Pharmaceutical Guidelines

  Ultra Violet Light Disinfection in Pharmaceuticals Ultra Violet light is used for disinfection of purified water, treated effluent and pass boxes. Ultra violet light disinfection is also used in LAF unit. Ultraviolet light is used as a disinfection agent in pharmaceuticals. Short wavelengths of ultraviolet light create a harmful effect on microorganisms by  destroying their nucleic acids and prevent the growth of the microbial cells. First of all ultraviolet light is used for water disinfection is the United States in 1916. Now a day it is widely used to disinfect the drinking water and  wastewater. This is a low cost and very effective disinfection process. Ultraviolet light is short wavelength light than visible light having electromagnetic radiations. At a specific wavelength of 2537⁰A or 256 nm is harmful  to microorganisms and destroys the DNA of microbial cells. Thymine base of DNA and RNA is reactive with the ultraviolet radiations and forms  dimers (T=...

  Validation of UV Light in Purified Water System UV light radiation is important to control the microbial contamination but it should be validated to assure the efficiency of UV Light in Purified Water System. Validation of effective working of UV light in purified water system aims to demonstrate that the UV light purification process when operated within set  limits, produces highly purified pharmaceutical water with a high degree of assertion. Validation of this method is necessary to get pharmaceutical   water with all necessary quality attributes. Validation also offers a framework to initiate full control over the procedure, which monitors efficiency, safety and ultimately the method outcomes. In the pharmaceutical industry the quality of water is important and the main concern. This is because purified water is a crucial ingredient in  various pharmaceutical preparations as well as to clean all the process equipment and thus a central role in pharmaceutical ...

Validation of the Effectiveness of UV Light in Water System Validation of effectiveness in water system is very important because it helps to produce water for manufacturing of pharmaceutical drugs. UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water  is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out. The major aim in doing this validation is to demonstrate that when the UV light purification process is being operated under the ideal and set  conditions, it produces water that is high in purity and also has a high degree of assurance. According to FDA - Food and Drug Administration, validation can be defined as established and documented evidence that provides high  assurance degree that a specific process under investigation produces a product that meets predetermined quality characteris...

  Types of Purified Water Systems in Pharmaceuticals Purified water is prepared with using different purification methods like ion exchange, reverse osmosis and distillation. These purification methods are discussed here. One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation in  many pharmaceutical procedures. Special care and attention must, therefore, be taken to ensure that the water used, meets the standard quality for  purified water. Water is purified to remove impurities and prevent microbes which might cause contamination of products. For water to be rendered purified, it is passed through different types of induatrial water purification systems including distillation, filtration, reverse  osmosis and ion exchange. However, other suitable procedures such as ultrafiltration can also be used. Purified water is used in pharmaceutical  applications such as preparation of...

  Sanitization of RO Membranes in Purified Water System Sanitization of RO Membranes using strong chemical can damage and it can be sanitized using hot water. The main ingredient in most of the pharmaceutical products used by people is water. Given the ever-increasing concerns about the ingredients used to make pharmaceutical products, it is important to ensure that the water used is stable and consistent. The Reverse Osmosis (RO) system is at the heart of the process of water purification. It uses semi-permeable polyamide membranes that provide  rejections of organic and ionic impurities that exceed 99%. The RO membranes pores are in real sense intersegmental spaces within the polymer molecules. The membranes are large enough to allow  permeation of water molecules but not big enough to allow hydrated chemical ions to pass through. Below is a look at how sanitization of membranes  in the purified water system is done.  Several factors affect the selectivity of...

  Reynolds Number and Its Significance in Purified Water System Reynolds number is an important factor for purified water distribution system and it helps to maintain the required flow to prevent the formation of biofilm. Purified water is commonly used in the pharmaceutical industry, science laboratories, laser cutting and automotive use. Purified water finds a  considerable amount of usage in the pharmaceutical industry in the form of raw material, component and solvent in the production of a number of  medications. But before the purified water can be used in medications as raw material, ingredient or as a solvent, it is to be ascertained that it meets the basic  defined levels of chemical and bacteria purity. The water has to be regularly tested and monitored to maintain the required level of microbiological  content. In considering the design requirements of a purified water system , a number of factors need to be taken into consideration. The Reynolds numb...

  Reverse Osmosis System Basics for Water Purification Reverse osmosis system basics used to prepare purified water in pharmaceuticals by water purification. Reverse osmosis is the best-known filtration method and it is widely used in pharmaceutical water systems . This process is used to remove the  particles including ions from the water. Reverse osmosis system contains a semi-permeable membrane that allows passing the water and rejects the  contaminants. In most of the reverse osmosis system, it cleans the membrane itself and the process is known as crossflow. Reverse osmosis is capable to remove  the salts, sugars, proteins, dyes, bacteria and other particles having the molecular weight greater than 250 daltons even viruses. Related: Removal of Pathogens from Water Systems The reverse osmosis process requires a force to pass the water through the membrane known as driving force. This force is applied in the form of  pressure with the help of pumps. Contamin...

  Re-validation of Purified Water System Purified water system is a critical system in pharmaceutical industry. Re-validation of water system is mandatory after any change in system to maintain the product  quality. Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals. Due to an  increase of micro-organisms in water during distribution, purification and storage; constant control of microbiological quality, inorganic and organic  impurities in water are critical. Most of the water used for pharmaceutical purposes may vary in grade but is usually an extract of either drinking or comparable grade water hence  water systems in the pharmaceutical industry must be constantly validated to ensure continuous production of high-quality water. Revalidation of purified water systems is an essential part of the validation process . It increases the smoothness of the process while ensuring...

  Remove Residual Chlorine before Microbial Analysis It is important to remove the residual chlorine from the water sample before the microbial analysis. Raw water is chlorinated by adding sodium hypochlorite (NaOCl) to make its concentration 2-4 ppm. Chlorination of water is done to remove the  microbial load from the water. It helps the water system to produce the purified water of specified microbial quality. Mechanism of Action: When sodium hypochlorite is dissolved in water, it produces hypochlorous acid and hypochlorite ion. These hypochlorite ions are known as “free  chlorine”. This free chlorine is responsible for the chlorination of the microbes in water. These ions are highly active and penetrate the cell wall via  lipids and destroy the enzymes in the cells. All the free chlorine is not consumed in the chlorination. This remaining chlorine is known as "residual chlorine" which can interfere with the microbial  analysis of the water. This may alter ...

  Preparation Process for Water for Injection (WFI) in Pharmaceuticals Water for injection is used in sterile manufacturing and its preparation and storage is a critical process. There are basically two types of water preparation in pharmaceuticals. Water for Injection (WFI) preparation process and purified water preparation  process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection (WFI) system in  pharmaceuticals has stricter bacterial control standards than USP standards for purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection (WFI) preparation process in pharmaceuticals must include  distillation or double pass reverse osmosis techniques. Dechlorination: This refers to the removal of chlorine from the water. There are several ways of dechlorination.This include injection of a reducing  ag...

Mixed Bed Ion Exchanger in Purified Water System Mixed bed ion exchanger has an important role in the purified water system. Article explains its importance and regeneration of the bed. Water is a key element for the pharmaceutical and healthcare industries. Pharmaceutical manufacturers are concerned with producing purified water  that meets defined standard quality to minimize any risk to patients' health or interfere with the manufacturing process. Water acts as an important  ingredient in many formulations and also as a cleaning agent. This makes the production of highly purified water and pyrogen -free for injection to very critical and should meet the international standards. The  most common and accepted method of purification is the use of mixed bed ion exchanger in the purified water systems for pharmaceuticals. A mixed bed ion exchanger in water purification uses two ion exchange regenerative systems formed in beads shape. It allows the cation and anions  ...

Importance of Cation Exchanger in Purified Water System Working and significance of the cation exchanger in purified water system during water purification. Water is widely used and an important raw material in the processing, formulation and production of pharmaceutical products and medical devices. Purified water has unique chemical properties making it ideal to absorb, dissolve or adsorb many different compounds. Having a purified water  system in pharmaceuticals is a great way to control the quality of water all through the production, storage and distribution processes . In pharmaceuticals, purified water is also necessary for washing laboratory instruments. Therefore, incorporating a cation exchanger in purified water  system ensures the purified water meet the stringent standards. The ions in water are exchanged for other ions that ensure purity. Raw water has suspended particles such as colloids, silt and pipework debris. It also has dissolved inorganic compounds th...

Importance and Method of De-gassing in Purified Water System Learn how is it important to de-gas the water treated with cation bed and the procedure of de-gassing using forced draft method. In pharmaceutical industries, bore-well is the principal source of the raw water . Raw water is purified by water purification systems to use in  pharmaceutical manufacturing. Cation and anion beds are used to remove the hardness of raw water. Degassers are used to remove the dissolved gases from the water. When water is passed through the cation exchange , carbonates and bicarbonate  ions are converted into the carbon dioxide (CO2). Carbon dioxide is soluble in water, therefore; it is not removed from the treated water. Related: Purified Water Storage and Distribution System This carbon dioxide increases the ionic load on the anion bed resulting in the more consumption of the sodium hydroxide. The efficiency of the anion  resin is also affected due to this dissolved carbon dioxide. D...

  How to Remove Pathogens from Water Systems The process to remove pathogens from the purified water system and water for injection system by sanitization. Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful to human. Those can survive into  the purified water as well as the water for injection . The pathogenic bacteria found in water system are E.coli, Salmonella and Pseudomanas. Generally, these are attached in the filtration membranes of water system such as Reverse Osmosis membranes and Ultra-filtration membranes or  sometimes a biofilm can be formed in pipelines of the water system. Sometimes when we analyze the purified water or water for injection (WFI) for the microbial limit test pathogens are found in the sample. In that  case, we should re-analyze the sample first to sure the occurrence the presence of pathogenic bacteria in the water system. Related: Types of Water in Pharmaceuticals When such...

Dead Leg and its Limit in Water Systems Dead leg calculation in water system piping and their limits according to world health organization (WHO). Water system in pharmaceuticals may the source of contamination for the manufactured products. It is necessary to prevent the water system  from microbial contamination . Water is distributed through the pipelines throughout the manufacturing plant. Purified water and water for injection (WFI) is continuously circulated in  the circulating loop. It helps the water system to prevent the formation of biofilms . But there is some space between the circulation loop and the valve at the user points. This section of stagnant water is known as Dead Leg. Related: Chemical Sanitization of RO Systems and Biofilm Removal  Long dead legs will have more stagnant water having more microbial growth because the water in the dead leg does not circulate with circulating  water. Therefore dead legs should be short. According to WHO: TRS 9...

  Chlorination and De-chlorination of Water System Effective concentration of chlorine and chlorination and de-chlorination of water system using Sodium hypochlorite and Sodium metabisulfite. Purified water is a basic requirement of any pharmaceutical industry. Generally, the source of raw water remains a bore well and raw water is stored  in a storage tank. This raw water is stored for several days. These storage tanks are not cleaned for many days. Due to this situation problem of  microbial growth would occur in raw water storage tank and can contaminate the whole water system . This is a common problem in pharmaceutical industries and generally solved by chlorination of the water storage tank. Sodium hypochlorite is used  for chlorination of water. When sodium hypochlorite is dissolved in water is gives free chlorine that forms hypochlorous acid which actively takes part  in disinfection process. Cl2 + H2O → HOCl + HCl Chlorine is a strong oxidizing agent ...

  Biofilm Removal and Chemical Sanitization of RO Systems Sanitization of the reverse osmosis water purification system and biofilm removal from water system. To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation, it is important to chemically clean the  first-pass RO system. This will help to disrupt any biofilm that protects viable bacteria from contact with the sanitant. It also removes foulants that will  react with and chemically deplete the sanitizing agent. Typically this is done in a two-step process. The first step commonly involves the use of an acid cleaner such as citric acid to remove the inorganic  foulants. Next, a high-pH cleaner such as sodium hydroxide is used in order to remove organic foulants. Then the system is sanitized with one of the following agents: formaldehyde, hydrogen peroxide, or peracetic acid/hydrogen peroxide. It is  important to consult the manufacturer of the RO system to...

Activated Carbon Filter and Increase in Efficiency for Water System Activated carbon filters are used for water purification in water systems and application of these filters can increase the efficiency of water system. The activated carbon filter is used to remove chlorine and organic matter from the water. It also removes the color and odor from the water hence the  turbidity of the water is also removed. It plays an important role in water purification systems where chlorine is added for decontamination. ACF is  unable to remove the microbes and hardness. Activated carbon filter contains carbon particles of various sizes ranging from 10 to 50 mesh. Activated carbon is prepared from coconut shells by  burning in the absence of oxygen generally in an atmosphere containing nitrogen or another inert gas. This carbon is then activated by steam or  chemical methods. In steam activation, this carbon is heated at 750- 950°C in the presence of steam. Steam activated carbon...

  5 Major Difference between RO and EDI Water Systems Reverse osmosis water purification systems (RO) and Electrodeionization (EDI) water system both are used in pharmaceuticals for water purification. Difference in both  water purification systems are described in this article. Water is the heart of the human body, 50-65 % on average, although when looking at infants the percentage is typically around 75-78%. Water intake  is mostly recommended since most body processes require it to facilitate optimal body functioning. Hard water contains much of dissolved minerals  and the process of water purification comes from understanding the difference between RO and EDI water filteration systems. 5 Major Difference between RO and EDI Water Systems Reverse Osmosis Water System 1. How RO Works RO system uses strong pressure gradient to drive water through the semi-permeable membrane while removing impurities, thus leaving water  purified. The system uses water line valve...