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Advice You - Have You Selected Wrong Materials for Chemicals?
Chemicals are very much a part of our lifestyles. Every household detergent, solvent, and bleach that you use in your homes is a result of some production efforts from manufacturing plants somewhere in the world around you. Fertilizer, automobile radiator coolant, shampoo, soap, insecticide, paint solvent, lubricants, fuel oil are just a few that I can name rig According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product ht now. I’m sure you can find more around you, but you get the point. We use chemicals everywhere. Anyone who has visited a chemical processing plant is sure to notice the many pumps, agitators, tanks, piping, and valves that are installed there. Liquid have to be transferred from one place to another. Pumps are therefore very important in a chemical processin ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in g plant. Without them the chemical processing plant will literally come to a halt! One of the main jobs for Plant Engineers is to maintain the numerous pumps installed at their plant. These pumps can count into the hundreds or even thousands, depending on the size of the plant. So you should realize that to do a proper preventive maintenance, it is no mean tas lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. k. There must be regular schedules, proper tracking of jobs done, available manpower and skills, suitable tools, replacement parts, materials and a proper system of administration of all these. Sometimes, even with all the maintenance activities being carried out, pumps do fail. And when they do, plant engineers will have to find out what causes them to fail. here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe specially with new pumps where there is very little record trend of breakdown, engineers will be hard pressed into finding solutions for this. This is when experience helps in pinpointing the cause(s) of the failure. Pumps or other machinery will give tell-tale signs when they are not working properly. An observant pump user will be able to avoid major breakdo d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro wns or damage if the problem is corrected early. In order to solve any pump problem, we need to notice the symptoms carefully so as to determine the most likely causes. Instruments like pressure gauges are very helpful and should be installed in the pumping system. Very often we do have to rely on our 5 senses to determine the exact symptom. Normally, pump pr ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc oblems can be classified into: 1) Suction Related, 2) System Related, or 3) Mechanical Related. It can also be a combination of these. Most of the system related problems occur because of design flaw. For example, the designer may have chosen the wrong pump whose characteristic does not match the system requirement. Suction related problems are u easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi sually caused by air locks that are due to a variety of reasons. I will not mention them here. The effects of mechanical related problems could manifest themselves as suction related problems - air leaks in the system, worn out impellers, and mouth rings - but the most common symptom is the presence of vibration and abnormal noise in the equipment. However, t nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ere is one area where we seldom focus on - the effect of chemicals. Was the material selected able to withstand the chemicals? If you have done all your designing right and you still find that leaks are occurring so frequently, chances are that the materials are failing due to chemical reaction. Signs of corrosion at the seals are a strong indication of materia and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ l failure due to wrong usage. Nowadays, waste treatment plants or even process plants are called upon to process strong acids, alkalis, oxidizers, solvents, waste, slurry and other corrosive and abrasive chemicals. And it is not only pumps that are affected. Agitators, storage tanks, and piping need to be compatible to these chemicals. If the wrong material is ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi selected, it can lead to dangerous and widespread consequences of chemical spills, emergency evacuation, pollution, environmental damage and other disruptions to the production facility. Engineers in such chemical processing plants need to know what materials are suitable to be used for their process. It is much more complex than just selecting materials for ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a water pumps. Much detailed and careful selection choices based on the chemicals, the temperatures (because some of the plastic materials can weaken at temperatures that are considered normal for metals), chemical reactions, safety, spills and many others have to be taken. The aim of any maintenance personnel is to lengthen the lifespan of equipment under his c dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod re. Selection of chemical resistant materials is not a one-cure-fits-all solution. Some materials are not affected by certain chemicals but can be damaged by others. Some have good mechanical strength while others cannot last long without reinforcement. Usually, materials that can withstand many types of chemicals are very expensive. Cost considerations need t cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin o be taken into account when choosing a material for a certain application. If there is a choice of materials for a certain application, it makes better sense to choose cheaper materials if they can perform just as well. There are several components to check for when selecting suitable materials: 1) Elastomers for flexible parts like seal rings and gaskets tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen r>
2) Metal parts like shafting, springs, holders, bolts & nuts, and pressure gauges 3) Plastic parts like housing, piping, impellers, and covers Metals have good mechanical strength that can last very long in operation. In fact some parts need to be made of metal, e.g. bearing housing and shafts. Pump housing made of metal can be casted and machined ea t? As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel sily. They are able to withstand abrasive fluids and rough handling without any other reinforcement. One very important characteristic of metals is heat conduction. If the chemical to be pumped is hot, metal is always the choice. Plastics have become the better choice for many corrosive chemical applications because it is more resistant to chemical action than ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust metals. When using plastics to replace metals, you have to compromise on the mechanical strength of the pump. If the pump does not encounter much rough handling or abrasion, plastics can be used. Sometimes plastics are used to coat metal parts. These are fine as long as the plastic coating remains intact. Elastomers are the flexible materials that are needed f y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products or sealing the pump parts. There should not be any compromise here. Laboratory tests on the suitability of elastomers with certain chemicals should be followed. Unsuitable material used can cause leaks that can lead to other failures in other parts. With so many chemicals in use today, how do we know what materials can be used for what chemicals? Sometimes liq . As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de uids to be pumped contain chemicals that are both corrosive and abrasive. Should we choose a plastic or a metal housing? Sometimes chemicals may become hot either through the process or through mis-operation of the system - perhaps, somebody forgot to open a valve. Plastic parts can weaken at high temperatures. It's only through the result of test and actual o elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip peration that we are able to know what materials to use. It is good to know what to expect when we make a decision for a choice of materials to use. A good choice may involve some compromise. To help you make a good decision, check out for a list of Chemical Resistance Data of Materials tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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