 131 is opened and the first component pallet 70' enters the sterilization chamber 112
- the door 131 is completely closed, and door 130 is opened to permit the entrance of a second component pallet 70", as shown in FIGURE 20A.
- the first component pallet 70' is subject to sterilization, the details of which will be explained in greater detail below.
- the door 130 is then closed as before, while door 132 is opened to allow the movement of the first component pallet 70' to the post-sterilization chamber 116.
- door 131 is opened to allow the second component pallet 70" to enter the sterilization chamber 112, as shown in FIGURE 20B. Doors 131 and 132 are then closed. At this point, as shown in
- the first component pallet 70' is in the post-sterilization chamber 116, acting as a holding chamber, and the second component pallet 70" is in the sterilization chamber 112. Still referring to FIGURE 20C, doors 130 and 133 open to allow the movement of a third component pallet 70'" into the pre-sterilization chamber 114 and the first component pallet 70' out of the post-sterilization chamber 116. Doors 130 and 133 then close. The booth 110 would then contain second component pallet 70" in the sterilization chamber 112 and the third component pallet 70'" in the pre-sterilization chamber 114. The sequence is then repeated from the opening of doors 130 and 133 until all component pallets have passed through all three chambers of the booth 110.
- Movement of the pallets is controlled by the three independent conveyor surfaces 120, 122, and 124.
- the first conveyor surface 120 is responsible for receiving a pallet from the system and transporting the pallet into the pre-sterilization chamber 114.
- the first conveyor surface 120 and a second conveyor surface 122 work together to transport the pallet into the sterilization chamber 112.
- the second conveyor surface 122 and a third conveyor surface 124 cooperate to position the pallet within the post- sterilization chamber 116.
- the third conveyor surface 124 transports the pallet to the system for resumed handling.
- variations on the number of conveyor surfaces used may be made. Those skilled in the art would understand how to correlate the indexing of pallets to the movement of the conveyor surfaces should variations be necessary.
- the bag pallet 70a (FIGURE 21) or the vial/device pallet 70b (FIGURE 23) is positioned between the two electron beam sources 102.
- the shutters 136 are in a closed position.
- the shutters 136 are liquid cooled steel panels used to block the electron beam window before and after component sterilization and connection.
- the shutters 136 are attached to a pneumatic actuator 140 which is responsive to a controller (not shown).
- a single controller may be used to control the chamber doors, 130, 131, 132, and 133, the conveyor surfaces 120, 122, and 124, and the shutters 136, if desired.
- the appropriate controller can activate pneumatic actuator 140 to raise shutters 136 (FIGURE 22).
- the bag pallet 70a has additional heat shielding to protect the product of the components from electron beam exposure.
- a liquid-cooled, double-paneled heat shield 142 is initially positioned within the sterilization chamber 112. The lower portion 144 of the heat shield 142 is used to shield the bag component, and the upper portion 146 to shield the vial/device component 70b. As the bag holding portion of.
- the bag pallet 70a is raised by actuator 140 to raise the bag component in the connecting step of the sterilization process, the lower portion 144 of the heat shield 142 moves simultaneously to maintain the shielding of the bag component.
- the lower portion 144 Upon snap connection of the two components together, the lower portion 144 abuts the upper portion 146 of the heat shield 142.
- the heat shield 142 is retracted (i.e., the lower portion 144 is returned to its starting position) only after the shutters 136 are closed and then simultaneously with the return of the actuated bag holding portion of the bag pallet 70a.
- the pallet 70 is then transferred to the post-sterilization chamber 116 for holding, as described above. From the post-sterilization chamber 116, the pallet 70 is capable of travel to other stations for further processing.
- a pre-selected percentage of the sterilized pallets may be routed to a verification station (not shown).
- the dosimeter holder, 40a and 40b may be removed from the pallet, 70a and 70b, respectively.
- the holder may then be disassembled to gain access to the dosimeters 30.
- the dosimeters 30 should be handled with the necessary tools (e.g., tweezers) to prevent contamination.
- the absorbed radiation of each dosimeter 30 can be measured.
- the respective pallet may be validated as "sterile."
- the ability to validate the sterility of the components is a result of the correlated relationship determined to exist between the dosimeter film and the component on the pallet.
- the pallet may re-enter the assembly process.
- the dosimeter holder 40 can now be fitted with new dosimeters and reattached to a suitable pallet 70 to repeat the process.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2006547027A JP2007516774A (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for confirming a sterilization process |
AT04812618T ATE554794T1 (en) | 2003-12-23 | 2004-12-01 | METHOD AND DEVICE FOR VALIDATION OF STERILIZATION PROCESSES |
EP04812618A EP1708759B1 (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process |
PL04812618T PL1708759T3 (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process |
ES04812618T ES2386894T3 (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for the validation of sterilization processes |
CA2546846A CA2546846C (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process |
AU2004311924A AU2004311924B2 (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process |
MXPA06006475A MXPA06006475A (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process. |
AU2010219435A AU2010219435B2 (en) | 2003-12-23 | 2010-09-15 | Method and apparatus for validation of sterilization |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/745,466 | 2003-12-23 | ||
US10/745,466 US7641851B2 (en) | 2003-12-23 | 2003-12-23 | Method and apparatus for validation of sterilization process |
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PCT/US2004/040146 WO2005065728A1 (en) | 2003-12-23 | 2004-12-01 | Method and apparatus for validation of sterilization process |
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EP (2) | EP1708759B1 (en) |
JP (1) | JP2007516774A (en) |
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- 2004-12-01 WO PCT/US2004/040146 patent/WO2005065728A1/en active Application Filing
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EP2465544B1 (en) | 2014-03-19 |
AU2004311924A1 (en) | 2005-07-21 |
ATE554794T1 (en) | 2012-05-15 |
EP1708759A1 (en) | 2006-10-11 |
CN100556462C (en) | 2009-11-04 |
US20050135965A1 (en) | 2005-06-23 |
EP2465544A1 (en) | 2012-06-20 |
MXPA06006475A (en) | 2006-08-23 |
EP1708759B1 (en) | 2012-04-25 |
US8022375B2 (en) | 2011-09-20 |
CA2546846A1 (en) | 2005-07-21 |
ES2386894T3 (en) | 2012-09-05 |
AU2004311924B2 (en) | 2010-06-17 |
AU2010219435A1 (en) | 2010-10-07 |
US20100140515A1 (en) | 2010-06-10 |
CA2546846C (en) | 2012-08-28 |
ES2473315T3 (en) | 2014-07-04 |
CN1897982A (en) | 2007-01-17 |
PL1708759T3 (en) | 2012-09-28 |
AU2010219435B2 (en) | 2012-03-15 |
JP2007516774A (en) | 2007-06-28 |
US7641851B2 (en) | 2010-01-05 |
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