A method of filling, sealing and sterilizing a pharmaceutical package including a polypropylene bottle containing a balanced salt solution includes the steps of filling each bottle to maximum capacity to exclude residual air, the introduction of a silicone rubber gasket into the bottle cap to absorb pressure and prevent leakage during a steam sterilization procedure, and the enclosure of the filled bottles in a blister pack before steam sterilizing. The blister packs have Tyvek.TM. lids and are placed blister-side-up during the sterilization process to eliminate deformation of the blister during sterilization. Maximum filling of the bottle with liquid and the substantial elimination of air prevents dimpling of the bottle.
This application is a continuation application of my co-pending application Ser. No. 07/273,605, filed on Nov. 21, 1988, now U.S. Pat. No. 4,947,620, which, in turn, is a continuation of Ser. No. 07/137,436, filed on Dec. 23, 1987, now U.S. Pat. No. 4,805,377.
A process for the external decontamination of a packaged object, the latter comprising the object proper, at least the external surface of which is in the decontaminated state, for example sterile, a closed wrapper containing said object, the interior of which is in the decontaminated state, for example sterile, as well as a means of filtration, said process comprising a step of decontaminating the external surface of the wrapper, wherein, before the step of decontaminating the external surface of the wrapper: a) at least two parts and are formed in the wrapper, these respectively determining two compartments and which are leaktight with respect to one another, a first part containing said object, and a second part comprising the whole of the filtration means; b) the second part is separated from the first part, while preserving the leaktightness of the first compartment; then the first part alone is subjected to the step of decontaminating the external surface of the wrapper.
A medical package has a tub and a lid. The tub has a four-sided base with walls extending upwards therefrom; the walls terminate at a first flange with extends outwardly. From the first flange, four top walls extend upward and terminate at a second flange which extends outwardly. The tub is formed of a clear, ultraviolet light transmitting plastic. The lid has a gas permeable, microfiber central portion surrounded by a clear, ultraviolet light transmitting plastic film. The film has a high shear resistance and does not produce particulate matter during an opening procedure.
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.
A double thickness label assembly has a label layer having a pressure sensitive adhesive mounted on a backing layer. The backing layer has a release coating for removal of the labels. The label assembly is divided into two or more sections by perforations that extend through both layers of the assembly. Each individual section is designed to have increased flexibility at its leading edge by means of die cut and/or perforated lines so that the section can feed through a laser printer without getting jammed. The user may choose to either print the sheet in its entirety, or may print one or more sections and save the remainder of the sheet for later use. A convenient method of preparing small sets of labels uses a divisible sheet of labels that is divided into sections by perforations. A user first divides the sheet into the sections. Each section includes a number of die cut labels. The user then adjusts the feeding mechanism on a laser printer to the width of the section sheets, then prints the labels on the section sheets.
A method for a single step sterilization of a ready-pack, such as a blister pack, in an autoclave is described. The ready pack includes a container, such as a syringe, filled with a substance. The environment in the autoclave, that is, the temperature, the heating period and, preferably, the pressure is controlled to sterilize simultaneously the ready-pack and its contents by circulating steam in the autoclave. The steam penetrates into the blister pack through a steam-permeable base. The temperature is maintained between about 120.degree. C. to 130.degree. C. for about 15-20 minutes.
