Water for injections in bulk is obtained from water thatcomplies with the regulations on water intended for humanconsumption laid down by the competent authority orfrom purified water by distillation in an apparatus of whichthe parts in contact with the water are of neutral glass,quartz or suitable metal and which is fitted with an effectivedevice to prevent the entrainment of droplets. The correctmaintenance of the apparatus is essential. The first portionof the distillate obtained when the apparatus begins tofunction is discarded and the distillate is collected.During production and subsequent storage, appropriatemeasures are taken to ensure that the total viable aerobiccount is adequately controlled and monitored. Appropriatealert and action limits are set so as to detect adverse trends.Under normal conditions, an appropriate action limit is atotal viable aerobic count (2.6.12) of 10 micro-organismsper 100 ml when determined by membrane filtration, usingagar medium S, using at least 200 ml of water for injectionsin bulk and incubating at 30-35 °C for 5 days. For asepticprocessing, stricter alert limits may need to be applied.
Full Answer
What is USP grade water for injection?
ILS’s Water for Injection (WFI) USP grade is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. It complies with the USP monograph for water for injection packaged in bulk for commercial use.. Manufactured under cGMP and ISO 13485 guidelines in an FDA registered facility.
What is sterile water for injection?
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.
What is WFI grade water for injection?
ILS’s Water for Injection (WFI) USP grade is a terminally distilled, sterile, non-pyrogenic preparation which contains no bacteriostat, antimicrobial agent or added buffer. It complies with the USP monograph for water for injection packaged in bulk for commercial use..
What is the difference between sterilized water and bulk water for injection?
– Water for Injection in bulk: “Water for the preparation of medicines for parenteral administration when water is used as a vehicle”; – Sterilized Water for Injection: ” (Water) for dissolving or diluting substances or preparations for parenteral administration before use”. Source: EMA/CHMP/CVMP/QWP/496873/2018. Release: 13 November 2018.
What water can be used for injection?
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).
What is USP water for injection WFI?
Water for injection (WFI). WFI is most often used as an excipient in the production of sterile products and other preparations when endotoxin content must be controlled. Examples are pharmaceutical applications such as cleaning of certain equipment and sterile product-contact components.
How do you make water for injection?
Water For Injection System (WFI) can be created through distillation and through further purification by Reversed Osmosis. The more common method is through distillation, which is an intrinsically safe method. If a distiller would fail or produce insufficient heat, there is no evaporation and no WFI generation.
How do you make sterile water for injections?
Put the container in a pan of boiling water for 10 minutes. or Clean the container in a dishwasher on the full cycle (not a short wash). Put the mixture in a sterile container, write the date on a label, and put the sterile saline in the refrigerator.
What is bulk Monographed water?
“…the monographed bulk and sterile waters have a statement indicating that there are no added substances, or no added antimicrobial agents. In the case of antimicrobial agents, the purpose is to ensure that the sterile water product is rendered sterile based solely on its preparation, packaging, and storage.”
What is the PH of WFI water?
Between 5.0 and 7.0Specification for Water for Injection (WFI) as per USPSr.No.TestAcceptance criteria7pHBetween 5.0 and 7.08AmmoniumLess than 0.2 ppm9Calcium and magnesiumA pure blue colour is produced10Heavy metalsLess than 0.1 ppm.17 more rows
Why do doctors use distilled water for injection?
Because distilled water is so pure, it is a common tool used in the medical field. Hospitals use distilled water to prepare food for their patients and sterilize materials. Surgeons use distilled water during medical procedures.
Is water for injection the same as distilled water?
Water for injection is basically sterile, nonpyrgenic and with absence of particles. Sterile distilled water may contain pyrogens and other nonviable particles that may be harmful while administration i.v.
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.
Is boiled water sterile?
Boiling water kills or inactivates viruses, bacteria, protozoa and other pathogens by using heat to damage structural components and disrupt essential life processes (e.g. denature proteins). Boiling is not sterilization and is more accurately characterized as pasteurization.
Can you use boiled water for injection?
You can also buy them online. Boiled then cooled water is the next best thing. Use the water as soon as it has cooled: water that has been in the kettle for a while is more likely to contain bacteria.
How long do you boil water to make it sterile?
CDC recommends making water microbiologically safe to drink by bringing it to a rolling boil for one (1) minute.
What is WFI quality water?
Our WFI-Quality Water is aseptically processed from a validated Water For Injection System that meets current USP and
Can you request specific suppliers for critical raw materials?
For critical raw materials you can either request specific suppliers or rely upon our established global network of qualified
What is Gibco water for injection?
Gibco® Water for Injection (WFI) for Cell Culture meets the USP monograph for Water for Injection packaged in bulk for commercial use elsewhere. The water is prepared by distillation and filtration (0.1 µm), with no added substances. We monitor the water quality on a routine basis. Conductivity, total organic carbon, endotoxin and bioburden are tested daily; metals are tested monthly.
What is Gibco water for cell culture?
Gibco® Water for Injection (WFI) for Cell Culture is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. Available in many sizes to meet your needs, Gibco® Water for Injection (WFI) for Cell Culture features:
Is Gibco water bottled?
The performance and consistency expected from Gibco® liquid media products depends on the high-quality water we use in manufacturing. This water is also bottled as Gibco® Water for Injection (WFI) for Cell Culture. In addition to meeting USP standards, each lot is quality tested for sterility, endotoxin, conductivity, pH, osmolality, and oxidizable substances.
What is the main way to produce water for injection?
Distillation is the main way to produce Water for Injection. There are two basic technologies that have marked the history of the pharmaceutical industry for WFI production: the Vapor Compression (VC) distillation system, by vapor compression stills, and the Multiple Effect (ME) distillation system, by multi stage stills.
What is sterile water for injection?
Sterile Water for Injection, as defined by USP. It is WFI packaged and rendered sterile; it is used in applications requiring Water for Injection, where access to a validated WFI System is not serviceable (small q.ty needed, for example).
What is WFI in pharmaceuticals?
Therefore, International pharmacopoeias (USP, EP, JP) define as Water For Injection (WFI) only the compendial water used as an excipient to parenteral solutions.
What is purified water?
monographs. Purified Water is classified for pharmaceutical use as an excipient in the production of non-parenteral preparations and, in specific, for pharmaceutical preparations/tests and assays, for which water is indicated, unless otherwise specified (see related USP, ...
What is the minimal source of feed water for WFI?
Consequently, deionized water (that may be pre-treated for subsequent distillation or appropriate process) is the minimal source of feed water to produce WFI. In addition to the PW specifications, WFI adds the test for Bacterial endotoxins and complies with all requirements (except for Labeling) for the packaged water know as “Sterile Purified Water” (see USP monograph).
What is hemodialysis water made of?
for example in the diluition of concentrate solutions. It’s made from EPA (US Environmental Protection Agency) drinking water which has been further purified to reduce chemical and microbiological components. Note that WFH is not intended for injection.
Is WFI water sterilized?
Note: Purified Water (PW) or Water For Injection (WFI) that are packaged must be sterilized to preserve their microbiological properties; so we have other packaged monographed waters, as Sterile purified water, Sterile water for injection, Bacteriostatic water for injection, and so on (see related USP monographs).
What is sterile water for injection?
Sterile Water for Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection, USP.
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.).
How to remove a slit in a sterilization container?
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly, if leaks are found, discard solution as sterility may be impaired.
What is a Viaflex container?
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
What temperature should a pharmaceutical product be stored at?
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).
How much aluminum is in a drug?
Drug product contains no more than 25 µg/L of aluminum.
Do you need to inspect parenteral solution?
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.
How to order chemicals from VWR?
To order chemicals, medical devices, or other restricted products please provide ID that includes your business name & shipping address via email [email protected] or fax 484.881.5997 referenc ing your VWR account number. Acceptable forms of ID are:
What is ILS water?
ILS water is an excellent choice for upstream and downstream media/buffer preparation in biopharmaceutical manufacturing applications. It is also widely used in medical device manufacturing/processing applications where a high quality, sterile water is required
How to contact VWR customer service?
If you need further assistance, please call VWR Customer Service at 1-800-932-5000.
What is sterile water for injection?
Sterile Water for injection 20ml is a sterile, single-dose, non-pyrogenic water designed for injection. Sterile water for injection is used to diss...
What is B Braun water?
B Braun Sterile Water for Irrigation is a high-quality solution used for irrigation. This sterile and nonprogenic solution is PVC and DEHP free and...
What is Hospira sterile water?
Hospira Sterile Water for Injection is a sterile, non-pyrogenic, distilled water in a single-dose vial used for intravenous administration after a...
What is Hospira 50ml?
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...
What is an empty glass vial?
Empty Glass Vial is a clear, sterile glass injection unit that does not contain any water (pyrogen free). Each vial is sterilized with a dry heat p...
Is 5ml sterile water?
Sterile Water for injection 5ml is a sterile, non-pyrogenic water for injection. Preservative free. Made for drug diluent. Dispensed in a single do...
Is a 50 ml vial pyrogen free?
Empty Sterile Glass 50 ml Vials for Injection are pyrogen free. Empty vials are primarily used for mixing different medications or solutions for in...
Is USP sterile or hypotonic?
Choose a category or subcategory. Sterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
Is a diluent a bacteriostatic or antimicrobial agent?
It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. It is a diluent or solvent suitable for intravascular injection after first having been made approximately isotonic by the addition of suitable solute.
Is sterile water a solvent?
Sterile Water for Injection USP is also used as a diluent or solvent for other parenteral drugs. As such, it contributes to hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to approximate isotonicity.
What is water for injection?
NOTE— Water for Injection is intended for use in the preparation of parenteral solutions. Where used for the preparation of parenteral solutions subject to final sterilization, use suitable means to minimize microbial growth, or first render the Water for Injection sterile and, thereafter, protect it from microbial contamination.
Is drinking water prepared from water?
It is prepared from water complying with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations or with the drinking water US P29 regulations of the European Union, Japan, or with the World Health Organization's Guidelines for Drinking Water Quality.
What water should be used for wet granulation?
It should be of USP purified water quality both chemically and microbiologically.
Where is potable water obtained?
USP WFI may be made only by distillation or reverse osmosis. Potable water is obtained primarily from municipal water systems but may also be drawn from wells, rivers, or ponds.
What temperature is USP WFI?
The high temperature, maintained uniformly throughout the system by constant circulation, prevents significant microbial growth. A temperature of 80^oC is commonly used and is acceptable. Somewhat lower temperatures may also be acceptable, provided the firm has adequate data to demonstrate that a lower temperature works as intended. If WFI is held at ambient temperature rather than recirculation at elevated temperature, it must be dumped or diverted to non-WFI use 24 hours after being produced.
What is USP water?
The USP designation means that the water is the subject of an official monograph in the current US PHARMACOPEIA with various specifications for each type. The latter 4 waters are "finished" products that are packaged and labeled as such and need not be of concern during an inspection outside of plants which actually produce these products.
How much chlorine is needed for potable water?
Chlorination of potable water is an effective treatment if minimum levels of 0.2mg/liter of free chlorine are attained. Be aware however, that any carbon or charcoal filters in the system will remove this protective chlorine and thus eliminate any inhibitory effect on microbial growth after this point.
What is corrective facility in pharmaceuticals?
To minimize this contamination, the USP notes that water systems for pharmaceutical manufacturing should have "corrective facilities." By this they mean access to the system for sanitization or introduction of steam, chlorinators, storage at elevated temperatures, filtration, etc. Inquire about these during your inspection.
Is there a microbial standard for water?
GENERAL COMMENT. Although there are no absolute microbial standards for water (other than water intended to be sterile), the CGMP regulations require that appropriate specifications be established and monitored.