Abstract: A sterilization device which includes an inner sterilization wrap and a re-usable outer sterilization bag. The re-usable outer sterilization bag has an outside surface and an inside surface defining a pouch with an opening for receiving the inner sterilization wrap and a sterilizable object. The material is preferably a spunbonded or meltblown polyolefin fiber non-woven breathable web. Also provided are methods of sterilizing an object, and methods of using a sterilizable bag.

Abstract: A package for sterilized, absorbable medical devices is disclosed. The package has a plurality of cavities in communication with a vent, wherein the vent is preferably centrally located. After sterilization, the package is sealed adjacent to the vent thereby providing individual hermetically sealed sterile cavities which are cut away from the package to form unitary packages.

Abstract: A self-venting package (A) contains peracetic acid or other strong oxidants in a unit dose that assures sterilization of instruments and equipment in an automated sterilizing apparatus (FIG. 3) or of biological wastes in a biological waste comminuting apparatus (FIG. 4). The self-venting package is constructed of a cylindrical body having first and second vent apertures (12, 14) 180.degree. offset adjacent a first edge (20) and third and fourth vent apertures (16, 18) 180.degree. offset adjacent a second edge (26). The first and second vent apertures are 90.degree. offset relative to the third and fourth vent apertures. The first edge is flattened and sealed forming a pair of corners (40, 42) such that the first and second vent apertures are disposed closely adjacent the first and second corners. The container is filled with peracetic acid or other liquids which liberate gas or vapors. A second end (26) of the container is flattened and sealed in a direction transverse to the first edge.

Abstract: The invention provides a sealed package system for housing at least one medical electrode apparatus and for enabling the periodic testing thereof, comprising a thin, generally flat flexible envelope constructed and arranged to form an interior cavity for enclosing a conductive gel contact surface of an electrode apparatus, the envelope having at least one continuous layer of a homogeneous, non-conductive, polymeric material, the envelope further having first and second sides; and a structure for conducting current across the envelope to the interior cavity, the conductive structure being electrically connectible to the electrode conductive contact surface.

Abstract: A method of transporting cells in culture commences with the provisions of a multiwell plastic plate, wherein at least one well contains a sample of cells. A sheet of sterile adhesive film is applied to the top of the plate with sufficient pressure to seal the sample of cells into the well. The sterile adhesive film and the multiwell plate are covered with a plate cover, with a flexible plastic pad being optionally inserted between the sheet of sterile adhesive film and the plate cover. This method can be practiced with a kit containing these components in a unitized package.

Abstract: A peel-open package includes a polymeric film, a lid adhered to the polymeric film along a continuous portion thereof and a product encapsulated between the polymeric film and lid material. The polymeric film is typically a coextruded multiple layer film having a sealable layer and at least one base layer. The sealable layer comprises an ethylene copolymer derived from at least one monomer selected from the group consisting of vinyl acetate and alkylacrylates, a talc additive, and an additive which provides peelability to the heat seal layer. The lid material is preferably a microporous layer to allow sterilization and prevent subsequent contamination by bacteria and other microbial organisms. The peel-open package provides a good seal range for uncoated Tyvek.RTM., evidence of seal integrity, reduced Tinting, and a seal strength which is sufficiently low to prevent the delaminating or branching of the lid material when it is removed. The present invention also includes methods of making peel-open packages.

Abstract: A tray and process for hydrogen peroxide vapor sterilization of medical articles. The tray includes a bottom surface and side walls defining a space to receive articles to be sterilized. The bottom surface of the tray includes a number of inlet passages and wells with a known volume. In the process of the present invention, articles to be sterilized are placed in the tray, and aqueous solutions of hydrogen peroxide is delivered into the tray. When the excess hydrogen peroxide is drained through the inlet passages, a known volume of peroxide remains in the wells. Such remaining hydrogen peroxide is then vaporized to achieve sterilization.

Abstract: A breathable packaging material used for packaging items, such as floral groupings, flower pots, fresh produce, food, medical supplies/equipment, pharmaceutical products, and the like, thereby forming a breathable package for containing said items. The breathable packaging material comprises a sheet of material having controlled atmosphere characteristics, and having a desiccant and/or an antimicrobial agent. Methods for using breathable packaging material.

Abstract: A system for storing and sterilizing orthopedic devices in a series of cases that may be attached together to provide a custom type container for a particular end user. The containers have modular compartments for housing the orthopedic devices. The containers may be shipped with the orthopedic devices in a sterilized environment as well as be resterilized in an autoclave for future use. A method of use and inventory control is also disclosed wherein a container using a generic marking system is used on the lid for the container. An inventory control sheet is used to record the part number and manufacturing lot number of the components housed in the compartments. The sheet corresponds to the generic marking system. A more accurate accounting of the inventory is achieved.

Abstract: A receptacle (10) is constructed having first and second broad sides connected along side and bottom edges (12) and (14), respectively. These sides are in turn constructed of an outer layer (28) of flexible, durable fabric material, and in one embodiment, an inner layer (26) of the fabric material. In this embodiment, a barrier material (24) may be placed between the inner and outer layers of at least one of the sides. In a preferred embodiment, a flap closure (20) configured as a cuff (40) extends from one of the sides adjacent opening (18), and folds over opening (18) so as to close the opening.

Abstract: An apparatus and associated method which detects breaks and irregularities in a sealing arrangement, especially in heat-sealed, sterile packages by providing a standardized verification bar on the package adjacent a color coded sealing area. The verification bar may indicate examples of a proper seal, an underseal, and an overseal, as well as common seal problems such as bubbles, hairline voids and regular coextensive voids. The package which is especially useful as a sterilization pouch can be visually inspected both by the user of the package contents just prior to use and by the vendor of articles in the packages post assembly of the article into the sealed and sterilized package.

Abstract: An instrument cassette and sterile wrap assembly includes a base having an upright sidewall and a horizontal bottom wall, the upright sidewall having a lower slot and an upper aperture defined therein. The assembly includes a latch member having a lower section, an intermediate section and an upper section, wherein (1) the lower section extends through the slot defined in the base, (2) the intermediate section is substantially planar, and (3) the upper section (i) extends through the upper aperture defined in the base, and (ii) has a slot defined therein. The assembly further includes a lid having a horizontal top wall and a tongue member attached thereto, wherein the tongue member extends through the slot defined in the upper section of the latch member when the lid is latched to the base.

Abstract: A reusable sterilization pouch 10 comprises a pair of sheets 7, 9 that provide first and second sides 12, 14 of the pouch, and a closure 16. The sheets are edge-bonded along both side edges and along the bottom edge to provide sealing seams 13, 15 and 17, respectively. The closure 16 comprises a transverse open-ended channel 19 extended across the top of the pouch and a closure strip 18 that is inserted through the channel 19. Channel 19 is large enough that closure strip 18 can be manually inserted therethrough; channel 19 may be slightly larger, but it should not be so large that closure strip 18 would be so loosely contained that it could fall out of the channel when the pouch 10 is held or tilted on edge. Channel 19 is formed by doubling or folding one end of the sheet 9, comprising side 14, back onto itself and edge-bonding the overlap to provide a transverse seam 20.

Abstract: A surgical container for sterilizing, transporting and storing small surgical instruments such as drill, pins, screws and the like. The container comprises a base having at least one well, and includes an apertured plate for holding the instruments, covering the well at least in part. The apertured plate has apertures sized to accommodate selected instruments, and a cover rotatably mounted over the apertured plate. The cover has an opening for providing access to a limited area of the plate and any instruments loaded therein.

Abstract: Disclosed herein is a single step sterilization wrapping material suitable for use, as an example, in wrapping surgical instruments and supplies for sterilization, transportation and storage. The material includes separate inner and outer wraps which, unlike previous wraps, are joined to one another. Common wrapping techniques involve wrapping items to be sterilized with two separate sheets of wrap. The present invention provides separate wraps which can be specially engineered to deliver specific properties for each sheet and then joined to one another so as to permit wrapping and opening in a neat single step process which increases efficiency and saves time and money. In special situations the outer wrap can be engineered with increased strength, the inner wrap with increased barrier properties and the inner and outer wraps can be made visually distinct from one another so that improper wrapping or opening is not a problem.

Abstract: A high temperature steam-sterilizable flexible pouch package includes a non-woven barrier web, a perforated plastic intermediate web, and an imperforate plastic upper web. Line heat seals bonding the webs form a cavity into which high temperature sterilizing steam may enter after passing through the barrier and intermediate webs. The line heat seal bonding the upper and intermediate webs is of the delamination failure type. An access opening is provided for insertion of an object to be sterilized into the cavity after which the access opening is sealed, enclosing the object in the cavity. After high temperature steam sterilizing, the package is opened by peeling apart the upper web from the intermediate web which causes a delamination failure of the line heat seal. Preferred materials enable vacuum cycle steam sterilization at a temperature of at least 270.degree. F.

Abstract: Devices useful to monitor whether or not an article has been exposed to sterilizing conditions are provided and comprise a package and an indicator associated with the package. The package is sufficiently permeable to admit sterilizing gas or vapor into the package. The indicator associated with the package changes color from a first color (indicating ambient conditions) to a second color (indicating exposure to acidic gas or vapor). Both the first and second colors of the indicator are stable and preferably substantially maintain their colors under ambient conditions. Particularly, preferred embodiments are adapted for use with peracetic acid sterilization processes.

Abstract: A surgical container for sterilizing, transporting and storing small surgical instruments such as drill, pins, screws and the like. The container comprises a base having at least one well, and includes an apertured plate for holding the instruments, covering the well at least in part. The apertured plate has apertures sized to accommodate selected instruments, and a cover rotatably mounted over the apertured plate. The cover has an opening for providing access to a limited area of the plate and any instruments loaded therein.

Abstract: A double-sterile package for critical-use medical apparatus includes an inner first container including an outer boundary wall impervious to microorganisms and being closed except for defining a hole. A patch of gas-permeable micro-porous sheet material is secured to the outer boundary wall spanning and closing the hole. The gas-permeable sheet material is sufficient to exclude environmental microorganisms from entering the inner first container. The first container is received into and nested within a conformal second container also having a boundary wall impervious to microorganisms and being closed except for defining a hole. This hole of the second container is also closed by a patch of the gas-permeable micro-porous sheet material, and the holes of the first and second containers are in gas-flow communication with one another. The medical apparatus within the nested containers is sterilized by evacuation of air and introduction of a sterilizing gas via the gas-permeable patches.

Abstract: A package and a method for making a package which allows for the central processing of fresh red meat is disclosed which includes a tray, a first film enclosing the product within the tray and a second film, which is removed at retail, enclosing the first film. The first film and the second film are sealed to the inner periphery and the outer periphery, respectively, of the single flange of a conventional foamed or nonfoamed tray. The first film is a heat shrinkable film which is sealed to the inner periphery of the flange forming a first seal, trimmed outboard of the first seal, thereby forming an excess portion of the first film outboard of the first seal, and then subjected to a sufficiently high temperature to shrink the excess portion and thereby expose a sealing area on the outer periphery of the flange. The second film is then sealed to the sealing area on the outer periphery of the flange, forming a second seal such that the second film encloses the first film.

Abstract: A sterilizable flexible pouch package includes a non-woven barrier web, a perforated plastic intermediate web, and an imperforate plastic upper web. Line heat seals bonding the webs from a cavity into which sterilizing steam may enter after passing through the barrier and intermediate webs. The line heat seal bonding the upper and intermediate webs is of the delamination failure type. An access opening is provided for insertion of an object to be sterilized into the cavity after which the access opening is sealed, enclosing the object in the cavity. After sterilizing, the package is opened by peeling apart the upper web from the intermediate web which causes a delamination failure of the line heat seal. Preferred materials enable steam sterilization at temperature of 270.degree. F.

Abstract: A container for the sterilization of articles disposed therein, including surgical instruments, having a base unit and a matching cover unit. A locking mechanism, including a C-shaped tab, is pivotally and removably attached to each end of the base unit so that each tab can pivot between an open and a locked position. Each tab includes a first locking ridge located on an upper portion of the tab. The cover unit includes a second locking ridge located at each end of the cover unit for interfitting with the first locking ridge of the corresponding tab when the tab is in the locked position.

Abstract: A sterilizable package having at least one flexible plastic wall, and having an access opening therein covered by a peelable two layered tear strip, including a porous membrane and a plastic interlayer, which interlayer has an opening substantially matching the access opening, where the opening in the plastic interlayer is 25% or more of the width of the interlayer. The interlayer is kept from deforming during fabrication of the pouch by tack sealing it to the flexible wall of the package, and cutting the access opening and the opening in the interlayer simultaneously after the interlayer is tack sealed to the front sheet.

Abstract: A sterilization container for medical instruments comprising a closure having upper and lower members sealingly fastened together. Apertures are provided in the upper portion of the closure and a layer of material overlaps the apertures on the inside of the upper member so that under selected heat and humidity conditions vapors are allowed to pass through the apertures and the paper but under lower heat and humidity conditions the paper is dry and prevents the passage of vapor therethrough.

Abstract: A metal autoclave cassette for dental instruments and appliances includes a pair of identical tray halves which are free of any outwardly extending flanges and which are provided with rounded corners and corner edges. Each tray half includes a retaining frame which is riveted in place and which includes a plurality of aligned recesses in the opposite ends. The recesses are used for the receipt of the elongate dental instrument's and a hold down mechanism clamps the instruments into position yet is easily moved out of position to provide access to the dental instruments.

Abstract: A sterilization tray assembly for sterilizing, transporting and storing surgical instruments, having top and bottom mating enclosures. The mating enclosures each have a plurality of ports for permitting ingress and egress of gaseous sterilant. A rack is rotatably mounted within the enclosure, and has a plurality of spaced apertures into which surgical instruments may be removably inserted.

Abstract: An autoclave bag having an outer ply of mesh fabric with interstices formed throughout the mesh, an inner ply of a film of synthetic polymer, and an intermediate, adhesive ply bonding the outer and inner plies and entering the interstices of the outer ply.

Abstract: A transparent packaging laminate (10) for use in a container (15) for protecting medical products (18) from oxidation and deterioration as a result of exposure to ultraviolet light. The laminate includes a first transparent film (11) of a polyethylene material laminated with a polyester adhesive (13) to a second transparent film (12) of a polyester material. The transparent polyethylene material has a water vapor transmission rate of less than 20 grams/m.sup.2 /24 hours. The transparent polyester material absorbs ultraviolet light having a wavelength in a range of from 285 to 358 nanometers and has a water vapor transmission rate greater than 20 grams/m.sup.2 /24 hours, whereby the resulting laminate is unexpectedly wrinkle-free after ethylene oxide sterilization.

Abstract: A medical instrument sterilization container (10) is provided which includes a port (18). A removable filter (32) is received within port (18) to enable sterilization of instruments placed within container (10). A removable plug (48) replaces filter (32) to enable container (10) to be used to transport instruments without leaking of fluids therefrom.

Abstract: A steam sterilizable pouch is disclosed. The pouch includes a non-woven steam-permeable bottom web. A multi-layer intermediate web is bonded to the bottom web. The multi-layer web is substantially steam impermeable, except for a perforated steam-permeable region. The intermediate web includes top and bottom layers. A steam-impermeable top web is bonded by a first line heat seal to the top layer of the intermediate web. A cavity having a heat sealable access opening is located between the top web and the top layer. At least a portion of the first line heat seal is peelable after steam sterilization of the pouch at 270.degree. F., the peel strength being from 3/4 to 5 pounds per inch. The bonding of the intermediate web to the bottom web is by a second line heat seal that is located peripherally outside of the perforated steam permeable region of the intermediate web.

Abstract: A sterilization container for sterilizing and storing medical instruments includes a base tray and one or more insert trays removably mounted in a cavity defined by the side and bottom walls of the base tray. Insert trays are supported on ribs projecting transversely into the base tray cavity which cooperates with the side walls of the base tray to define a groove which receives a circumferential wall defined on a turned over portion of an insert tray, thereby inhibiting the latter from migrating to the bottom of the base tray. The ribs have lateral side surface to engage the circumferentially extending wall of the insert trays to restrict lateral movement of the insert trays relative to the base tray to that distance which brings the circumferentially extending walls of the base tray into engagement with the lateral surface of one of the ribs.

Abstract: Packaging, particularly for medical supplies and devices, is made from spunbonded olefin sheet material. At least a portion of the olefin sheet material is deformed to increase its surface area by between 4 and 60 percent, so as to create a pocket of a dimension sufficient to envelope the medical supply or device. After the medical supply is placed within the pocket, it is covered and sealed by another sheet having microbial barrier characteristics. Even though deformed, the spunbonded olefin packaging possesses the ability to allow quick passage of sterilizing gas, yet is resistant to penetration by contaminating microorganisms.

Abstract: A packaging for the protective sterile containment of a rigid product and, more particularly, a sealed container protectively enclosing the sterile product, such as a liquid-filled vial, during shipment and handling of the packaging, and upon opening of the packaging in a sterile environment; for instance, a surgical operating room, facilitating the sterile transfer of the product from the packaging into the sterile environment.

Abstract: The container for packing hollow endoprostheses (8) comprises two germ-proof wrappings (1, 2). In accordance with the invention the inner wrapping (1) consists of a water-tight wall (10, 11) and various connection points (40, 50, 60). At least two of the connection points (40) are provided as access into the cavity of the prosthesis (8) and one is provided as an outlet (50) for liquids for treating the prosthesis. The outer wrapping (2) comprises through-pieces (42, 52, 62), which are associated with the connection points of the inner wrapping. The two wrappings are permeable to gas at least some regions. In accordance with the invention the container has a second application apart from its protective function: for example, in the case of a hybrid prosthesis for vascular replacement, to perform the charging of the prosthesis with the patient's own endothelial cells in the container.

Abstract: In a sterilizing container for medical and surgical instruments comprising a box with a bottom part and a cover for sealing the bottom part in a germ-tight manner, the side walls of the bottom part of the box have openings covered on the outside with germ-tight but sterilization gas permeable filter layers which are held in position by retaining plates mounted on the side walls, the cover of the box being locked to the bottom part by a locking structure formed at one end of the box at which the cover and bottom part includes retaining structures receiving a safety tag which covers the locking structure when the cover is closed in such a way that the safety tag is firmly positioned in front of the locking structure and the locking structure is only accessible by destroying the safety tag.

Abstract: A vacuum-formed storage tray for autoclaving medical and dental instruments includes a base panel surrounded by a plurality of integrally joined sidewalls so as to create an interior storage area. The base panel defines a plurality of sterilant apertures. The base panel and sidewalls are created by a vacuum-forming operation which concurrently creates by vacuum forming a plurality of aperture bosses. The vacuum-formed aperture bosses are closed as formed and must be subjected to a post-forming machining operation to cut off the closed end of each aperture boss. Once the closed ends are cut off, the closed aperture bosses become open sterilant apertures. The creation of a plurality of sterilant apertures by a vacuum-forming operation can replace any drilling operations for sterilant holes and economically allows greater variety as to the style and shape of apertures which can be formed in the base panel of the storage tray.

Abstract: A medical instrument sterilization processing pouch is provided having a sterile processing indicator protected between the walls forming the pouch to register sterilizing processing of the medical instruments.

Abstract: A sterile inoculation assembly includes an inoculation device (20), a storage container (84) and a handling tool (60). The inoculation device (20) includes an elongated body (22) having an inoculation end (26) and an opposed gripping end (24). The container (84) is formed with at least one cavity (86) with an opening (88) thereto. The cavity (86) is dimensioned to receive the inoculation device (20) in an orientation which permits the gripping end (24) to be grasped through the opening (88). A sheet-like cover (98) is positioned across the opening (88) to seal it and to retain the inoculation device (20) in the cavity (86). The cover (98) is capable of being punctured for grasping of the gripping end (24) and removal of the inoculation device (20) by a handling tool (60). This handling tool (60) telescopically engages the gripping end (24) for releasible securement thereto.

Abstract: Vacuum-sealed container, including contents and having an upper part and an element integral with the upper part, a housing being defined by the upper part and by the element, containing a solid substance having a melting point between 65.degree. and 150.degree. and including a first orifice communicating with the container and a second orifice communicating with the exterior closed by the solid substance.

Abstract: A package for an active medical device has a film member pocket recess. The member has a planar flange about the recess and a flat wall with an opening. A lid attaches to the flange. Outer and inner parts of a junction conjugate in the opening to seal and insure sterility. Test means on the inner part test means include a transparent window in a central web to permit optical signal transmission and electrical signals pass through a plurality of spaced apart electrically conductive pins about the web to distally couple the device and test linkage. An inner part band with a brim thereabout fits through the opening so the brim faces the wall. An outer part collar with a rim thereabout conjugates with the band that extends through the opening and the rim abuts in tight facing relation the wall. The brim and band support a resilient gasket for compression between the wall and the brim when threads on the band mate with threads on the collar.

Abstract: The invention relates to a sterilizable bag including a large transparent, heat-sealable plastic sheet closed by a filter strip comprising a three ply laminate in which a central layer is a microporous plastic, a second layer provides strength and a third layer provides a heat-sealable surface for bonding to the transparent plastic sheet to close and seal the bag.

Abstract: A locking device in the shape of a unitary body formed from a bio-degradable material which includes an element with at least one free end formed integral with said body. The severable element is designed to engage and secure a container lock mechanism when the container is in a closed position, whereby the free end of the element is capable of being mechanically or adhesively secured to said unitary body to form a seal, with said device being designed to fracture upon opening of the container lock mechanism thereby providing visible evidence of the lock mechanism being opened.

Abstract: A receptacle for containing medical instruments for sterilization is constructed having first and second broad sides connected along side and bottom edges. These sides are in turn constructed of an outer layer of flexible, durable fabric material, an intermediate layer of a plastic film material forming a barrier to microorganisms, and, in a preferred embodiment, an inner layer of the fabric material. A cuff extends from one of the edges adjacent the opening and is invertable over the opening to close the opening.

Abstract: A package for a catheter having a proximal end and a distal end, includes a tube defining a cavity along an elongate axis, the cavity being configured to receive at least the distal end of the catheter. Access means includes a housing fixed to the proximal end of the tube and a cap rotatable to engage the housing in a first position to seal the cavity, and to disengage the housing in a second position to provide access to the cavity. A circumferential tear-strip is configured and disposed to provide a high degree of control over the separation of the housing and cap. An O-ring, which forms a seal between the cap and housing, is disposed relative to a circumferential shoulder which cooperates with a camming surface to cause the cap to pop from the housing when rotated. An associated method includes the steps of rotating the cap a first angular distance to engage the camming surface and a second angular distance to cause the O-ring to traverse the shoulder.

Abstract: A medical instrument sterilization container 90 has a housing 12, a removable tray 16 adapted for holding medical instruments and a removable lid 92. Lid 92 has no apertures or other inlets and is sealingly affixed to the housing 12 so that pressure induced positive drainage occurs providing for significantly improved drying.

Abstract: A medical instruments sterilization container (10) includes a housing (12) and a removable lid (14). A removable tray (16) is adapted to hold various medical instruments to be sterilized. The container is formed of a polymer of relatively low thermal conductivity, with a material having a relatively high thermal conductivity being added thereto in order to substantially increase the overall thermal conductivity of the container to absorb radiant heat and rapidly conduct that heat throughout the container to reduce condensate within the container.

Abstract: A breather package for surgical elements such as sutures or suture-needle assemblies having a layer of fibrous material and a layer of plastic material forming a pocket therebetween. Longitudinal heat seals and transverse top and bottom seals are provided which form the package. The layer of fibrous material is provided with longitudinal strips of release agent material through which the longitudinal heat seals are formed. An apparatus for forming such a package is also disclosed.

Abstract: An improved package for a medical device includes an inner wrap that envelopes the medical device, the inner wrap including a gas-permeable surface, and a chamber defined in the inner wrap to store a hydratable sensor of the medical device. Plumbing for the package controls fluid flow into and within the inner wrap, to selectively establish, without breaching a portion of the inner wrap surrounding the sensor, fluid communication between the gas-permeable surface and the sensor, to sterilize the sensor and the inner wrap with a gaseous sterilant, or to hydrate the sensor with hydration fluid obtained from a source of hydration fluid connected to the chamber, or to equilibrate the hydration fluid in the chamber with an external source of gas, to calibrate the sensor within the inner wrap.

Abstract: A surgical tray system includes an enclosure base, a U-shaped instrument rack removably positioned within the enclosure base and capable of suspending a complete set of surgical operating instruments by their shafts, a flat operative assembly tray that may be locked into position on top of the enclosure base, above the U-shaped instrument rack, for retaining additional surgical instruments in positions that are identified by silkscreened outlines of those additional instruments, and a cover that may be locked into position on top of the operative assembly tray, thereby covering the enclosure base, the U-shaped instrument rack positioned within the enclosure base, and the operative assembly tray. One or more additional trays, such as a diagnostic assembly tray, for retaining additional instruments required in connection with a particular surgical procedure, may be stacked above or below the operative assembly tray or they may be included within a separate tray having its own enclosure base and cover.

Abstract: There is provided a method and apparatus for forming a sterile surgical field including a sheet which may have at least one hole therein and a container which may be received in the hole so that the hole is completely sealed. A package for shipment and storage is formed by placing the sheet inside of the container, covering the container with a lid or a second container, and sealing the container ensuring the sterility of the inside of the container. When the package is opened, the sheet is removed from the inside thereof and spread out. The inside surface of the container and the sheet form a sterile field.