Sterile water production

In the past ten to fifteen years or so, the applications sphere of cross-flow filtration has been extended to include microfiltration (MF) which primarily deals with the filtration of colloidal or particulate suspensions with size ranging from 0.02 to about 10 microns. Microfiltration applications are rapidly developing and range from sterile water production to clarification of beverages and fermentation products and concentration of cell mass, yeast, E-coli and other media in biotechnology related applications. 

Processing in Hquid sterilants results in wet products which require highly specialized packaging. Therefore, Hquid sterilization should only be considered if the sterilized article is to be used almost immediately. Liquid sterilants or their residues can be harmful to living tissues. Therefore it is always necessary to rinse articles with sterile water or saline solution foUowing treatment. Whereas Hquid sterilization is an extremely useful method for articles that caimot withstand the conditions of steam sterilization, the problems associated with its use limit its appHcation. 

Membrane-retained components are collectively called concentrate or retentate. Materials permeating the membrane are called filtrate, ultrafiltrate, or permeate. It is the objective of ultrafiltration to recover or concentrate particular species in the retentate (eg, latex concentration, pigment recovery, protein recovery from cheese and casein wheys, and concentration of proteins for biopharmaceuticals) or to produce a purified permeate (eg, sewage treatment, production of sterile water or antibiotics, etc). Diafiltration is a specific ultrafiltration process in which the retentate is further purified or the permeable sohds are extracted further by the addition of water or, in the case of proteins, buffer to the retentate. 

For MPN determination, sterile pipettes calibrated in 0.1-ml increments are used. Other equipment includes sterile screw-top dilution bottles containing 99 ml of water and a rack containing six sets of five lactose broth fermentation tubes. A sterile pipette is used to transfer 1.0-ml portions of the sample into each of five fermentation tubes. This is followed by dispensing 0.1 ml into a second set of five. For the next higher dilution (the third), only 0.01 ml of sample water is required. This small quantity is very difficult to pipette accurately, so 1.0 ml of sample is placed in a dilution bottle containing 99 ml of sterile water and mixed. The 1.0-ml portions containing 0.01 ml of the surface water sample are then pipetted into the third set of five tubes. The fourth set receives 0.1 ml from this same dilution bottle. The process is then carried one more step by transferring 1.0 ml from the first dilution bottle into 99 ml of water in the second for another hundredfold dilution. Portions from this dilution bottle are pipetted into the fifth and sixth tube sets. After incubation (48 h at 35 C), the tubes are examined for gas production and the number of positive reactions for each of the serial dilutions is recorded. 

Mains drinking water is not sterile. Water regulations state that it must contain less than one faecal coliform bacterium per 100 cm3 but concentrations of 103/cm3 of Pseudomonads, one of the main causative organism in industrial product spoilage, are quite common and can lead to infection. 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

A 25 mL vial of NaCl solution was diluted to a liter with sterile water for injection. The concentration (w/v) of the NaCl in the finished product was 0.9%. What was the concentration in terms of mEq/mL, of the original solution ... 

PEG-Intron PEG-Intron is used for the treatment of hepatitis C. The product consists of a covalent conjugate of the recombinant interferon- -2b with monomethoxy polyethylene glycol (PEG) supplied in vials with 74/rg, 118.4/rg, 177.6/rg, or 222/rg of the active ingredient and 1.11 mg sodium phosphate (dibasic,anhydrous),l.ll mg sodium phosphate (monobasic, dihydrate), 59.2 mg sucrose, and 0.074mg polysorbate 80. The powder is reconstituted with sterile water-for-injection. 

Admixture compatibility- Digoxin injection can be administered undiluted or diluted with a 4-fold or greater volume of sterile water for injection, 0.9% sodium chloride injection, or 5% dextrose injection. The use of less than 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended. 

Dosage form Prolastin is supplied in single-use vials with the total alphai-proteinase inhibitor functional activity, in milligrams, 500 or 1000, stated on the label of each vial. A suitable volume of sterile water for injection is provided. When the product is reconstituted it contains Prolastin 25mg/ml. 

At the end of approval cleaning, the equipment should be rinsed with sterile water for injection. The water for hnal rinse shall be tested for its conductivity. As an alternative, run a placebo batch after a production batch and subsequent cleaning. Analyze the samples of placebo batch for the active ingredients of the previous run batch to ensure that there is no cross-contamination. 

U.S. Pharmacopeia (USP) (2007), Application of water activity determination to non-sterile pharmaceutical products, general chapter <1112>, U.S. Pharmacopeial Convention, Rockville, MD. 

Unit vial 212 units reconstituted with 5.1 mL sterile water to a final volume of 5.3 mL of reconstituted product (40 U/mL) (pH = 6.1)... 

Bottle systems are more varied, whether for glass, polyethylene terephtha-late (PET) or other plastic. Bottles are rinsed with oxonia solution and then sterile water prior to filling. The filler is generally of a non-contact type (it does not touch the bottles) and product is either weighed in or measured volumetrically. Caps are also chemically sterilised (unless a foil closure is used) and applied on a capper monoblocked with the filler, enclosed in a high efficiency pure air (HEPA) filtered enclosure. The filler and final rinser are in a class 100 room and file operator wears full protective clothing to prevent infection of the product. 

More recently, ozone has been found to be particularly suitable as a sterilant in bottled water and ultra-high purity water production. 

Fig. 30.2. Agarose gel electrophoresis of PCR product (lane 2) obtained from S. enterica serovar Typhimurium ATCC 15038. Lane 1 Molecular weight marker (<1>X174-Hinf I genome). No band was obtained with sterile water used as a negative PCR control (lane 3).

There are several other HCG brands including veterinary. HCG always comes in two vials one contains a packed powder and the other contains sterile water. Once the product is mixed (swirled not shaken) it must be refrigerated. HCG was often what bogus Growth Hormone (GH) vials contained. A simple test for real GH was to buy a pregnancy test kit and drop a few drops into the test. If your test read pregnant, you are also screwed. This is because most test kits test for elevated gonadotropins and HCG will test as such, but GH will not. 

Abstract. Water-soluble polymers of acrylamide and acrylic acid with high extent ( 90%) of Ceo consumption are obtained by technique of low-temperature radiation living radical polymerization. In absorption spectra of these copolymers one can see gradually descended unstructured absorption in the range 240-700 mn, characteristic for fullerene covalent-bound or its klasters. The way of radiation initiation is used to obtain the products of high purity, because it is not necessary to embed into the system any initiators or catalyst. Latter is very important in the case of synthesis of polymers for medical purposes. Also at radiation initiation a rate of initiation reaction does not depend on the temperature and the sterilization of products takes place simultaneously. 

When performing experiments with cells for a long-time period, following exposure one is required to perform electroendocytosis under sterile conditions. Thus, the electrodes are sterilized with 70% ethanol for 30 min, with subsequent washing with sterile water and drying under laminar flow. Sterile cuvettes (e.g., from Elkay Products, Inc., Shrewsbury, MA, USA) should be used, and the whole procedure of electric treatment and incubation should be performed in a laminar hood. 

The vehicle or solvent, which is of greatest importance for parental products, is specially distilled, pyrogen-free water. The container of choice is glass. Sterile water is used for the solution or suspension of drugs that are prepared just before injection. 

The most widely used solvent for SVIs is water for injection (WFI), USP. As a solvent, WFI is used in preparing the bulk solution (compounding) and as a final rinse for equipment and packaging preparation. WFI is prepared by distillation or reverse osmosis, although only distillation is permitted for sterile water for injection, USP. Sterile water for injection is used as a vehicle for reconstitution of sterile solid products... 

Water used in manufacture of sterile parenteral products must comply with pharmacopeial limits for endotoxin of no more than 0.25EU/ml (limits in the USP and PhEur for water for injection). In principle water complying with this limit can be produced by... 

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