as) United States
`a2) Patent Application Publication (10) Pub. No.: US 2005/0173652 Al
`(43) Pub. Date: Aug. 11, 2005
`
`Ressler
`
`US 20050173652A1
`
`(54) SYSTEM AND METHOD FOR PRODUCT
`STERILIZATION USING UV LIGHT SOURCE
`
`Publication Classification
`
`(76)
`
`Inventor: Barry Ressler, Danbury, CT (US)
`
`(51) Unt, C07 cacccccsssssssesssnststnsssensnesee GOIN 23/00
`(52) US. Cd.
`caeescsssssssnssssnssetnststesnetesneee 250/455.11
`
`Correspondence Address:
`EPSTEIN DRANGEL BAZERMAN & JAMES,
`LLP
`60 EAST 42ND STREET
`SUITE 820
`
`NEW YORK, NY 10165 (US)
`
`(21) Appl. No.:
`
`11/056,698
`
`(22)
`
`Filed:
`
`Feb. 11, 2005
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/543,710,filed on Feb.
`1, 2004.
`
`(57)
`
`ABSTRACT
`
`System and method for sterilization, using UV light
`source(s), of products,
`e.g., polymer-based products,
`whether positioned within or external to their packaging,
`using monochromatic, continuous wave, high-intensity,
`incoherent light in single and/or multiple light source con-
`figurations. The treatment system(s) and method(s) may be
`used for sterilization of alternative products, including, for
`example, food products such as meat and poultry, enteral
`and/or parenteral solutions and systems, and the like.
`
`/00
`
`
`
`EXHIBIT 1016
`
`1
`
`EXHIBIT 1016
`
`

`

`Patent Application Publication Aug. 11,2005 Sheet 1 of 2
`
`US 2005/0173652 Al
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`FIGIA
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`2
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`US 2005/0173652 Al
`
`Aug. 11, 2005
`
`SYSTEM AND METHOD FOR PRODUCT
`STERILIZATION USING UV LIGHT SOURCE
`
`[0001] This application claims the benefit of U.S. Provi-
`sional Application No. 60/543,710 filed Feb. 11, 2004.
`
`BACKGROUND
`
`[0002]
`
`1. Technical Field
`
`[0003] The presentdisclosure is directed to system(s) and
`method(s) for sterilization of products and/or systems using
`UVlight source(s). More particularly, the present disclosure
`is directed to system(s) and method(s) for sterilization of
`polymer-based products, whether positioned within or exter-
`nal to their packaging, using monochromatic, continuous
`wave, high-intensity, incoherent light in single and/or mul-
`tiple light source configurations. The disclosed treatment
`system(s) and method(s) advantageously preserve physical
`and performance properties of the product/system while
`achieving a desired level of sterilization. The disclosed
`treatment system(s) and method(s) may be used for steril-
`ization of alternative products, including, for example, food
`products such as meat and poultry, enteral and/or parenteral
`solutions and systems, and the like.
`
`[0004]
`
`2. Background Art
`
`[0005] Sterilization is generally defined as the complete
`destruction of all organisms, including a large number of
`highly resistant bacterial endospores. A hostof sterilization
`techniques have been developed to address specific steril-
`ization needs. Typical sterilization techniques include the
`use of moist heat from a steam autoclave, ethylene oxide gas
`sterilizing techniques, dry heat
`techniques, and newer
`chemicalsterilizers.
`
`[0006] Steam sterilization is widely used and is generally
`viewed as relatively cost-effective sterilization technique.
`The use of steam sterilization techniques employing an
`autoclave is recognized as an efficient, simple, and relatively
`cost-effective approach for destroying all relevant organ-
`isms. However, certain components (e.g., medical device/
`instrumentation components and accessories) cannot endure
`the extremes of heat and pressure. For example, steam and
`pressure are known to damage rubber, Lexan® plastic
`components, and other synthetic materials, and the use of a
`steam autoclave for any anesthesia equipmentis generally
`not recommended, unless the treatment method is specifi-
`cally recommended by the manufacturer.
`
`[0007] Ethylene oxide is acceptable for many materials
`used in manufacturing medical devices and the like, includ-
`ing the reusable components of anesthesia machines, ven-
`tilators, and monitors. However,it is generally inappropriate
`to place these entire systems in an ethylene oxide chamber.
`In addition, polystyrene componentparts cannot be exposed
`to ethylene oxide gas. Ethylene oxide sterilization employs
`a powerful poisonous fumigant gas, and therefore mandates
`an appropriate means of aeration to remove all traces of
`residual gas. Workers exposed to ethylene oxide are required
`to comply with all procedures specified by OSHA and the
`EPA.Alternative chemical treatment techniques include the
`use of hydrogen peroxide and peroxyacetic acid with buffers
`and low heat.
`
`[0008] More recently, a sterilization technique was dis-
`closed in U.S. Pat. No. 5,786,598 to Clark et al., entitled
`
`“Sterilization of Packages and Their Contents Using High-
`Intensity, Short-Duration Pulses of Incoherent, Polychro-
`matic Light in a Broad Spectrum.” As notedin thetitle, the
`Clark *598 patent involves the use of high-intensity, short-
`duration pulses of incoherent, polychromaticlight in a broad
`spectrum to sterilize product containers and deactivate
`microorganismstherein. The Clark ’598 proposes “the deac-
`tivation of microorganisms within parenteral and/or enteral
`solutions and packages or within contact lens solutions and
`packages and/or ophthalmic solutions and packages.”[See
`col. 1, lines 11-20.] The use of short-duration pulses of
`incoherent, polychromatic light
`in a broad spectrum, as
`disclosed in the Clark °598 patent, is believed to be inef-
`fective and/or unacceptable for at least some aspects of the
`proposed applications.
`
`[0009] Despite efforts to date, a need remains for sys-
`tem(s) and/or method(s) for usein sterilizing polymer-based
`product(s), whether positioned within or external to their
`packaging, wherein such treatment
`regimen achieves a
`desired sterilization level without negatively affecting the
`physical properties and/or the efficacy of the underlying
`polymer-based product(s). A need also exists for system(s)
`and/or method(s) for use in sterilizing alternative products
`(e.g., food products such as meat and poultry, enteral and/or
`parenteral solutions and systems, and the like), whether
`positioned within or external to their packaging, wherein
`such treatment regimen achievesa desired sterilization level
`without negatively affecting the physical properties and/or
`the efficacy of the underlying product(s).
`
`[0010] These and other objectives are satisfied according
`to the present disclosure wherein sterilization is achieved
`using monochromatic, continuous wave, high-intensity,
`incoherent light in single and/or multiple light source con-
`figurations. The disclosed treatment system(s) and meth-
`od(s) advantageously achieve a desired sterilization level
`without negatively affecting the physical properties and/or
`the efficacy of the underlying product(s). These and other
`features/functionalities will be apparent to persons skilled in
`the art from the detailed description which follows>
`
`SUMMARYOF THE DISCLOSURE
`
`{0011] An advantageous approach for the sterilization of
`products, including heat sensitive materials, whether within
`or external to their packaging and/or packaging containers,
`is disclosed herein. The disclosedsterilization system(s) and
`method(s) are effective in inactivating viral and bacterial
`microorganisms without physical or performance damage to
`the treated product or its packaging. A single or multiple
`array of light sources delivers monochromatic germicidal,
`ambient temperature light at radiance levels of at least 200
`mw/cm? to 600 mw/cm? to deactivate multiple organisms.
`According to exemplary embodiments of the present disclo-
`sure, products are sterilized to Sterilization Assurance Lev-
`els (SALs) ofat least 10-> cfu/mlat discrete wavelengths of
`193; 222; 248; 282; 308 and 354 nm (4/-5 nm).
`
`[0012] The disclosedsterilization treatment regimen may
`be undertaken in a batch, semi-batch or continuous mode. In
`an exemplary embodimentof the present disclosure, target
`product(s) and/or container-packaged product(s) are treated
`continuously by positioning the product(s)/container(s) on a
`moving element(e.g., a belt) that is moved above, below or
`between one or more light sources. The rate at which the
`
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`Aug. 11, 2005
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`product(s)/container(s) are moved past the light source(s)
`may be adjusted so as to achieve the desired energytreat-
`mentlevel. In batch/semi-batch embodiments, the treatment
`time may bevaried to achieve the desired energy treatment
`level. As noted below, additional processing parameters
`affect
`the sterilization procedure, and may be adjusted/
`selected (either alone or in combination with the rate/
`residence time) to achieve the desired sterilization result(s).
`[0013] Thus,
`the intensity of the monochromatic light
`source(s) that are employed according to the sterilization
`system(s) and/or method(s) of the present disclosure may be
`adjusted to achieve the desired sterilization results. For
`example,
`in processing systems wherein multiple light
`sources are employed, the individual light sources may be
`operated at different intensities to achieve the desired ster-
`ilization results. Light source intensity is generally selected
`based on the treatment algorithm for a single microorganism
`or suite (panel) of organisms/microorganisms. In typical
`treatment regimens, the panel of organisms includes, but is
`not limited to, Bacillus pumilus (spore former), Candida
`albican (yeast), lipid and non-lipid virus, Clostridium sporo-
`genes (anaerobic spore former), Staphylococcus aureus
`(vegetative Gram positive), Pseudomonas aeruginosa (veg-
`etative Gram negative), Aspergillus niger
`(filamentous
`fungi), Mycobacterium terrae, Porcine Parvo Virus (PPV
`and B19), Lysteria, and Salmonela. Thesterilization treat-
`ment regimen disclosed herein is effective in treating prod-
`ucts/packaging of varying geometries. Thus, for example,
`the product and/or product package may be planar, convex,
`concave or an alternative geometry, e.g., a geometric com-
`bination of the foregoing geometries. The light sources may
`be modified to achieve desired results. Thus, for example,
`partially coated optical surfaces may be employed, such
`coated surfaces being advantageously tuned to a desired
`monochromatic wavelength. The use of partially coated
`optical surfaces may beeffective in generating light that
`satisfies spectral intensity requirements in excess of 500
`mw/cm .
`
`[0014] Additional features and functionalities associated
`with the disclosedsterilization system(s) and method(s) will
`be apparent from the detailed description which follows,
`particularly when viewed together with the figures appended
`hereto.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`[0015] To assist those of ordinary skill in the art to which
`the present disclosure appertains in making and using the
`disclosed sterilization system(s) and method(s), referenceis
`made to the appendedfigures, wherein:
`[0016]
`FIG.1 is a photograph (top view) of an exemplary
`sterilization system/assembly for delivering monochro-
`matic, continuous wave, high-intensity, incoherent light to
`products, e.g., polymer-based products, using a single light
`source according to the present disclosure;
`[0017]
`FIG.1A is a photograph (side view) of the exem-
`plary sterilization system/assembly of FIG.1, with the cover
`structure positioned in a closed position; and
`[0018]
`FIG.2 is a photograph(side view)of an alternative
`exemplary sterilization system/assembly for delivering
`monochromatic, continuous wave, high-intensity, incoher-
`ent light to products, e.g., polymer-based products, using
`dual light sources (top and bottom) according to the present
`disclosure.
`
`DETAILED DESCRIPTION OF EXEMPLARY
`EMBODIMENT(S)
`
`[0019] According to the present disclosure, systems and
`methodsfor sterilization of products, including heat sensi-
`tive materials, whether within or external to their packaging
`and/or packaging containers, are provided. These systems/
`methods are effective in inactivating viral and bacterial
`microorganisms without physical or performance damage to
`the treated product or its packaging. A single or multiple
`array of light sources delivers monochromatic germicidal,
`ambient temperature light at irradiance levels of at least 200
`mw/cm” to 600 mw/cm* to deactivate multiple organisms.
`According to exemplary embodiments of the present disclo-
`sure, products (e.g., packaged contact lenses) are sterilized
`to Sterilization Assurance Levels (SALs) of at least 107°
`cfu/ml (colony forming units/milliliter) at discrete wave-
`lengths of 193; 222; 248; 282; 308 and 354 nm (4/-5 nm).
`Currently preferred wavelengths for use in sterilizing treat-
`ments of polymeric contact lens products (whether packaged
`or non-packaged) are 282 and 308 nm.
`
`[0020] The disclosedsterilization treatment regimen may
`be undertaken in a batch, semi-batch or continuous mode.
`The application of monochromatic UV light using the dis-
`closed light source(s) to inactivate viral and bacterial micro-
`organisms in sterilizing contact
`lenses is a particularly
`attractive alternative to currently practiced sterilization
`methods, such as steam sterilization, because the disclosed
`UVradiation treatmentis readily incorporated into an in-line
`(i.e., continuous or substantially continuous) process,
`in
`which the sterilization may be accomplished in a matter of
`secondsorless. In addition,. the disclosed monochromatic
`UV light
`is effective for sterilization of heat sensitive
`materials without negatively affecting physical properties
`and/or performance attributes thereof. Additional perfor-
`mance features/functionalities associated with such poly-
`mer-based products (e.g., contact
`lenses) that were not
`feasible with conventional steam sterilization (e.g., because
`steam sterilization damaged or destroyed such features/
`functionalities) are potentially feasible using the disclosed
`monochromatic UVsterilization technique.
`
`In an exemplary embodiment of the present dis-
`[0021]
`closure, target product(s) and/or container-packaged prod-
`uct(s) are treated continuously by positioning the product(s)/
`container(s) on a moving element(e.g., a belt) that is moved
`above, below or between one or more light sources. For
`example, with reference to FIG. 2, top and bottom light
`sources define an intermediate region in which products
`(e.g., packaged contact lenses) may be transported for ster-
`ilization treatment. A variety of structures and mechanisms
`may be used to transport products through the intermediate
`region while permitting UV radiation to reach the products
`for sterilization purposes, e.g., conveyor belts and/or tracks
`of various designs and constructions. The selection and
`implementation of appropriate conveyor/transport systems
`is well within the skill of persons skilled in the art. It is
`further expressly noted that transport systems may be incor-
`porated in single light source implementations of the dis-
`closed sterilization systems, e.g., of the type depicted in
`FIG. 1 hereto.
`
`[0022] The rate at which the product(s)/container(s) are
`moved past
`the light source(s) in continuous or semi-
`continuous embodiments of the present disclosure may be
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`
`adjusted so as to achieve the desired energy treatmentlevel.
`Similarly, in batch/semi-batch embodiments, the treatment
`time may bevaried to achieve the desired energy treatment
`level. As noted below, additional processing parameters
`affect
`the sterilization procedure, and may be adjusted/
`selected (either alone or in combination with the rate/
`residence time and/or other processing parameters)
`to
`achieve the desired energy delivery and resultant steriliza-
`tion effect(s).
`
`the intensity of the monochromatic light
`[0023] Thus,
`source(s) that are employed according to the sterilization
`system(s) and/or method(s) of the present disclosure may be
`adjusted to achieve the desired sterilization results. For
`example,
`in processing systems wherein multiple light
`sources are employed, the individual light sources may be
`operated at different intensities and/or for different periods
`of time to achieve the desired sterilization results. A control
`system may be advantageously associated with the light
`source(s) to control operating parameters thereof. A typical
`control system includes a processor that is programmed to
`operate the light sources at desired intensity levels and for
`desired period(s) of time. In the case of continuoustreatment
`regimens, the control system may also advantageously con-
`trol the rate at which products pass through the treatment
`region, e.g., based on the speed of the conveyor/transport
`system. A manual over-ride is typically provided, so as to
`permit an operator to adjust/modify treatment parameters on
`an as-needed basis.
`
`[0024] Treatment parameters, e.g., light source intensity,
`are generally selected based on the treatment algorithm for
`a single microorganism or suite (panel) of organisms/micro-
`organisms.In typical treatment regimens,the panel of organ-
`isms includes,but is not limited to, Bacillus pumilus (spore
`former), Candida albican (yeast), lipid and non-lipid virus,
`Clostridium sporogenes (anaerobic spore former), Staphy-
`lococcus aureus (vegetative Gram positive), Pseudomonas
`aeruginosa (vegetative Gram negative), Aspergillus niger
`(filamentous fungi), Mycobacterium terrae, Porcine Parvo
`Virus (PPV and B19), Lysteria, and Salmonela. Additional
`and/or alternative organisms may beutilized, in whole or in
`part, in developing and implementing an appropriate treat-
`ment regimen, as will be readily apparent to persons skilled
`in the art. Sterilization treatment regimensutilizing mono-
`chromatic germicidal, ambient temperature light, as dis-
`closed herein, are effective in treating products/packaging of
`varying geometries. Thus, for example, the product and/or
`product package may be planar, convex, concave or an
`alternative geometry, e.g., a geometric combination of the
`foregoing geometries. The light sources may be modified to
`achieve desired sterilization results. Thus,
`for example,
`partially coated optical surfaces may be employed, such
`coated surfaces being advantageously tuned to a desired
`monochromatic wavelength. The use of partially coated
`optical surfaces may beeffective in generating light that
`satisfies spectral intensity requirements in excess of 500
`mw/cm .
`
`[0025] Light source systems according to the present
`disclosure emit light over a large active area and are advan-
`tageously configured to operate at ambient temperatures.
`The substantially monochromatic output of these sources
`can be tuned to produce high spectral irradiance (watts/nm)
`within peaks of the process action spectra to maximize the
`germicidal effectiveness (or other desired process/applica-
`
`tion) as a function of the required biological objective. The
`range of available geometries (including coaxial sources
`radiating either inwardly or outwardly, and planar sources
`emitting from one or both sides) and the capability to
`independently adjust
`irradiance and total power provide
`significant flexibility in system design and allow for more
`efficient light delivery systems.
`
`[0026] With particular reference to FIGS. 1 and 1A,
`exemplary treatment system 100 includes a base structure
`102 and a cover structure 104. Cover structure 104 is
`
`hingedly mounted with respect to base structure 102 and
`includes a handle 106 to facilitate repositioning thereof (i.e.,
`opening/closing). FIG. 1 shows cover structure 104 in an
`“open” position, and FIG. 1A showscoverstructure 104 in
`a “closed” position. Cover structure 104 is typically fabri-
`cated from a material that is effective in filtering/shielding
`the light rays produced by the light source so as to protect
`operators and others in the vicinity of treatment system 100.
`Thus,
`the size and geometry of cover structure 104 is
`typically selected so as to permit positioning of product(s) in
`an appropriate treatmentposition relative to the light source,
`while ensuring that
`the emitted light rays are filtered/
`shielded thereby.
`
`[0027] Treatment system 100 includes a light source 108
`positioned within base structure 102 that
`is designed to
`generate and emit monochromatic germicidal, ambient tem-
`perature light through treatment windows 110a, 110b. Light
`source 108 is an excimer light source that generally pro-
`duces 90% of its output within a 10 nm band that can be
`discretely adjusted across the VUV, UV-A, UV-B and UV-C
`by changing the rare and/or halogen gases used. Efficiencies
`vary with gas mix and geometry from 10% to >30% with
`demonstrated input powers from <1 watt to >10 kW. The
`overall design and operation of exemplary light sources for
`use in the disclosed system are disclosed, described and
`depicted in commonly assigned patent applications, Ser. No.
`09/805,610 (filed Mar. 13, 2001; published as U.S. Pat. Ser.
`No. 2002-0177118 A1) and Ser. No. 10/661,262 (filed Sep.
`12, 2003) (the “Prior Applications”), the entire contents of
`which are hereby incorporated by reference in their entire-
`ties. For example,
`the Prior Applications disclose and
`describe exemplary flow patterns/arrangements for the intro-
`duction and withdrawal of cooling fluids (e.g., see tubing/
`hoses in FIGS. 1 and 1A), exemplary treatment window
`designs and the like, each of which is visually apparent in
`FIG. 1 and/or FIG. 1A.
`
`[0028] According to exemplary embodiments of the dis-
`closed systems, an appropriate fluid is used to maintain the
`light source(s) at a desired temperature and/or within a
`desired temperature range. Water
`is
`a preferred heat
`exchange medium for dissipating/absorbing heat generated
`through operation of the light source(s). However, alterna-
`tive cooling fluids may be employed, as will be apparent to
`personsskilled in theart. In selecting an appropriate cooling
`fluid, it is desirable to select a fluid that, in use, is substan-
`tially transparent to the germicidal radiation to be passed
`therethrough. Ofnote, it is also desirable to select a fluid that
`is not susceptible to bubble generation and/or bubble propa-
`gation, because the presence/formation of bubbles can unde-
`sirably scatter germicidal radiation and negatively effect the
`sterilization efficiency and/or effectiveness of the disclosed
`system. Thus, precautions may be advantageously taken to
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`minimize and/or prevent bubble formation/propagation in
`cooling fluid use, e.g., through the use of appropriate addi-
`tives or the like.
`
`[0029] Thus, in use, productsforsterilization, e.g., contact
`lens products, medical products and/or components, food
`products and the like (whether packaged or non-packaged)
`are positioned above a window 110a, 110b,
`the cover
`structure 106 is “closed” soas to shield the treatment region,
`and the light source 108 is energized to deliver monochro-
`matic germicidal, ambient temperature light thereto. The
`light source is advantageously maintained at a substantially
`controlled temperature through heat transfer/heat exchange
`modalities, as described in the Prior Applications. As noted
`above,
`the Prior Applications are incorporated herein by
`reference in their entireties.
`
`[0030] With reference to FIG. 2, a further exemplary
`treatment system 200 is depicted. System 200 includesa first
`(upper) light source housing 202 and a second (lower) light
`source housing 204. Light sources (not visible) are posi-
`tioned within housings 202, 204 and are advantageously
`maintained at a substantially constant temperature utilizing
`heat transfer/heat exchange modalities, as described in the
`Prior Applications. A treatment
`region 206 is defined
`between housings 202, 204. Treatment windows (not vis-
`ible) are defined in the first and second housings 202, 204,
`such that monochromatic germicidal light from the respec-
`tive light sources may reach products within treatment
`region 206.
`
`[0031] Aconveyor/transport system (not visible) is advan-
`tageously provided for transporting products throughtreat-
`mentregion 206,i.c., between housings 202, 204. According
`to exemplary embodiments of the present disclosure,
`the
`conveyor may advance the products through treatment
`region 206 in a fixed orientation relative to the light
`source(s). Alternatively,
`in may be desirable to include
`structure(s) and/or mechanism(s) that are effective to cause
`repositioning of the productsrelative to the light source(s) as
`they pass through the treatment region. For example, in the
`case of thick and/or irregularly shaped products, it may be
`desirable to effect rotation of the products at one or more
`points within the treatment region. Effective structure(s)
`and/or mechanism(s)for effecting reorientation of the prod-
`ucts within the treatment region may be associated with the
`conveyor, with the upper and/or lower housings, or a com-
`bination thereof. The repositioning of the products may be
`effected in a substantially random fashion,e.g., by providing
`diverter walls or the like, or may be effected in a controlled
`fashion, e.g., through controlled roboticsor the like. In any
`case, the inclusion of a repositioning mechanism may be
`desirable to provide efficient and reliable sterilization treat-
`ments to products of various sizes and geometries.
`
`[0032] The distance between upper housing 202 and lower
`housing 204 is generally selected to permit passage of
`desired products therebetween with minimal clearance.
`According to exemplary embodiments of the present disclo-
`sure,
`the spacing between housings 202, 204 may be
`adjusted, e.g., by repositioning at least one of housings 202,
`204 relative to the other housing. Thus, for example, upper
`housing 204 may be supported by a frame structure that
`permits/facilitates vertical repositioning thereof relative to
`lower housing 202 (e.g., through manual or powered repo-
`sitioning of upper housing 204). As noted previously, the
`
`light source within upper housing 204 may be designed/
`configured to deliver monochromatic light having different
`characteristics relative to the light source within lower
`housing 202. Thus, the dual light source arrangement of
`FIG. 2 further enhances the flexibility/versatility of the
`disclosed sterilization regimens according to the present
`disclosure.
`
`[0033] According to the present disclosure, a sterilization
`assurance level (SAL) of 10-° may be achieved for inocu-
`lated product and packaging that include a panel that may
`include (but are not
`limited to) Bacillus pumilus (spore
`former), Candida albican (yeast), Lipid and non-lipid virus,
`Clostridium sporogenes (anaerobic spore former), Staphy-
`lococcus aureus (vegetative Gram positive), Pseudomonas
`aeruginosa (vegetative Gram negative), Aspergillus niger
`(filamentous fungi), Mycobacterium terrae, Porcine Parvo
`Virus (PPV and B19), Lysteria, Salmonela. In achieving the
`foregoing SAL, the overall performance properties of the
`sterilized products (whether packaged or non-packaged),
`e.g., contact lenses or the like, are not materially affected.
`
`In operating the disclosed sterilization treatment
`[0034]
`systems, numerous processing variables and/or product
`properties may influence the effectivenessofthesterilization
`treatment and/or the associated product survivability criteria
`(e., post-sterilization product performance and/orefficacy).
`For example, exemplary processing variables and product
`properties that may require consideration in developing
`appropriate/optimal processing parameters
`for
`contact
`lenses include:
`
`[0035] Power delivery to light sources (Power is
`directly related to the UV radiation dose delivered to
`products)
`
`time is directly
`time (Treatment
`[0036] Treatment
`related to the UV radiation dose delivered to prod-
`ucts)
`
`[0037] Base Curve of contact lenses to be treated
`(Base curve radius mayinfluencethe desired/optimal
`UVradiation dose)
`
`lenses to be treated
`[0038] Diameter of contact
`(Diameter may influence the desired/optimal UV
`radiation dose)
`
`[0039] Oxygen Permeability of contact lenses (Oxy-
`gen permeability may influence the desired/optimal
`UVradiation dose)
`
`[0040] Equilibrium Water Content of contact lenses
`(Equilibrium water content may influence
`the
`desired/optimal UV radiation dose)
`
`lenses (Modulus may
`[0041] Modulus of contact
`influence the desired/optimal UV radiation dose)
`
`[0042] Elongation at break of contact lenses (Elon-
`gation at break may influence the desired/optimal
`UVradiation dose)
`
`lenses (Tensile
`[0043] Tensile Strength of contact
`strength may influence the desired/optimal UV
`radiation dose)
`
`[0044] Toughness modulus of contact lenses (Tough-
`ness modulus may influence the desired/optimal UV
`radiation dose)
`
`7
`
`

`

`US 2005/0173652 Al
`
`Aug. 11, 2005
`
`[0045] Although the present disclosure has been described
`with reference to exemplary embodimentsthereof,it is to be
`understoodthat the disclosure is not limited thereto. Rather,
`the systems and methods disclosed herein encompass modi-
`fications, enhancements and/or variationsthat will be readily
`apparent to persons skilled in the art, based on a review of
`the present disclosure, including specifically the Prior Appli-
`cations incorporated herein by reference in their entireties.
`
`1. Anon-laser light source for sterilization of products of
`the type disclosed herein, the light source comprising: a) a
`housing defined byat least one outer wall; and b) a bounded
`
`volumeof photon-producing gas mounted within said hous-
`ing; wherein at least a portion of said outer wall is substan-
`tially transparent
`to photons produced by said bounded
`volume of gas.
`2. A method of applying monochromatic light (e.g., of
`wavelengths 193, 222, 248, 282, 308 and 354 nm) in a
`sterilization dosage to substrates,
`including ophthalmic
`devices and other products of the type disclosed herein
`(whether packaged or non-packaged).
`
`8
`
`