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In which areas of the pharmaceutical industry is compressed air used?

2022-08-17View Original

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In pharmaceutical production, strict hygiene standards apply to the production conditions, especially in clean rooms. Production must take place in an environment free from bacteria, particles, water, and contaminated oil. Therefore, high requirements are also placed on compressed air, as it often comes into direct contact with the products themselves during manufacturing in the pharmaceutical industry; for example, depending on its use, compressed air must be sterile or oil-free. To fulfill the obligation to provide evidence, such as supplying evidence to auditors, it is necessary to have continuous monitoring (24/7) of compressed air by coming into contact with the product. Although the pharmaceutical industry has established many regulations, such as IGMP, FDA, and the European Pharmacopoeia, these regulations do not define any compression air quality grades for specific applications. Compressed air being used as breathing air is an exception. Therefore, each pharmaceutical company must determine, in accordance with DIN ISO 8573-1, what quality of compressed air is required in the production process. Different processes in the pharmaceutical industry have varying requirements for compressed air. Tablet compression: Compressed air is required in the tablet manufacturing process, and this compressed air comes into direct contact with the product. This direct product contact occurs after the tablet press, namely using compressed air to remove dust particles or defective products. Oil-free and dry air is important under such operating conditions; otherwise, it can cause things like the tablets being compressed to expand. Compressed air can also be used to apply lubricant to the tablet press, making it easier for the tablets to pop out. However, compressed air has already been used in mixing powder mixtures or producing pellets for presses. Compressed air is also used in the pressing step, namely the so-called coating, that is, coating or encapsulation. The common process is the fluidized bed process, in which the airflow ensures that the tablets float and remain in motion. Spray them using a nozzle to achieve even wetting and drying. Compressed air is used as atomizing air here as well as in other processes, and is then considered a processing aid ; Therefore, high requirements are placed on its purity. In addition to the health risks for end-users, typical problems in tablet production also include foaming, tablet cracking, and color variations. Moist and oily compressed air may be a cause. Not only do the machines need to be cleaned, but the vials filled with medication, as well as ampoules and bottles, also require special cleaning. Compressed air is used for drying here. Another cleaning method is dry ice blasting. Dry ice impacts the surface to be cleaned and removes deposits. The separated sediment is then blown away with compressed air. During the production process, the filter must be cleaned in the fluidized bed system. This can be accomplished by a blowout filter system. Use compressed air to return the accumulated material back into the process. Here, there is also direct product contact, which leads to high requirements for the quality of compressed air. Another application is cleaning small bottles, flasks, and stoppered bottles: compressed air is also used here to dry the containers and remove any remaining particles. This usually happens in clean rooms. Pneumatic conveying: Compressed air is also frequently used in the pharmaceutical industry to transport components during the manufacturing process, such as bulk goods, liquids, powders, and particles. Pneumatic conveying can be carried out using compressed air or under vacuum. When conveyed under pressure, compressed air is generated and sent into the mixing head. For example, it picks up powder there and transports it to the desired location. Through this pneumatic conveying, the material being conveyed comes into direct contact with compressed air. This method is used to empty silo trucks and distribute materials in production. Finished products such as tablets and capsules are also transported back and forth between various processing units using compressed air. Transporting with compressed air can prevent damage to medicines, but this requires a constant supply of compressed air. According to DIN ISO 8573-1, VDMA recommends using compressed air with a sterile mass ratio of 1:3:1 for transporting raw materials and finished products. Pharmaceutical packaging: Compressed air is used in packaging systems, for example, for the transportation of products and packaging, or for sealing products and their packaging. For highly hygroscopic (water-absorbing) products, such as B. pharmaceuticals, a controlled atmosphere is created around the product. Especially when packaging medicines, it is necessary to provide very dry compressed air at the packaging point itself (such as inflation bags). There is usually a central compressed air production system, so compressed air still has to be delivered to the point of use. In this way, compressed air will fill the water again. Hygroscopic substances react with the moisture in the surrounding air. To ensure product quality, contact between humidity and the product must be avoided. Therefore, additional compressed air drying is required directly on the packaging machine. If the active ingredient is placed in ampoules and injection vials and then sealed, a sterile environment is even required. Control valves and cylinders: Compressed air is used as a control medium in the pharmaceutical industry, for example to regulate production systems through control valves and cylinders. Generally, lower requirements apply to control air, as it does not come into direct contact with the product. However, there are exceptions: the controlled air in clean rooms has special requirements. These also apply if controlling the air might affect the process. If the compressed air does not meet the requirements, it can cause failures in pneumatic tools and machines, corrosion in pipes, cylinders, and other components, as well as freezing in exposed pipelines in cold weather. This could increase downtime as well as the maintenance costs for pneumatic machinery, tools, and control devices. Therefore, proper preparation of compressed air, as well as regular inspection and maintenance, must be carried out here. In the pharmaceutical industry, there are many situations where oil-free compressed air is required. The way to obtain oil-free compressed air is not limited to using oil-free compressors at the source; it is also possible to use reliable catalytic oxidation-based oil removal equipment at a later stage to produce oil-free compressed air. This approach is particularly suitable for renovation projects in pharmaceutical factories.

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