Pharmaceutical Guidelines

A Different Approach to Validation and Re-validation of Washing Machine and a Depyrogenation Tunnel Learn a different approach to validate the washing machine and depyrogenation tunnel. Introduction The current economic situation has determined in the pharmaceutical field an increase of cost control necessity. This situation, joined with the difficulty of developing new molecules with both traditional streets with the latest generation (R&D outsourcing, biotechnologies) is putting under pressure all those activities that apparently does not lead to a gain, but rather, but are the cost for the company, like equipment validation and/or revalidation. This pressure, if not properly channeled, can lead to the belief that these activities are ends in themselves and generate only paper without any real benefit to the company in terms of knowledge of the process (knowledge in its broadest sense and not just in the act of production but also, of all that is ancillary to it and placing on ...

  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...