Brief on Pure steam generator validation
Pure steam generator validation is a documented proof of the stability and uniformity of a steam generator process or system. Validation is the act of proving and documenting a process or method that leads to expected outcomes. There are some documentations associated with validation. These are specifications, standard operating procedures, validation master plans, protocols and reports. There are other important factors associated with validation such as time, finance and human experience.
Pure steam generator validation process goes through the following tests such as pure steam sampling test, analysis of steam, steam dryness test, pH test, conductivity test, microbial test and endotoxin test. Bacterial endotoxin test and chemical test have to be done separately. Gloves should be worn before sampling the pure steam.
Let us discuss these tests and protocols in detail.
Non condensable gasses such as air and carbon dioxide do not condense with the steam. These components enter the steam during filtration process and should be limited to 4 percent during steam conversion. Dry steam is the steam that contains less amount of water in it as compared to wet steam. Dry steam has more energy than the wet steam. The amount of water should not be more than 10 percent in the dry steam because if the amount of moisture is high then the sterilization process will get lengthy. The pH of the water should be somewhere between 5 to 7 and the conductivity of water should not be more than 1.2 micro siemens per centimeter. Conductivity should be tested when the water is at 20 degree Celsius. There should not be any microbial contamination present in the steam.
Protocols should be easy to understand, should be written in simple language, training should be provided to workers and the protocol should be written by a qualified person.
Water system in pharmaceutical industry
One of the most important components in the pharmaceutical industry is water and Water systems in pharma industry is essential for the continuous running of the pharmaceutical procedures. Great care is taken towards water purification so that the water is free of impurities and microbes before it is taken for further processing.
There are various processes used in water treatment systems such as ion exchange, reverse osmosis and distillation.
In the ion-exchange process, the undesirable ions are exchanged with the desirable ions and later the unwanted brine is flushed out. Ion exchange process requires minimum maintenance and hence it is one of the most favoured methods of water purification in the pharmaceutical industry.
In the reverse osmosis process, the pressure is applied to the concentrated solution in an osmosis process due to which the water starts flowing from a more concentrated solution to a less concentrated solution. RO systems are not that efficient for the cleansing process of bacteria and thus needs regular maintenance.
In distillation systems, the water is heated to high temperature and after a certain time, the water vapour is recovered using condensation method.
Impure water can cause contamination of pharmaceutical products and thus it has to be purified by using water treatment systems before passing it through pharmaceutical processes. There are various types of water purification systems such as distillation, reverse osmosis, filtration, and ion exchange. Clean water is required for pharmaceutical operations such as cleaning of specific pharma instruments, manufacturing of pharmaceutical products, sanitization, formulation and rinsing.
There are other features and benefits of Water systems in pharma industries such as reduction of overall water consumption and energy consumption through recycling, validation and support cleanroom factory acceptance test facilities, full or partial subitizable heat systems, skid mounted technology etc.
Water system designs lower the cost of operation and ensure long term operating systems. There are many types of water systems in the pharma industry but here we will look into two types. These are Water treatment systems and Purified Water Distribution system.
The features and benefits of purified water distribution systems are closed-loop recirculation system, auto sanitization and auto sterilization system, pumps working at optimum peak loads, documentation and support system, orbital welding with boroscopy and videoscopy etc.
Water is a highly valuable component in the pharmaceutical industry and its purification and distribution process is one of the most concerned and complicated processes.
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Brief detail about CIP System
CIP System is used for the cleaning of the interior surfaces of the vessels, pipes, fittings, filters and other equipment without dismantling the machinery. CIP is used in various industries such as dairy, beverage, pharmaceuticals, brewing, cosmetics etc. There are many advantages of CIP such as less labor, fast cleaning, repeatable processing and less chemical exposure.
There are various factors that affect the performance of CIP System like Temperature, Contact time, pressure and concentration.
Increasing the temperature increases dirt removal efficiency. High kinetic energy molecules wash the dirt faster and efficiently compared to cold slow molecules. Detergents are used in CIP and longer the detergent contact period, higher is the cleaning efficiency. The concentration of the cleaning solution has to be monitored because a highly concentrated cleaning solution will wash the dirty surface much efficiently than a dilute solution.
There are many designs of CIP Systems such as single tank, multi-tank, portable tank, two tanks, once through tank etc. These tanks are bought from the industry depending on the cleaning standards. CIP machine is a good choice because it reduces the usage of chemicals, cycle time, reduces water costs and encourages worker safety.
Although the plant looks clean from the outside still bacteria which are invisible to the eye can defile the substances or food inside the container causing a foul smell. For this reason, it is usually recommended to use CIP Systems inside the plant to maintain hygiene.
There are two types of CIP cleaning methods. They are high-pressure cleaning and low-pressure cleaning respectively. In high-pressure cleaning, dirt is removed by force and in low-pressure cleaning chemicals are used to remove the stubborn dirt particles.
Various cleaning agents are used for cleaning the equipment such as Caustic soda, phosphoric and nitric acids, per acetic acid and sodium hypochlorite. Caustic soda is used for the cleaning of fats and dirt and but it doesn’t remove the tough scales. It is mainly used for removing soils from tanks.
Hypochlorite is used for disinfecting operations and if not monitored correctly then it can react with stainless steel and acids to form a dangerous chemical.
Phosphoric and nitric acids are used for removing debris and tough scales in plants. These acids can affect the pumps and the valves of the tank and hence should be handled with care.
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Brief on Pure steam generator validation
Pure steam is used very commonly in sterile pharmaceutical manufacturing processes. It is used in sterilization techniques among many other operations in pharmaceuticals. A pure steam system should be designed as per cGMP requirements. During pure steam generator validation of a water system, samples should be taken from each steam user point and analyzed for impurities.
A pure steam generator validation needs the samples of steam need to be collected in dehydrogenated tubes or bottles and should be tested for the following –
- Non-condensable gases - Non-condensable gases are those that do not condense with the steam. They are generated from the gases that are continuously running in the pure water system.
- PH - Pure steam is tested for its pH levels. It shows the general acidic levels of the steam. At 25 degrees Celsius, it should be between 5-7.
- Endotoxin test - Steam used in the sterilization process should be free of endotoxins and other bacterial impurities. It should not be more than 0.25 EU/ml of water for injection (WFI)
What is CIP system & its advantages?
Pure water systems are an essential part of any pharmaceutical production process. The water used for manufacturing pharmaceutical drugs and medical devices needs to be of the highest purity. As such, water purification becomes an important part of the entire process and impacts the quality of the end product as well. Therefore, maintaining the health of the system is also important. Proper timely maintenance needs to be conducted on the systems and equipment. Modern processes equip their systems with a CIP system.
A CIP system helps to internally clean the process equipment like pipes, vessels, filter, and tanks used in the production of high pure water. There are a number of advantages of using a CIP system in your pure water system.
- A CIP system cleans your process equipment internally without the need to disassemble it.
- This minimizes the quality impacts due to human errors
- The need to not disassemble gives more production time and hinders less and less productivity.
Brief on Purified water system
Choosing a purified water system for a pharmaceutical manufacturing plant is no easy task. Manufacturers need to ensure that the water system is upto the quality standard requirements. They also need to make sure that the water system is as per their requirements in terms of production and productivity. When choosing a purified water system, their top concern is total organic contamination or TOC.
TOC testing a key part of testing of the efficacy of any purified water system. The United States Pharmacopeia or the USP sets the standards for pure water systems used in pharmaceutical manufacturing industries. However, there are some design flaws that manufacturers fall into and this eventually impacts the quality of water generated from the pure water plant. The most common mistake is using non-passivated stainless steel for piping systems.
As important as it is to design and manufacture the best water purification system, it is important to use the right materials for storage and distribution systems. Defects in the piping systems can cause contaminants to enter the water system.
What is Process equipment & its types
A process equipment is any equipment that is essential to the smooth functioning of the process. It includes pumps, vessels, tanks, filters, heat exchangers, valves and even piping. These process equipment have a variety of industrial applications like pure water generation, steam power generation, salt water disposal etc. We take a look at some types of process equipment below –
- Pumps serve the essential function of moving different types of fluids like water, chemical, petroleum, oil, wastewater or even gas. Their main application is in the boiler feed water, and are used for storage and distribution systems.
- Vessels and tanks - A vessel is a container that can handle pressure while a tank is simply a container that holds fluid at low or no pressure. Before designing a vessel or tank, it is very important to consider the application, the nature of the fluid to be used in it, its temperature, volume or capacity. It is vital that your vessel or tank is designed and manufactured as per cGMP or ASME regulations to avoid a negative impact on the entire production process.
