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Your clients are putting their trust in you when you manufacture pharmaceutical products that they will employ to enhance their health. They have faith that you have adhered to the strict hygienic requirements set forth by the pharmaceutical sector. You cannot, under any circumstances, compromise on sterility when producing vaccines, biological pharmaceuticals, injectables, oral solid doses, or other pharmaceutical preparations for the benefit of your customers’ health. This means keeping your facility’s equipment maintained in accordance with cGMP regulations. These standards still apply to the system of pure steam generator pharmaceutical in addition to the fact that your process must be error-free in and of itself, the pure steam you produce is a crucial component in the sterilization of all other systems.
What exactly is pure steam?
Pharmaceutical production facilities use a variety of steam types. Plant steam is used to heat systems; it is not in contact with sterile pharmaceutical formulations or the machinery used to prepare them. Process steam is made from pre-treated water without the addition of corrosion inhibitors. It is used in many different pharmaceutical facilities, but not in circumstances when the maximum level of sterility is necessary.
Distilling purified water without additives yields pure steam. Clean steam generation systems should satisfy the same standards as WFI generation systems with regard to endotoxin levels, conductivity, and total organic carbon. To be more precise, steam is only deemed pure if it meets the recommended endotoxin level of fewer than 0.25Eu/ml.
Selecting the Right Equipment for Pure Steam Generation
Selecting the pure steam generation system for your needs involves below criteria:
Production Scale
The kind of pharmaceutical product you are making and the size of your business will determine the pure steam generator you select. Flow rates and the needs for heat transmission through heat exchangers, pre-heaters, and double tube sheeting varied amongst activities. Invest in the right machinery if you are positive about the flow rates, products, and scales you will be working with in the future years. If not, there are always very flexible pure steam generators available, which let you change production capacity by up to 80% without requiring extra plant adjustments.
Design
Even when it’s there in front of your eyes, it might be challenging to recognize intelligent design. Fewer possible moving parts reduce the requirement for ongoing maintenance and unplanned downtime. Minimal internal components: It can be difficult to check, repair, and maintain the inside of your machinery. Video borescopes can be helpful in navigating this maze of internal parts, but steer clear of machinery that has an excessive number of intricate internal workings.
Construction Material
High temperature and pressure conditions are used to generate and distribute pure steam through machinery and process pipes. Of course, not every material is resistant to these harsh circumstances. Certain materials might corrode, while others might not be able to withstand the pressure applied to them mechanically. Therefore, the best material to use for building clean steam generation is one that is robust and resistant to corrosion. The importance of construction materials cannot be ignored in selecting the right equipment.
Quality Assurance
Even if you might not be familiar with every best practice involved in creating high-quality pure steam generating systems, that is the purpose of globally recognized recommendations. Make sure the equipment you choose conforms with the cGMP guidelines provided by regulatory agencies such as the ASME or the US FDA. Examining validation paperwork and testing the produced clean steam for conductivity, saturation, non-condensable gasses, endotoxin and microbiological contamination will help you determine this.