A cleaning method of a heat sterilization system includes: a step of causing a fluid formed of a cleaning liquid or a rinse liquid to flow through the heat sterilization system; a step of supplying hot water to a second-stage heating unit to heat the second-stage heating unit; and a step of measuring fluid temperatures of the fluid at the fluid inlet and the fluid outlet of the second-stage heating unit, and medium temperatures of the hot water at a medium inlet of the second-stage heating unit and a medium outlet of the second-stage heating unit. An overall heat transfer coefficient (U value) of a heating pipe of the second-stage heating unit is calculated based on the fluid temperatures at the fluid inlet and the fluid outlet of the second-stage heating unit and the medium temperatures at the medium inlet and the medium outlet of the second-stage heating unit.

The present invention provides a method for manufacturing filling bag product of tremella mixed raw materials. Firstly, tremella raw material is put into a container of a drying system. Next, the tremella raw material is baked in the container of the drying system to dry the tremella. Then, the dried tremella raw material is placed into a grinder to grind it into tremella powder. Subsequently, the tremella powder is added with formula raw materials to evenly mix in a mixer to form tremella mixed liquid. Then, a filling machine is used to fill the tremella mixed liquid into a small package to form a tremella filling bag product.

The present invention provides a method for manufacturing filling bag product of tremella mixed raw materials. Firstly, tremella raw material is put into a container of a drying system. Next, the tremella raw material is baked in the container of the drying system to dry the tremella. Then, the dried tremella raw material is placed into a grinder to grind it into tremella powder. Subsequently, the tremella powder is added with formula raw materials to evenly mix in a mixer to form tremella mixed liquid. Then, a filling machine is used to fill the tremella mixed liquid into a small package to form a tremella filling bag product.

The present invention relates to a sterile pharmaceutical composition comprising tiotropium or a pharmaceutically acceptable salt thereof, for inhalation via nebulization to a subject (e.g. a human). The invention also relates to a process for preparing the pharmaceutical composition and its use in the treatment of respiratory diseases such as chronic obstructive pulmonary disease (COPD) in a subject.

The present invention relates to a sterile pharmaceutical composition comprising tiotropium or a pharmaceutically acceptable salt thereof, for inhalation via nebulization to a subject (e.g. a human). The invention also relates to a process for preparing the pharmaceutical composition and its use in the treatment of respiratory diseases such as chronic obstructive pulmonary disease (COPD) in a subject.

A multilayer container for elevated temperature, high pressure processing of a material within the container, using a pressure transmission liquid within the container, the multilayer container having a container wall having an inner layer formed of a plastic for containing the liquid in contact with the inner side thereof and at least one further layer outboard of the inner layer and formed of different plastic from the inner layer, wherein the inner layer has a compression heating coefficient at least as high as the compression heating coefficient of the pressure transmission liquid in contact with the inner side thereof and the at least one further layer has a lower thermal conductivity at ambient pressure and temperature than the inner layer.

A multilayer container for elevated temperature, high pressure processing of a material within the container, using a pressure transmission liquid within the container, the multilayer container having a container wall having an inner layer formed of a plastic for containing the liquid in contact with the inner side thereof and at least one further layer outboard of the inner layer and formed of different plastic from the inner layer, wherein the inner layer has a compression heating coefficient at least as high as the compression heating coefficient of the pressure transmission liquid in contact with the inner side thereof and the at least one further layer has a lower thermal conductivity at ambient pressure and temperature than the inner layer.

The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

An injection formulation includes a medical container having an oxygen-permeable container that is filled with a sugammadex sodium aqueous solution containing sugammadex sodium as an effective component and sterilized with high-pressure steam and a poorly oxygen-permeable packaging container, in which (i) the medical container is accommodated and sealed in the poorly oxygen-permeable packaging container together with an oxygen absorber or (ii) the medical container is accommodated and sealed in the poorly oxygen-permeable packaging container purged with an inert gas.

The invention relates to chemical and pharmaceutical industry, in particular to technologies of obtaining sterile drugs, drug substances and cosmetic products used in the form of solutions or emulsions, and comprising poloxamer. The thermal method for sterilizing aqueous poloxamer solutions is provided, the method including: dissolving a poloxamer in water for injection; performing the sterilizing filtration of the aqueous poloxamer solution simultaneously with filling sterile containers with the filtered poloxamer solution; sealing the containers containing the poloxamer solution; applying a thermal sterilization with steam under pressure to the containers containing the poloxamer solution, and cooling them, wherein the thermal sterilization of the containers containing the poloxamer solution with steam under pressure is performed under the pressure between 82.4 and 107.8 kPa.