The latest development of butyl rubber stopper industry at home and abroad mainly includes the following aspects:
1. Study on ultra-clean rubber, special materials, formulation and technology.
These studies mainly ensure the quality requirements of some special sensitive drugs, such as some chemical and biological sensitive cephalosporin injection preparations, infusion preparations with strong acidity and alkalinity, and traditional Chinese medicine preparations with complex components. From the formula of butyl rubber stopper, raw rubber and some accessories belong to fat-soluble substances, which may also contain low molecular weight substances. If these substances remain more in the production process of rubber stopper, after encapsulation of drugs, they may enter into drugs and undergo biological adsorption, resulting in a decrease in solubility of water-soluble drugs, a decrease in clarity or even turbidity. Therefore, ultra-clean rubber and simple and clean vulcanization system are selected, stable and effective production equipment and process are adopted, so as to produce clean rubber plugs that meet more drug requirements.
2. Study on Coating, Coating or Coating Plug
A new isolation film is added to the surface of the rubber plug. In terms of technology, including film-coating, film-coating and film-coating, according to the classification of film-forming materials, there are mainly: PTFE film or ETFE film for local film-coating of rubber plug, PET polyester film for local film-coating of rubber plug; in terms of film-coating, fluorinated polymer and other plating layers formed by vacuum electroplating, vacuum deposition of poly-p-xylene film rubber. Plug; and the way of coating can be made by coating polydimethylsiloxane film.
For purposes, adding a barrier membrane can reduce the interaction between rubber plugs and sensitive drugs to achieve the best drug compatibility. However, barrier membranes are not 100%-ldquo; universal-rdquo; both coating and coating can reduce the migration of low molecular weight substances to drugs, and can reduce the diffusion of drugs adsorbed on the surface of bottle stoppers into bottle stoppers, but can not be completely eliminated.
The validity of the coating is determined by the true thickness of the film, the material and the bonding process between the film and the rubber plug matrix.
3. Low particulate silicone oil or silicone-free butyl rubber stopper.
Butyl rubber stopper is usually silicified by adding a certain amount of silicone oil before leaving the factory. However, many experiments have proved that the silicone oil on the rubber plug surface is a polar molecule, which is easily absorbed when it contacts with some cephalosporin powder, thus hindering the normal dissolution of the powder and generating turbidity. At the same time, silicone oil can easily cause particles exceeding the standard in rubber plug detection. Therefore, a new type of silicone oil is developed, and the siliconization process is optimized to make it firmly adhere to the surface of rubber plug, so as to improve the siliconization performance. In Japan or European and American countries, there are rubber plug factories that first Silicify the whole surface of vulcanized film, that is to say, use temperature or ultraviolet ray to solidify the suitable silicone fluorine material sprayed, so as to form a relatively solid silicone fluorine coating, so that silicone oil is not added when rubber plug is cleaned.
4. RFS sterile rubber plug.
RFS sterilized rubber stopper is registered by famous international rubber stopper company. At present, it generally refers to the packaging method that can be directly sterilized. This packaging enables the rubber stopper to be directly sterilized without any pretreatment and cleaning during the use of the pharmaceutical factory. RFS sterile packaging bags are usually made of high density polyethylene and Tyvek materials. Tyvek material has excellent water vapor permeability and become a packaging material for steam sterilization. RFS sterilization package is also suitable for ethylene oxide sterilization, but not for dry heat sterilization.
More importantly, the factory can develop RFS sterile rubber stopper technology, not only by using sterile bag packaging or steam sterilization technology, can achieve, the most important is the entire process design, production quality management, product quality stability, physical, chemical and biological indicators verification, to prove that rubber stopper is in line with the requirements of production and manufacturing process, in order to achieve customers. The household does not need to carry out the cleaning process again, but directly sterilizes the rubber plug.