Methods and Apparatus for Preparing Autologous Blood Eye Drops

Abstract

Methods and apparatus for preparing autologous blood serum eye drops within a potentially contaminating environment are disclosed. Key convenience kit apparatus providing novel methodology includes a plastic bag in which an innovative tray securely holds a plurality of empty eye drop bottles and associated caps disposed and sealed therein. Providing the only access pathway into the bag is a sterilizing filter appliance which filters all fluid entering the bag and provides a nozzle for dispensing into bottles disposed in the tray. The key convenience kit apparatus is sterilized prior to use, assuring all components disposed within the bag are within a desired sterility assurance level. The sterilized state of items associated with the key apparatus is maintained by the single pathway for fluid. Capping and sealing the bottles before opening the bag permits delivery of sterile product for use outside the bag.

Claims

1. (canceled)

2. A method for making and using a portable convenience kit for producing autologous blood serum eye drops, sterilized to a predetermined sterility assurance level, dispensed into bottles and sealed closed for delivery into a potentially contaminating environment without using special equipment, such as a controlled, sterilized state workplace in which fluids can be distributed and maintained free from contamination, such as a laminar flow hood, comprising the follow steps: i. providing the convenience kit comprising: a. a plastic bag, comprising an accessible opening for displacement of items therein, being constructed of material which is sufficiently supple and impenetrable to permit digital manipulation from outside the bag of items disposed therein without severing, being constructed with sufficient material disposed about the opening to permit sealing the bag closed and comprising an exterior surface which completely envelopes and protects sterility of articles disposed therein; b. a filter appliance comprising a gasket and a first filter component, each of which comprises two opposing fluid conducting conduits and a sterilizing grade filter disposed to filter all fluid which is displaced between the conduits, one of said conduits being displaced through a hole in said bag which is sealed closed about the inserted conduit by said gasket; c. a combination comprising at least one eye drop bottle and at least one associated cap which when securely affixed to said bottle closes an orifice through which liquid is dispensed and thereby provides secure sterility protection for bottle contents; d. a tray, which provides a plurality of stabilizing support cavities, comprising one cavity for each bottle and for each cap of said combination, each said bottle cavity being sized and shaped to secure an inserted bottle from displacement due to tray transport and rotation when a cap is applied thereto and each said cap cavity being sized and shaped for securing a cap in transport and being disposed for facile digital access from outside said bag; ii. disposing the number of bottles to be filled and associated caps in said tray; iii. affixing said filter appliance to said bag to provide the only fluid pathway into said bag after the accessible opening is sealed; iv. sealing said opening; v. sterilizing said convenience kit to a predetermined sterility assurance level; vi. providing implements for acquiring blood from a donor patient, separating and accessing serum from acquired blood; vii. establishing a ratio of serum volume to saline volume for a prescribed dose; viii. measuring quantity of acquired blood and determining there from the volume of saline to be mixed with the acquired serum to produce the prescribed dose; ix. preparing a measured quantity of saline; x. dispensing and thereby displacing desired sterilized quantities of saline and serum through and from said filter appliance into the bottles; xi, digitally displacing and securely affixing a sealing cap to each bottle; and xii. after all bottles are filled and capped, breaching the bag and extracting bottles containing protected sterile product for use.

3. Further steps in method for making the convenience kit according to claim 1 comprising: A method for making a portable aseptic level assurance convenience kit for producing autologous blood serum eye drops, sterilized to a predetermined sterility assurance level, dispensed into bottles and sealed closed for delivery into a potentially contaminating environment without using special equipment which provides a controlled, sterilized state workplace in which fluids can be distributed and maintained free from contamination, such as a laminar flow hood, comprising the follow steps: i. providing the convenience kit comprising: a. a plastic bag, comprising an accessible opening for displacement of items therein, being constructed of material which is sufficiently supple and impenetrable to permit digital manipulation from outside the bag of items disposed therein without severing, being constructed with sufficient material disposed about the opening to permit sealing the bag closed and comprising an exterior surface which completely envelopes and protects sterility of articles disposed therein; b. a filter appliance comprising a gasket and a first filter component, each of which comprises two opposing fluid conducting conduits and a sterilizing grade filter disposed to filter all fluid which is displaced between the conduits, one of said conduits being displaced through a hole in said bag which is sealed closed about the inserted conduit by said gasket; c. a combination comprising at least one eye drop bottle and at least one associated cap which when securely affixed to said bottle closes an orifice through which liquid is dispensed and thereby provides secure sterility protection for bottle contents; d. a tray, which provides a plurality of stabilizing support cavities, comprising one cavity for each bottle and for each cap of said combination, each said bottle cavity being sized and shaped to secure an inserted bottle from displacement due to tray transport and rotation when a cap is applied thereto and each said cap cavity being sized and shaped for securing a cap in transport and being disposed for facile digital access from outside said bag; ii. disposing the number of bottles to be filled and associated caps in said tray; iii. affixing said filter appliance to said bag to provide the only fluid pathway into said bag after the accessible opening is sealed; iv. sealing said opening; v. sterilizing said convenience kit to a predetermined sterility assurance level; vi. providing a second filter component which comprises fittings for securely but releasibly affixing said second filter to said first filter to cascade flow through both filters whereby, when said second filter is so affixed, values of concentration of filterable particulates, nature of particulates to clog a filter and volume of dispensed liquid do not diminish effective duration of kit effectiveness.

4. Portable convenience kit apparatus for preparing autologous blood serum eye drops, sterilized to a predetermined SAL, within a potentially contaminating environment away from special equipment which provides a controlled, sterilized workplace in which fluids are distributed and maintained free from contamination, such as a laminar flow hood, comprising the following: a plastic bag comprising an initially exposed opening through which bagged kit contents can be displaced into the bag and an otherwise closed and shrouding surface, said surface comprising sufficient continuity and thickness to obstruct fluid displacement there through, volume capacity to permit the liquid to be displaced into the at least one eye drop bottle and flexibility and suppleness for digital manipulation; a tray comprising a cavity for each at least one eye drop bottle and one cavity for each associated eye drop vessel cap, said eye drop vessel cavity comprising shape and dimensions by which a bottle is securely held from displacement during transport and capping and said cap cavity comprising shape and dimensions by which a cap is securely held during transport, but forcibly releasable by digital manipulation. the at least on bottle comprising an open orifice into which liquid is dispensed and a cap interface which assures a sterility maintaining enclosures when a cap is affixed thereto; the cap associated with the at least one bottle comprising a compatible interface for the at least one bottle and an exterior surface modified by material that increases friction between cap and bag to permit digital manipulation of said cap; and a filter appliance comprising a first filter component comprising a pair of opposing extended length communicating conduits providing a fluid passageway for liquid dispensing, one of said conduits securely and permanently affixed to said bag to provide the only passageway into the bag when sealed.

5. A portable convenience kit apparatus for preparing autologous blood serum eye drops according to claim 4 wherein said filter appliance comprises a second filter component disposed upstream from said first filter component and so aligned with the first filter component that liquid flow is cascaded through both filters such that the second filter component traps and holds material so filtered and securely, but releasibly interconnected to said first filter for removal and replacement such that values of concentration of filterable particulates, nature of particulates to clog a filter and volume of dispensed liquid do not diminish effective duration of kit effectiveness.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] FIG. 1 is a perspective of an exemplary tray made according to the instant invention with cavities of predetermined shape and size filled with caps and bottles which are examples of items employed for filling and capping eye drops to preserve sterility thereof.

[0061] FIG. 1A is a perspective of a perspective of an assembled key kit made according to the instant invention, the kit comprising a first filter appliance, a portion of which is seen disposed outside a plastic bag, items enclosed within the bag being the tray seen in FIG. 1 securely holding a plurality of bottles and bottle caps.

[0062] FIG. 1B is a perspective of another embodiment of an assembled key kit which is the same as the key kit seen in FIG. 1B except that a second filter appliance is affixed to the first filter appliance such that filtering by the two filter appliance is cascaded.

[0063] FIG. 2 is a perspective of the plastic bag and filter appliance parts, seen in FIG. 1B, but before assembly, the bag having an open end and a filter component seen to be disposed outside the bag and associated filter appliance and bag sealing components with an assembly tool disposed within confines of the bag.

[0064] FIG. 2A is a perspective of a section of tubing for use as a sealing interface gasket having predetermined length and internal diameter relative to the filter component seen in FIG. 2

[0065] FIG. 2B is a perspective of a segment of the bag seen in FIG. 2 with a portion of a filter component having pierced the bag and disposed snugly within a hole formed therein.

[0066] FIG. 3 is a perspective of a segment of the bag seen in FIG. 2, similar to the segment seen in FIG. 2B, with a portion of a filter component disposed outside the bag and another portion disposed through an unseen orifice disposed in the bag (but unseen) with components affixed to the inside portion to seal about the orifice.

[0067] FIG. 4 is a perspective of a bottle to be disposed within the tray seen as in FIGS. 1 and 1A.

[0068] FIG. 5 is a perspective of a cap for closing and providing a seal to protect contents of the bottle seen in FIG. 4.

[0069] FIG. 6 is a perspective of the tray seen in FIG. 1 with a plurality of empty cavities.

[0070] FIG. 7 is a perspective of a bag comprising an affixed filter appliance as seen in part in FIG. 1A and a tray filled with bottles and caps and disposed within the bag, with the open end seen in FIG. 2, closed and sealed.

[0071] FIG. 8 is a perspective of a plurality of evacuated tube blood draw vessels (e.g. Becton Dickinson Vacutainers).

[0072] FIG. 9 is an exploded perspective of an evacuated tube blood draw vessel seen in FIG. 8 and a tube access barrel used to mete out blood or blood constituents from the vessel.

[0073] FIG. 10 is a perspective of separate items used in a larger kit to support the key kit.

[0074] FIG. 10A is a perspective of a combination of a medical syringe seen in FIG. 10 affixed to an evacuated tube access barrel wherein a blood draw tube is inserted for selectively accessing blood constituents.

[0075] FIG. 11 is a cross section of the conventional medical syringe seen in FIG. 10A, comprising a measurable volume of liquid accessed from one or more blood draw vessels.

[0076] FIG. 12 is an exemplary dosing chart comprising indicia from which a desired volume of saline can be derived for mixing with predetermined volume of serum for producing a dose of eye drops.

[0077] FIG. 13 is a perspective of a conventional syringe affixed to a female/female fitting (as seen in FIG. 10) and thereby affixed to a pre-filled syringe for acquiring saline.

[0078] FIG. 13A is a cross section of the medical syringe seen in FIG. 13 with a predetermined volume of saline disposed therein.

[0079] FIG. 14 is a perspective of the syringes seen in FIGS. 11 and 13 affixed together via the female/female adapter.

[0080] FIG. 14A is a cross section of the syringes seen in FIGS. 11, 13 and 14 with all liquid dispensed into a single syringe and a double arrow disposed to indicate relative displacement of syringe pistons for mixing.

[0081] FIG. 15 is a perspective of the assembled key kit, seen in FIG. 1, with the filter appliance upwardly disposed to center the tray disposed therein and to tent the bag thereby disposing the filter appliance for dispensing liquid into the bottles.

[0082] FIG. 15A is a perspective of upwardly displacing and tenting the bag similar to the method seen in FIG. 1, but employing an additional hand to aid in centering the associated tray.

[0083] FIG. 16 is a perspective of the assembled key kit, seen in FIGS. 15 and 16, with the syringe seen in FIGS. 10 and 11 containing a serum/saline mixture and affixed to the filter component of the filter appliance for dispensing liquid into bottles thereby.

[0084] FIG. 17 is a perspective wherein a bottle cap is digitally accessed for removal from the tray for being affixed to a bottle (into which a predetermined volume of serum/saline mixture has been dispensed).

[0085] FIG. 17A is a perspective wherein the bottle cap digitally accessed in FIG. 17 is being digitally affixed to a bottle.

[0086] FIG. 18 is a perspective of bottles securely capped for protecting sterility of mixture disposed therein, thus permitting safety in displacing the bottles from the plastic bag.

[0087] FIG. 19 is a perspective of an insulated pouch for storing and transporting capped bottles after displacement from the plastic bag and then the tray and plastic bag as seen in FIG. 18.

[0088] FIG. 20 is a perspective of a freezer pack used to maintain a desired temperature inside the pouch seen in FIG. 19.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0089] Reference is now made to the embodiments illustrated in FIGS. 1-20 wherein like numerals are used to designate like parts throughout. For parts which are similar but not the same in form and function as parts originally specified with a given number, a prime of the original numbers is used.

[0090] This inventive method is specifically dedicated to preparing autologous blood serum eye drops. While inventive properties disclosed may be applied throughout a wide variety of applications, the following description is singly focused on eye drop production.

Kit Preparation Steps

[0091] In FIG. 1, a tray 2 is seen wherein a plurality of eye drop bottles, each generally numbered 4, are disposed within cavities, generally numbered 5, and associated bottle caps, generally numbered 6, are disposed in cavities, generally numbered 7. Tray 2 is a key element of the instant invention providing a stabilizing base for transport and securing bottles 4 and caps 6 as disclosed in detail hereafter.

[0092] Reference is now made to FIG. 1A wherein an assembled convenience kit 10 made according to the instant invention is seen. A preferred clear plastic bag 20 is seen to completely envelope a plurality of bottles 4 and associated caps 5 disposed and restrained in a tray 2. To be ready for use, kit 10 has been sterilized to a predetermined SAL. A filter appliance 50 has been disposed through a singular hole in bag 20 (not seen in FIG. 1A). Filter appliance 50 comprises a filter component 60 and the only fluid access path 70 into bag 20. Filter component 60 is preferred to be a 0.2 micron sterilizing filter which assures that all fluid displaced along path 70 is sterilized to a predetermined SAL, thereby assuring everything within bag 20 remains sterile in any environment until bag 20 is opened. Filter components, such as filter component 60 are widely used and commercially available for sterilizing fluids in contemporary medical practice.

[0093] However, filtering of biological materials, such as serum, yields a wide variety of particles and other separated products which must be retained within the filter component to produce a filtered product sterilized to the predetermined SAL. The unpredictable nature and bulk can clog to produce sufficient obstruction to flow that an undesirable pressure is required to continue dispensing through filter component 60. Such obstruction of filter component 60 is catastrophic to device such as kit 10, which depends upon continued flow for proper performance. For this reason, a second filter component 60 is securely, but releasibly affixed to filter component 60 to cascade flow through both filters, as seen in FIG. 2. As such filter component 60 becomes a collector of filtered debris with only filtered liquid being displaced through filter component 60. Thus, when filter component 60 is obstructed, removal or removal, with replacement, of filter component 60 permits continued use of kit 10 in production of eye drops.

[0094] Reference is made to FIG. 2 wherein a sequence for assembling filter appliance 50 to bag 20 is seen. Therein, filter component 60 is seen to comprise a female luer fitting 80, an increased radius housing 82, which contains the 0.2 micron filter (not shown), and a male luer fitting 84.

[0095] As seen in FIG. 2B, male luer fitting 84 comprises a distal end 84 which is diminished sufficiently in size to permit fitting 84 to pierce bag 20 forming a hole 85, therein, about fitting 84. Material characteristics of plastic bag cause hole edges to reluctantly give way, resulting in hole 85 circumference 85 snugly fitting about fitting 84 with no laterally extending tear.

[0096] Also as seen in FIG. 2B, disposed directly below fitting 84 is a section 86 of tubing sized and shaped to provide a gasket about the hole through which fitting 84 is disposed and about fitting 84. Cylindrical shape of tubing section 86 is seen in FIG. 2A. A female luer fitting 88, as shown in FIG. 3, is disposed directly below tubing section 86. Female luer fitting 88 is disposed to force an integrally molded, superiorly disposed shoulder ring 89 (see FIG. 2) compressively against tubing section 86 (as seen in FIG. 2B) such that tubing section 86 acts as a gasket against the hole in plastic bag 20 which is to be formed by piercing bag 20 and disposed to surround fitting 84. Preferably, fitting 88 is adhesively affixed to fitting 84. An assembly tool 90 (see in FIG. 2) comprising a patterned hole 92 for stabilizing fitting 88 is preferably used when fitting 84 as displaced into fitting 88 for attachment. A fully assembled filter appliance 50 is seen in FIG. 3 disposed through a hole in a segment 20 of bag 20.

[0097] Referring once more to FIG. 2, the second filter component 60 is affixed to filter component 60 by insertion of male fitting 84 of component 60 into female fitting 80 of component 60, being conventionally interconnected. Note that this interconnection can be disconnected for removal of filter component 60 and, if desired another filter component can be thereby replaced.

[0098] Selection of an effective eye drop bottle is critical to the safety and effectiveness of the instant invention. As such, the eye drop bottle must be able to be securely capped and closed to preserve sterility while still being disposed within bag 20. Also, because a prolonged period of time (e.g. four to six weeks) may pass from time of mixing and bottle filling until use, a desired product SAL must be maintained until use. In addition, as the eye drops are used at a prescribed rate, eye drop accuracy and precision is important. For this reason, an eye drop bottle (called Novelia (Novelia)) commercially available from Nemera, an international company originated in France, is preferred for use in products made by the instant invention. Nemera states the following concerning Novelia: [0099] Preservatives have been shown to be harmful to the eye and can lead patients to discontinue or skip treatment to avoid irritation and discomfort. The new multidose ophthalmic packaging Novelia avoids the need for preservatives in the drug by preventing contamination of unpreserved formulations. Novelia represents a major innovation in ophthalmic drug delivery by providing a preservative free alternative for chronic treatments in a patient friendly package. Novelia has been well accepted by patients in over 45 countries worldwide, including U.S., European, Latin American and Asian countries. It is used for packaging drug products as well as medical devices. The key benefit for patients is that it can be used as a classic multidose eyedropper. This device is able to calibrate droplets, which improves compliance. Its blue tip allows better precision when targeting the eye and bottles are easy to squeeze. Novelia is also more sustainable and affordable than unit-doses, and easier to carry. For ophthalmic pharmaceutical companies, Novelia offers major advantages: [0100] 30% controlled and safe thanks to patented PureFlow technology [0101] Functional with emulsions, suspensions and solution up to high viscosities [0102] Compatible with most existing filling lines (screw cap) [0103] The key requirement for such a device is microbiological sterility; Novelia has been tested and confirmed for content sterility and drop non-contamination for treatment duration (90 days). Novelia represents a major innovation in ophthalmic drug delivery devices by providing patients with a preservative free alternative for chronic treatments, with a patient-friendly package.

[0104] Reference is now made to FIGS. 4 and 5 wherein elements of the preferred bottle 4 and cap 6 for the invention are respectively seen. In FIG. 4, eye dropper bottle 4 is seen to comprise an open, superiorly disposed filling orifice 102, a raised thread pattern 104 whereby cap 6 is affixed to bottle 4 and a locking ring 106 whereby cap 6 is securely locked to bottle 4 by continuing rotation about pattern 104. Bottle 4 also comprises a large vessel portion 108 which is sized and shaped to hold a predetermined volume of product.

[0105] Cap 6, seen in FIG. 5, comprises two basic sections, a superior section 112 and an inferior section 114. Superior section 112 is formed as a displaceable lid which is attached via a threaded interface (not shown) to section 114. When section 112 is disposed in abutting contact with section 114 and securely affixed to bottle 4, bottle 4 is sealed closed. Cap 6 is rotated about the threaded interface between section 112 and 114 to open bottle 4 for eye drop dispensing as disclosed by Nemera (supra). A locking interface (not shown) within section 114 securely affixes cap 6 to bottle 4 when cap 6 is fully turned about thread pattern 104 (see FIG. 4) and thereby close bottle 4 orifice 102. For purposes, disclosed in detail hereafter, outer surface 115 of section 112 is treated to change the coefficient of friction between surface 115 and bag 20 interior surface.

[0106] Reference is now a made to FIG. 6 wherein tray 2 is seen with a plurality of empty cavities generally numbered 5 and 7. Each cavity 5 is sized and shaped to provide inferiorly disposed pressure about an inserted bottle 4. Such inferiorly disposed pressure restricts bottle rotation when cap 6 is affixed to bottle 4. Inferior application of retaining pressure permits bottle 4 to be popped free from tray 2 for independent use after being displaced from bag 20. Each cavity 7, similar to cavity 5, is sized and shaped to retain a cap 6 during transport and before being displaced for capping a bottle 2 while being disposed in bag 20. Further, exterior surface 115 (see FIG. 5) is treated with an overcoat of a substance which substantively increase the coefficient of friction between bag 20 inner surface and section 112. Without such treatment the interface between bag 20 and cap 6 would be slick making digital grasping difficult, if not impossible to accomplish. With the treatment, digital displacement of cap 6 is made facile and sure, a feature which is critical to the instant inventive method. Tray 2 is seen to be filled with bottles 4 and caps 6 in FIG. 1.

[0107] To complete kit 10 assembly, tray 2 filled with bottles 4 and caps 6 is displaced into bag 20 as seen in FIG. 7. Then bag 20 is securely closed by a heat seal 130 to complete assembly as a final assembly step. So closed and sealed bag 20 is sterilized along with all implements of convenience kit 10 contained therein, preferably by gamma radiation. Thus, an enclosed, qualified SAL space, inside bag 20, which is only accessible through sterilizing filter 50 through pathway 70 is created according to the instant invention. Note that filter component 60 is not seen in FIG. 7 as sterility of component 60 is not required, making component 60 a field replaceable component.

Eye Drop Preparation Steps

[0108] Blood is preferably accessed from a patient for preparing autologous blood eye drops; using Becton Dickinson Vacutainers, samples of which are commonly numbered 150 and seen in FIG. 8; by conventional technique.

[0109] Items which are provided as part of a larger kit are seen in FIG. 10. These items comprise:

[0110] 1. A first conventional medical syringe 200 which is specified to have a capacity for accessing and containing the total liquid volume of all vessels 108 of bottles 4 in convenience kit 10.

[0111] 2. A second medical syringe 210 having the same liquid volume as syringe 200 and having a female/female fitting 212 affixed thereto.

[0112] 3. A Vacutainer access barrel 220.

[0113] 4. A plurality of conventional pre-filled normal saline syringes, generally numbered 230.

Each of items listed in 1-3, above, can be provided clean (as opposed to sterile) because all fluid which contacts these items is sterilized upon being dispensed through pathway 70 of filter component 60 into bag 20. For the same reasons, filter component 60 can be provided clean. For safety, prefilled syringes 230 should be pre-sterilized.
Preparation for filling bottles 4 involves:

[0114] 1. Prescribing a ratio of serum to saline to be mixed and form a desired mixture which is used as autologous blood eye drops.

[0115] 2, Following conventional procedures for: [0116] a. Drawing a prescribed volume of blood from a patient (preferably into evacuated tubes (e.g. Becton Dickinson Vacutainers), generally numbered 150, as seen in FIG. 8. [0117] b. Separating patient serum from other blood constituents by centrifuging each evacuated tube 150 and then meting out serum from other blood constituents. For this procedure, a conventional evacuated tube access barrel 232 is preferred to be used (seen in FIG. 9, along with an evacuated tube 150 disposed for insertion into barrel 232). Separated serum is drawn into syringe 200 from barrel 232, interconnected, as seen in FIG. 10A.

[0118] 3. Using conventionally provided indicia (not shown in FIG. 10) on syringe 200 barrel or determining by weight a measure of the volume of patient serum 240 collected in syringe 200 as shown in FIG. 11.

[0119] 4. Referencing the prescribed saline/serum ratio, determining the amount of saline which must be added to the acquired blood volume to formulate each predetermined dose. Two methods for determining saline volume are currently preferred. However, other methods may be used within the scope of the instant invention. A first method is via a chart 242 such as the one seen, by example, in FIG. 12. As an example, if the dose serum to saline ratio is 20% to 80%, respectively and the measured amount of serum is 8.4 mL, a value of 8.4 is located under the 20% Serum column heading and a straight horizontal line (such as line 244 is drawn from the serum value across to the associated saline value which is, within plotting accuracy, 33.6 mL. If a number processing program, like EXCEL is available the saline volume (mLsal) can be calculated from dose (% ser) and measured serum volume (mLser) by the following equation:

mLsal=mLser (100% ser)/(% ser)

[0120] 5. Drawing determined required dose volume of saline (mLsal) into syringe 220 (see FIG. 10) from pre-filled syringes 230, resulting in syringe 210 being partially filled with saline 250 as seen in FIG. 13.

[0121] 6. Affixing syringe 200 to communicate with syringe 210 as seen in FIG. 14, displace contents of syringes 200 and 210 back and forth a predetermined number of times (at least three times is preferred) to assure adequate mixing of serum and saline, with all of the mixture being displaced into a syringe (preferred syringe 200) at the end of the mixing cycle.

[0122] 7. Detaching filled syringe from fitting 212.

[0123] 8. Acquiring kit 10, which may be disposed as seen in FIG. 1B, and digitally clutching filter appliance 50, at bag 20 exterior, and displacing appl;iance 50 upward, as seen in FIG. 15, tents bag 20 for more facile access to items disposed within bag 20. A second hand and may be used in the tenting process as seen in FIG. 15A for assuring tray 2 centering below filter appliance 50 .

[0124] 9. Then, affixing, as seen in FIG. 18, syringe 200 to filter component 60 (or filter component 60, if filter component 60 has been removed) and dispensing a prescribed volume into each bottle 4 via orifice 102 as shown by example in FIG.16. Note that suppleness of bag 20 permits digitally guiding filter appliance 50 into communication with each bottle 4 whereupon liquid is efficaciously dispensed through each orifice 102.

[0125] 10. Capping each bottle 4. Once each bottle 4 is filled with a prescribed dose sterilized to a predetermined SAL, perhaps the most important step still remains, capping and sealing each bottle 4 for delivering bottles into an open environment would otherwise likely detrimentally affect SAL of bottle content. To cap each bottle, each cap 6 (see FIGS. 1, 5 and 7) is digitally accessed one-by-one, by external contact through bag 20 as seen in FIG. 17. As stated supra, as molded, cap 6 has an exterior surface 115 which has a very low coefficient of friction, making virgin caps difficult, if not impossible to grasp effectively. To facilitate digital grasping and displacing cap 6, surface 115 should be coated with a material, such as rubbery Plasti-Dip by Plasti-Dip, International. Once each cap 6 is displaced in contact with bottle 4 about orifice 102, suppleness of bag 20 permits twisting cap 6 and thereby securely affixing each cap 6 and sealing each bottle 4. It should be remembered that, for ease of digital operation from the exterior of bag 20, each cavity 5, in which bottle 4 resides in tray 2, is sized and shaped to restrain bottle 4 from turning as cap 6 is rotated into a closing and locking position. Note that it is a design characteristic of Novelia to lock cap 6 to bottle 4 as a final action of cap 6 bottle 4 attachment, resulting in each bottle 4 being securely capped as seen in FIG. 18. Such locking permits section 112 of cap 6 to be later displaced from section 114 for dispensing eye drops.

[0126] 11. Providing a protected product for use outside bag 20. Once all bottles 4 are filled and capped, bag 20 is accessed for delivering eye drops to a patient, additional care should be provided for, while the product is sterile to a given SAL, the product contains material which is life based. To aid in maintaining at a predetermined SAL, it is highly recommended that a means for keeping eye drop liquids at a low temperature throughout transport and storage. For this purpose, an insulated bag 300 and an associated ice pack 310 (seen in FIGS. 19 and 20, respectively) be provided as part of the larger kit. Such insulated bags and ice pack are commercially available.

[0127] The invention may be embodied in many other specific forms without departing from the spirit or essential characteristics thereof. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.