SU728862A1 - Method of sterilization of rubber articles - Google Patents

Description

I

The invention relates to the field of medicine and is used in the preparation of rubber products, such as stoppers, for sealing bottles with injection medications. The stoppers must ensure that they are stored (while maintaining sterility) hygroscopic and unstable drugs, such as antibiotics, which place a number of special requirements on the preparation of stoppers.

There is a method of sterilizing rubber products, including siliconizing, sterilizing and drying with continuous stirring of products 1.

However, with this method, the fixed bed of products is not uniformly heated during sterilization by direct steam; air dry drying comes from mixing with high relative humidity, and this does not guarantee sterility; drying is carried out with cold air without vacuum, which does not provide such moisture as is required for capping gyroscopic preparations; Siliconization in water is carried out before sterilization and subsequent heating with live steam in the absence of water reduces the elasticity of the products (the plugs become more "rigid"; The equipment for the implementation of the method is very difficult to manufacture, expensive and inefficient. - The filling ratio of the drum is 10 ° / o; loading and unloading of products is done manually.

The aim of the invention is to improve the quality of sterilization products.

This is achieved by the fact that the siliconization is carried out after sterilization, and the mixing in the process of sterilization, siliconization and drying is carried out in a fluidized bed, while drying is carried out under vacuum.

FIG. 1 is a schematic diagram of the installation; in fig. 2 - a general view of the apparatus; in fig. 3 shows section A-A in FIG. 2

The installation includes an autoclave-type apparatus 1, a filter 2 of the steam entering the apparatus, a filter 3 of determining the purity of steam and air, a filter 4 with a steam jacket ALYA sterilizing the air entering the apparatus, a heat exchanger 5 ap heating the air in front of the apparatus, a steam jacket 6 on the drain lines from the apparatus and the air filter, protection against contamination, steam jacket 7, protection against contamination of the air outlet line from the apparatus, barometric condenser 8 for condensation of water vapor leaving the apparatus, hydraulic lock 9 to end a capacitor, a vacuum pump 10 for creating a vacuum in the condenser and in the apparatus.

The device consists of three parts: upper, middle and lower.

The upper part includes a lid 11, a fitting 12 for loading the plugs, a fitting 13 for escaping steam and air, a fitting 14 for loading the silicone. The middle part 15 is made in the form of a truncated cone with an apex angle of 5-15 °, which corresponds to the angle of the opening. The lower part of the apparatus is made in the form of a truncated cone with a vertex angle of 60 ± 10 °, ensuring the formation of a fluidized bed.

The lower part 16 of the apparatus includes a shirt 17 on the case for steam heating, a gas distribution device 18, a grid 19 for holding the plugs, a flange

20dla overlap gas distribution device and for supporting the lattice 19, the cone

21dl seals the bottom hatch, pipe

22dl to drain the fluid from the apparatus, the pipe 23 for supplying air to the gas distribution device and the hatch 24 for unloading products.

Example}. In an autoclave with a capacity of 420 liters load vacuum (pneumatic) from the washing unit 70,000 pieces of rubber stoppers "AB and then pour 100 liters of water. Steam under pressure of not less than 2 MPa heat the mass in the autoclave to 120 ° C (pressure in the autoclave 1.1 MPa) and incubate for 30-45 minutes, then cool to 60 ° C due to evaporation under vacuum and make a sterile silicone emulsion CE - 10-16.

Do not mix by compressed air for 30 minutes, drain the water and dry the plugs in a suspended (flowing) layer under vacuum in a stream of hot air that flows through a heater and sterilizing filters and is pumped out with a vacuum pump.

After drying, the lower hatch is opened and the plugs are poured into the substituted canisters on the trolley.

Example 2. In the autoclave, as in Example 1, plugs and water are loaded and a non-sterile silicone emulsion is introduced. They are mixed with compressed air for 30 minutes, heated with live steam to 120 ° C and kept for 30-45 minutes, drained and dried, as in example 1. Here, the siliconization is combined with sterilization.

Technical and economic efficiency of the invention is to improve the reliability of sterilization due to the intensification of heat transfer. In addition, the elasticity of the caps is improved when the siliconization is carried out after (or during) sterilization, their moisture is reduced, all sulfur compounds (thiuram, etc.) are removed from the AB caps, which is necessary when capping preparations with high pH, for example kanamycin.

After the introduction of the invention, at the Kurgan Combine Synthesis Consumption of Corks, the consumption of stoppers for 1000 bottles of finished products was reduced by 110 pcs., The section for preparing corks for sealing kanamycin, which was autoclaved before washing, was excluded.

Claims (1)

Invention Formula A method for sterilizing rubber products, mainly stoppers for sealing vials with hygroscopic or drugs that require long-term storage, including siliconization, sterilization, and substance with continuous mixing of products, characterized in that, in order to improve the quality of sterilization of products, siliconization is performed after sterilization, and mixing in the sterilization, siliconization and drying process is carried out in a fluidized bed, while drying is carried out under vacuum. Sources of information taken into account in the examination 1. Instructions for use of machines for washing, sterilization and drying, mod. WPS DJS-40, HofJiger c Karg, 1970.