The correct answer: Sterile water for Injection is Sterilized Pyrogens free water commonly used in Compounding of Parenteral products or small Lab. batches where no terminal sterilization is required.
Does sterile mean pyrogen-free?
Certainly, sterile does not mean pyrogen-free. While the term Pyrogen-free means the absence of pyrogen. Pyrogen is a group of substances that cause a rise in temperature in an animal body. Mainly pyrogens are two types: exogenous and endogenous pyrogens [3].
What is the best way to remove pyrogens from a product?
With respect to manufacturing equipment and transfer lines, depyrogenation by dilution has usually been the method of choice. Utilization of strong alkali or oxidizing solution has occasionally been employed to reduce pyrogens in these storage/delivery systems. However, it should be followed by rinsing with Water for Injection.
What are the sources of pyrogens in parenteral and medical devices?
There can be several sources of pyrogens in parenteral and medical device products. Usual sources are: the water used as the solvent or in the processing; packaging components; the chemicals, raw materials or equipment used in the preparation of the product.
What is sterile water for injection?
Hospira 50 mL Sterile Water for Injection is a sterile, single-dose packaged in a larger 50ml plastic vial. Sterile Water for injection is designed...
Is water for injection pyrogen free?
Water for Injection, USP; on the other hand is Pyrogens free water for use in large scale manufacturing, where the final product is terminal sterilized accordingly.
Is sterile water pyrogen free?
All sterile things are not pyrogen free. Pyrogens are endoroxins those require high temperature to denature.
What is pyrogen free water used for?
Endotoxin-free Water, Pyrogen-free Water Endotoxin-free water is required for mammalian cell cultures, as well as for the rinsing or the preparation of a solution or a device that will further be in contact with human and other mammals.
Can sterile water be used for injection?
Sterile water for injection vials are primarily used to reconstitute medications available as lyophilized powders. While the prescribing information for some medications may indicate alternative sterile liquids for reconstitution, most specify that SW for injection must be used.
What is the difference between water for injection and sterile water for injection?
Water for injection is water of extra high quality without significant contamination. A sterile version is used for making solutions that will be given by injection. Before such use other substances generally must be added to make the solution more or less isotonic.
How do you remove pyrogen from distilled water?
Ultrafiltration (UF) is an excellent way of removing pyrogen contamination from water. Ultrafilters (positively charged nylon 66 membranes) are recommended for the final “polishing” of water already treated by deionization (DI) or reverse osmosis RO.
How is water made pyrogen-free?
Preparing Pyrogen-free Water using Ultrafiltration To remove endotoxins, filters with a molecular weight from 5 KDa to 13 KDa are selected. Ultrafilters are positioned at the point-of-use, at the outlet of the water purification process. The water delivered is pyrogen-free and does not require autoclaving.
What is pyrogen water?
Water free of fever-producing proteins (bacteria and their metabolic products). See: water for injection.
What is an example of a pyrogen?
Good examples of pyrogen-producing gram-negative bacteria are Escherichia coli (E. Coli), Proteus, Pseudomonas, Enterobacter, and Klebsiella (Dixon, 2001).
Is sterile water free water?
There are two main reasons for these errors. First, healthcare practitioners may have a knowledge deficit about the risks of IV administration of sterile water. For example, prescribers are ordering sterile “free water” to treat hypernatremia. Free water refers to water not associated with organic or inorganic ions.
What is the difference between sterile water and distilled water?
Sterile water is water free from organic materials but is still not free from inorganic chemicals. Distilled water has some sterilization process but removes both organic and inorganic contaminants in the water. Thus, distilled water gives a pure form of water.
Is purified water sterile?
Put simply, purified water is water that's been mechanically filtered or processed to remove chemicals and impurities, according to Carpenter. The purification process removes contaminants including bacteria, chemicals, and toxins from tap water or ground water.
Description
Adinath offers Water for Injection Plant built with AISI SS 316L materials which produces pyrogen free sterile water (Water For Injection) which meets the requirement of Indian, British & United States Pharmacopoeia.
Salient Features of Water for Injection Plant
100% pyrogen free distilled water conforming to U.S.P./B.P. specifications.
Process Operation of Water for Injection Plant
Water-for-injection (WFI) is defined by the US Pharmacopeia as water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. WFI is intended for use in the preparation of parenteral solutions.
What is the difference between sterile and pyrogen free?
Summary of the difference between Sterile and Pyrogen-free. The term Sterile means the absence of viable microorganisms [1] [2]. The term Pyrogen-free means the absence of Pyrogen. A product is sterile that is confirmed by the sterility test.
What is depyrogenation in a filter?
Sterilization by filter. While depyrogenation is a process to make a product pyrogen-free. In other words, it is the process to eliminate pyrogens from the pharmaceutical preparations such as water for injection, SVP (Small Volume Parenteral), LVP (Large Volume Parenteral) as well as medical devices.
What does sterile mean?
Firstly, the term Sterile means the absence of viable microorganisms [1] [2]. Viable means the ability to proliferate through binary fission under precise conditions. In other words, viable microorganisms mean a cell able to live and multiply. Certainly, sterile does not mean pyrogen-free.
What is a pyrogen?
In other words, pyrogen is a fever-inducing agent produced by bacteria, molds, viruses, and yeasts [4]. Further, pyrogens are the metabolic product of microorganisms. In addition, chemically pyrogens are lipid substances associated with a carrier molecule, which is usually polysaccharide but may be peptide [1].
What is the process of sterilizing a product?
It is done by the following method [2]: 1. Physical Method. Dry heat sterilization.
Is sterile pyrogen free?
Certainly, sterile does not mean pyrogen-free. While the term Pyrogen-free means the absence of pyrogen. Pyrogen is a group of substances that cause a rise in temperature in an animal body. Mainly pyrogens are two types: exogenous and endogenous pyrogens [3]. In other words, pyrogen is a fever-inducing agent produced by bacteria, molds, viruses, ...
Is a sterile preparation a pyrogen free preparation?
However, in the pharmaceutical industry, some preparations may be sterile or sterile and pyrogen-free or pyrogen-free ...
What is a pyrogen?
"Microbial pyrogen" as opposed to "gram negative bacterial endotoxin" has become a general descriptive term for many different substances. However, pyrogenic substances can be produced by some gram positive bacteria, mycobacteria, fungi and also viruses, but the pyrogens produced by gram negative bacteria, i.e., the endotoxins, are of significance to the pharmaceutical industry.
How long does it take to depyrogenate glass?
Some texts have recommended the depyrogenation of glassware and equipment by heating at a temperature of 250 C for 45 minutes. It has been reported that 650 C for 1 minute or 180 C for 4 hours, likewise, will destroy pyrogens. Studies by Tsuji et al, published in 1978, have shown that at lower temperatures (of 170 C), thermal destruction follows second-order rate, and a 3 log reduction of endotoxin levels at lower temperatures might not be practical.
What is the endotoxin limit for sterile water?
Water for Injection, Sterile Water for Injection and Sterile Water for Irrigation have an allowable endotoxin limit of 0.25 Endotoxin Units (EU)/ml. (EU=Unit of measurement for endotoxin activity). However, Bacteriostatic Water for Injection and Sterile Water for Inhalation have been given a slightly higher bacterial endotoxin limit of 0.5 EU/ml (USP - Supplement 4a - 1984). The agency has recognized the benefits of the Bacterial Endotoxins Test, particularly with respect to sensitivity, reproducibility, scope and simplicity. Additionally, both FDA inspections and FDA testing programs have identified objectionable levels of endotoxin in drugs and devices.
How many EU/ml can be used for endotoxin testing?
This determined value means that if a parenteral drug manufacturer is using the LAL method for endotoxin testing of Cyanocobalamin Inj., the product can have no more than 350 EU/ml of product.
What happens if a drug is biologically produced?
Additionally, if the drug substance is biologically produced, the incomplete removal of the microorganism during purification can result in the drug substance having high endotoxin levels. Examples include antibiotics produced by fermentation or the by-products of gram negative bacteria used to produce genetically engineered drug products. The potential use of yeast in this area is being evaluated to eliminate this problem.
Can chromogenic methods be used with turbid products?
Turbidimetric and chromogenic methods cannot be used with certain turbid or colored products. Additionally, precipitate formation, although inhibitory, may be mistaken for a positive response in these methods. One problem associated with the use of the chromogenic method is the formation of a precipitate following the addition of acid to stop color development. Products that require a neutral or basic pH for solubility are most likely to cause this problem.
Is pyrogen an active substance?
For parenteral products, inspections have shown that where pyrogen problems were found in dosage forms, and when the source was one of the raw materials, it was the active drug substance. This was particularly true for drug substances in which process water was used at some late stage in the synthesis process. Endotoxin levels of the drug substance were subsequently lowered when the microbiological levels of the process water were lowered and the process water system was controlled.
Where is WFI water produced?
All WFI quality water produced in Logan, Utah, USA is tested to current USP monograph for sterile purified water. Water produced in Pasching, Australia is tested to EP monograph for sterilized water injections.
What is WFI water?
WFI is water that has extra high quality and lacks significant contaminants. Sterile WFI labeled specifically for parenteral use is used to make injectable solutions. Sterile water, including WFI in bulk packaging, is used in biomanufacturing processes. When it’s supplied in single-use containers of the appropriate size, the containers can be connected aseptically to other single-use components in the process to mitigate the risk of contamination.
What is WFI in bio?
WFI for use in biomanufacturing is prepared and tested according to the specifications in the monograph from the relevant pharmacopoeia – for instance, the United States or Pharmacopoeia (USP) or the European Pharmacopoeia (EP). Cytiva’s WFI water is purified by reverse osmosis/distillation water and meets requirements as per USP <71>.
What is WFI in cell culture?
Water for injection (WFI) is used to preparing powdered media and feeds for cell culture applications. With < 0.25 EU/mL endotoxins, our range of WFI products focuses on research and manufacturing processes to ensure consistent results.
What is USP sterile water?
Sterile Water for Injection, USP is sterile, nonpyrogenic, distilled water in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. No antimicrobial or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity O mOsmol/L (calc.).
What is USP water?
Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.
What is water for injection?
Water for Injection is a solvent used in the production of parenteral and other preparations where product endotoxin content must be controlled, and in other pharmaceutical applications Water For Injection (WFI) is sterile, non pyrogenic, distilled water for the preparation of products for parenteral use. It contains no added substance and meets all the requirements of the tests for purified water. It must meet the requirements of the pyrogen test. The finished water must meet all of the chemical requirements for Purified Water as well as an additional bacterial endotoxin specification. Since endotoxins are produced by the kinds of microorganisms that are prone to inhabit water, the equipment and procedures used by the system to purify, store, and distribute Water for Injection must be designed to minimize or prevent microbial contamination as well as remove incoming endotoxins from the starting water. Water for Injection systems must be validated to reliably and consistently produce and distribute this quality of water.
What is sterile water for inhalation?
Sterile water for Inhalation is Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions. It carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and therefore, is not suitable for parenteral applications.
What size container is used for sterility test?
It’s specifications are provided in USP monograph for water for injection, sterilized and packaged in suitable single-dose containers, preferably of type I glass, of not larger than 1000 ml size. It meets the requirements of the sterility test and pyrogen test and other tests under purified water.
What is the purpose of endotoxins in water?
Since endotoxins are produced by the kinds of microorganisms that are prone to inhabit water, the equipment and procedures used by the system to purify, store, and distribute Water for Injection must be designed to minimize or prevent microbial contamination as well as remove incoming endotoxins from the starting water.
How big is sterile water?
This is sterile Water for Injection containing bacteriostatic (antimicrobial) agents. It may be packed in single-dose containers of not larger than 5 ml size and in multiple-dose containers of not larger than 30 ml size, the label of which indicates the name and the proportion of added agent.
What is purified water?
Purified water: Purified water is used in the preparation of all medication containing water except ampoules, injections, some official external preparations such as liniments. Purified Water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination.
What is water used for in pharmaceuticals?
It is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents. It may present as an excipient, or used ...
What is the best way to obtain sterile solutions?
For some applications, sterilising filtration is acceptable (microfiltration through 0.22 μm filters) as a way of obtaining sterile solutions,in the case of WFI, distillation is the only accepted method. Industrially, WFI is obtained by means of condensing clean steam coming from a generator supplied with distilled water (DW). WFI is condensed and is generally kept at 80 - 90 ºC to maintain its properties.
How is pretreated water stored?
mostly consists of passing the pretreated water through the reverse osmosis modules. Before its storage, the treated water is passed through a UV lamp to
What is WFI water?
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative.
What is WFI in bulk?
2/ WFI (in Bulk I assume) is the Water for the preparation of medicines for parenteral administration when water is used as a vehicle. It contains no added substances
What is a sterile diluent?
It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral products. It may also be used for other applications where bulk Water for Injection or Purified Water is indicated but access to a validated water system is not practical, or where only a relatively small quantity is needed.
What is the difference between distilled water and water for injection?
The difference between the distilled water (DW) and water for injection (WFI) is mainly based on their physical, chemical and microbiological properties. A typical distilled water system consists of various stages, each one is designed for further purification of water. The first step is known. as "pretreatment" and the aim ...
Is USP water a pyrogen?
Water for Injection, USP; on the other hand is Pyrogens free water for use in large scale manufacturing, where the final product is terminal sterilized accordingly.
Definition of Sterile and Pyrogen-Free
Testing Method
- Secondly, sterility test confirms that a product is sterile. In fact, sterility tests are performed on products and materials subjected to a previously validated sterilization procedure. According to the United States Pharmacopeia (U.S.P) sterility test is done by two basic methods : 1. Direct inoculating the test sample on a suitable culture medium at optimum conditions for bacterial gr…
Method to Make Sterile and Pyrogen-Free
- Sterilization is a process to make a product sterile. In other words, it is a process of killing or removing bacteria and other forms of living microorganisms such as fungi, bacteria, and viruses and their spores. It is done by the following method : 1. Physical Method 1. Dry heat sterilization 2. Moist heat sterilization 3. Sterilization by radiations 2. Chemical method 1. Gaseous sterilizatio…
Finally, Example of Sterile and Pyrogen-Free
- Sterile products are most frequently solutions or suspensions but may even solid pellets for tissue implantation. Example of some sterile preparations is parenteral, ophthalmic and irrigating preparations. Example of some Pyrogen-free preparations is water for injection, SVP (Small Volume Parenteral) and LVP (Large Volume Parenteral). However, in t...
Image of The Difference Between Sterile and Pyrogen-Free
- References 1. Lechman, Lieberman, Kanig (1976). The theory and practice of industrial pharmacy (2ndEdition). Philadelphia, USA: Lea and Febiger 2. Ashok K. G. (1994). Introduction to Pharmaceutics-I (3rdEdition). New Delhi: S.K. Jain 3. Anochie, Philip Ifesinachi (2013). Mechanisms of fever in humans. International Journal of Microbiology and Immunology Resear…