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Overall, comprehensive consideration and attention should be made to the situation in which dust is generated in the production equipment of pharmaceutical products. The reason for the generation of dust in the production of pharmaceutical products can be attributed to two: the formation of wear-resistant particles and particles precipitated from the gas. For example, a gas containing particulates can be precipitated by a lubricating fluid and concentrated and precipitated during the production of the drug. The optimized lubrication medium management can effectively suppress the generation of lubricating medium gas particles during the production of the drug.
Lubricating media used in clean room conditions must first meet the following basic performance requirements: good lubricity, high wear protection, long service life, long lubrication medium addition period and good compatibility of plastic materials. Insufficient lubrication or faulty lubricants can result in high coefficients of friction or rapid wear of parts. In principle, these are things that people don't want to see, and in the clean room conditions, it will bring even worse results, such as tiny abrasive particles floating around in the clean room, resulting in ultra clean Room air pollution. By selecting a suitable, good-performance lubricating medium, the wear of the friction pair can be reduced, and the wear particles that float around can be significantly reduced.
The perfluorocarbon-based lubricating medium polyether polymer lubricant and PTFE are very suitable for use as a lubricating medium in clean room conditions. At the same time, they also provide good wear protection, especially in the friction pair of a pair of plastic materials, because they have good compatibility with plastics. In addition, they have good compatibility with the common methods of sanitizing in clean rooms, such as steam at 121 ° C, disinfection with hydrogen peroxide solution, ozone sterilization and ultraviolet radiation.
Quietly accept the test <br> <br> judge whether a lubricating medium suitable for an important criterion used in the clean room is as low as possible precipitation coefficient. In the ultra-clean room rating, although the precipitation performance of the lubricating medium is not specified, the sediment is regulated. Klüber Lubrication has succeeded in the development of Barrierta, which has a very low gas evolution coefficient even at very high temperatures.
A test developed by the Hofer Hof Institute of Process Technology and Automation in Frankfurt also confirmed that there is very little gas evolution in this lubricating medium. This industrial analysis of organic components, Purge and Trap-DT-GC/MS, combines chromatographic techniques with mass spectrometry to make it ideal for the analysis of gaseous raw materials.
A special decontaminated base oil is used in the production of Barrierta L55 lubricants, which are specially produced for Klüber Lubrication. This lubricant has a long service life in most environments where conventional corrosive media are affected, such as in conventional acid and alkaline environments, in conventional organic and organic gas environments. For some important plastic friction pairs, this lubricant also provides excellent wear protection. Among its important strengths are the excellent lubrication of bearings and guide rails in high temperature environments. Its low volatility allows it to have a long lubricant life and cycle of addition. This lubricant has a wide range of applications in the life sciences, such as injection filling equipment, insulin production equipment.
Reduce maintenance workload
When selecting a lubricant material suitable for use in a clean room environment, not only the special clean room working environment and conditions of use, but also other hygienic regulations for pharmaceutical products must be considered when selecting a lubricant, such as The GMP pharmaceutical production quality specifications shall be recorded in order to record the auxiliary materials required for production. For lubricating materials, it is mainly to implement the NSFH1 registration system and the ISO21469 certification system. They provide the certificates required to meet the quality management of GMP pharmaceutical production.
As a manufacturer of lubricating materials, it is of course necessary to provide users with more comprehensive support and assistance, for example, to provide a method for determining the amount of lubrication required for a specific friction pair, because the use of excessive lubricating medium is also harmful to insufficient lubrication. (Excessive use of lubricants increases the contamination of precipitated particles). Also beneficial to the user is the precautions for proper lubrication provided by the lubricant manufacturer, such as accurately performing lubrication at the point of friction.
In some important applications, such as in the production environment of clean rooms and in the production environment of pharmaceutical products, manufacturers can get more from the experienced lubricant supplier, not only the economic gain, It also includes the guarantee of production reliability.
Which standards relate to lubricants?
The international standard ISO21469:2006, which became effective in 2006, is safe for machine tools: the unanticipated hygiene requirements for lubricants in contact with the product. The publication and implementation of this standard is an important step in the standardization process in the production of food and pharmaceutical products. This standard is a step further than the original standard: it covers the entire process from formulation development to production. At the end of 2007, NSF provided a set of certification methods that conform to the ISO21469 standard. This certification method includes verification of sanitation and disinfection measures in an independent, external production process, including formulation inspection and label inspection, on-site review, risk assessment, and product testing.
An NSFISO21469 certification can be used as a proof that the lubricating material meets the requirements of the GMP pharmaceutical production quality specifications of pharmaceutical manufacturers, and has a complementary effect on the current H1 technical specifications.
Introduction to management of lubricating media in clean rooms
In the production of medical products, bearings, transmissions, guide rails, and other mechanical and mechatronic components are produced in the production process under ultra-clean room conditions, and have components suitable for working under friction load. The lubricating medium used here must meet special clean room conditions and must be able to reduce the contamination of the lubricating medium.