Abstract: The invention provides a diphtheria, tetanus and pertussis vaccine comprising a low dose of each of diphtheria toxoid (D), tetanus toxoid (T), pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (69K). The vaccine maintains an ability to prevent pertussis while showing exceptionally low reactogenicity. Combination vaccines comprising additional antigens are also provided.

Abstract: A process for preparing a lyophilized material, providing a container having a penetrable envelope and containing the material in a carrier liquid, whereby the penetrable region is penetrated with a penetrator which provides a conduit through the envelope, and the carrier liquid is evaporated out of the container via the conduit, after which the penetrator is withdrawn.

Abstract: A process for preparing a lyophilized material, providing a container having a penetrable envelope and containing the material in a carrier liquid, whereby the penetrable region is penetrated with a penetrator which provides a conduit through the envelope, and the carrier liquid is evaporated out of the container via the conduit, after which the penetrator is withdrawn.

Abstract: A closure system for a pharmaceutical vial, comprising an elastomer closure part, a clamp part which holds the closure part in engagement with the mouth of the vial, and a cover part which engages with the clamp part. The interior of the closure part is profiled to minimize retention of residual liquid therein.

Abstract: A novel elastomer material having an absorption coefficient for laser light of 0.5-2.5 mm?1, preferably being a base thermoplastic elastomer compounded with a colorant which comprises a Pantone 4597C pigment mixed with a carrier material. The elastomer is suited for use as a pharmaceutical vial closure which can be punctured by a filling needle and the puncture hole heat sealed by a focused laser.

Abstract: A process for making a medicinal vial in which a vial and a closure are moulded in parallel in respective vial and closure moulds, then the closure and vial are automatically assembled together, all in a sterile environment. An apparatus for performing this process is also provided. By the process and apparatus of the invention sealed vials with a sterile interior may be made.

Abstract: A process for preparing a lyophilized material, providing a container having a penetrable envelope and containing the material in a carrier liquid, whereby the penetrable region is penetrated with a penetrator which provides a conduit through the envelope, and the carrier liquid id evaporated out of the container via the conduit, after which the penetrator is withdrawn. Apparatus suitable for performing the process is also disclosed.

Abstract: A system for making a connection between the interior and exterior of a compartment, comprising a door opening through the compartment wall, a connector body which can engage with the wall, and having a connection port through it, and a removable cover on the connector body. The body is engaged with the door opening, and an inner door within the compartment engages and removes the cover. A preferred construction creates a single line of confidence seal. The system is particularly suited for sterile compartments.

Abstract: A process for filing a syringe in which a longitudinal tubular syringe barrel has a first end closed by a movable plunger and a connection suitable for an injection needle at its second end, this second end of the bore being closed by a penetrable closure, and the syringe is filled by passing a filling needle through the penetrable closure and filing the barrel with a liquid via the needle, then withdrawing the filing needle from the closure. Suitably a penetrator is attached to the second end of the barrel to penetrate and provide communication through the closure.

Abstract: Apparatus for introducing a medicament into containers, especially vials, in which the containers are passed through an enclosure and exposed therein to a sterilising electron beam. The containers are then conveyed to a filling station situated outside the enclosure at which a wall part of the container is punctured with a filling needle and medicament introduced into the container via the needle then withdrawing the needle. Preferred apparatus also includes means for heat sealing the puncture site. A corresponding process is disclosed.

Abstract: Holding means for holding an article onto a conveyor system, particularly for holding pharmaceutical vials onto a conveyor system for performing a filling and sealing operation thereon. The holding means bears downwardly on the article. A conveyor system incorporating the holding means is also provided. In a further aspect an aerodynamically shrouded processing station for use with the conveyor is provided which minimizes disruption of a downward laminar flow of purified air.

Abstract: A system for making a connection between the interior and exterior of a compartment, comprising a door opening through the compartment wall, a connector body which can engage with the wall, and having a connection port through it, and a removable cover on the connector body. The body is engaged with the door opening, and an inner door within the compartment engages and removes the cover. A preferred construction creates a single line of confidence seal. The system is particularly suited for sterile compartments.

Abstract: A novel elastomer material having an absorption coefficient for laser light of 0.5-2.5 mm?1, preferably being a base thermoplastic elastomer compounded with a colourant which comprises a Pantone 4597C pigment mixed with a carrier material. The elastomer is suited for use as a pharmaceutical vial closure which can be punctured by a filling needle and the puncture hole heat sealed by a focused laser.

Abstract: A system for making a connection between the interior and exterior of a compartment, comprising a door opening through the compartment wall, a connector body which can engage with the wall, and having a connection port through it, and a removable cover on the connector body. The body is engaged with the door opening, and an inner door within the compartment engages and removes the cover. A preferred construction creates a single line of confidence seal. The system is particularly suited for sterile compartments.

Abstract: An apparatus for introducing a liquid into a pharmaceutical container such as a vial, having a puncturable closure, comprising a hollow needle with at least one orifice through the needle side wall being oriented to direct liquid flowing along the bore in a direction having a component parallel to the flow direction, with a vent groove in its outer surface. A preferred construction of needle and a process for making it are disclosed.

Abstract: A process for making a medicinal vial in which a vial and a closure are moulded in parallel in respective vial and closure moulds, then the closure and vial are automatically assembled together, all in a sterile environment. An apparatus for performing this process is also provided. By the process and apparatus of the invention sealed vials with a sterile interior may be made.

Abstract: Apparatus for introducing a medicament into containers, especially vials, in which the containers are passed through an enclosure and exposed therein to a sterilising electron beam. The containers are then conveyed to a filling station situated outside the enclosure at which a wall part of the container is punctured with a filling needle and medicament introduced into the container via the needle then withdrawing the needle. Preferred apparatus also includes means for heat sealing the puncture site. A corresponding process is disclosed.

Abstract: A closure system for a pharmaceutical vial, comprising an elastomer closure part, a clamp part which holds the closure part in engagement with the mouth of the vial, and a cover part which engages with the clamp part. The interior of the closure part is profiled to minimize retention of residual liquid therein.