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Sterilization
1.Definition
* Not producing or incapable of producing offspring.
a. Not producing or incapable of producing seed, fruit spores, or other
reproductive structures. Used of plants or their parts.
b. Producing little or no vegetation; unfruitful: sterile land
* Free from live bacteria or other microorganisms: a sterile operating area;
sterile instruments.
*Sterilization
Drying or freezing kills many species of bacteria and causes others to become
inactive. Heat above a certain temperature kills all bacteria. Sterilization of
objects such as surgical instruments is an important part of bacteriological
work.
Antiseptic :1 a : [opposing sepsis, putrefaction, or decay; especially :
preventing or arresting the growth of microorganisms (as on living tissue) b :
acting or protecting like an antiseptic]
Antiseptics, physical or chemical agents that prevent decay and infection by
destroying microorganisms. Antiseptics are used for food preservation (see Food
Processing and Preservation), sterilization of water in public water systems,
and medicine. English surgeon Joseph Lister initiated the use of antiseptics to
treat wounds when he developed a carbolic acid solution in 1868. Major
antiseptics used since then include bichloride of mercury, iodine, boric acid,
alcohol, bchlorine, and the hypochlorites.
Definition
1. The act or procedure of sterilizing.
2. The condition of being sterile or sterilized.
<Preparation of dosage forms>
Sterile medicaments.
Some drugs cannot be given orally, because they are decomposed by the digestive
processes; these drugs must be administered by injection, intravenously,
intramuscularly, or subcutaneously (under the skin). It is imperative that such
injected solutions be free from microorganisms or toxic agents; other
pharmaceutical preparations that must be sterile include eyedrops, eye lotions,
eye ointments, implants, powders to be applied to wounds or body cavities, and
any solution or preparation to be used in surgical operations, such as surgical
dressings, ligatures, and sutures. (see also Index: sterilization)
There are several main methods for preparing sterile products. Steam
sterilization is carried out in an enclosed chamber (autoclave). The material is
distributed into its final containers, which are sealed to exclude
microorganisms. The containers are then placed in the autoclave and subjected to
saturated steam under pressure at a temperature of 121 C (250 F) for 15 minutes.
Substances stable in heat may be sterilized at higher temperatures, for which a
shorter heating period is sufficient; conversely, lower temperatures require
longer sterilization periods.
Pharmaceuticals in which the solvent is not water cannot be sterilized by steam,
so dry heat at temperatures of 140 C (284 F) or higher is used, with exposure
times ranging from one to four hours. The temperature-time relationship is
similar to that for steam sterilization. Another technique is gaseous
sterilization, in which the material is exposed to a vapour or gas such as
ethylene oxide; this method is much used for foods, biologicals, and medical
equipment (e.g., cotton wool, syringes, needles, and tubing). Radiation
sterilization generally involves exposure to ultraviolet or gamma radiation or
high-energy electrons; its use is limited mainly to the production of sterile
medicaments and apparatus on a large scale. The final method, aseptic
manipulation, is not actually a sterilization process. Here, the separate
ingredients of the pharmaceutical are all available in sterile form and merely
require compounding without microbial contamination.
Injections are aqueous or oily solutions, suspensions or emulsions, prepared by
normal methods, with special care taken to remove all extraneous particulate
matter. Injections must be sterilized by one of the methods given above. Some
aqueous injections are not stable and so are prepared at the time of use by
adding sterile water to the sterile drug.
Eyedrops, eye lotions, and eye ointments are all prepared by general methods,
but they must be sterile. The pH value (acid-alkaline content) of eyedrops and
eye lotions is important; a compromise must be made between the ideal value of
7.4 (almost neutral) and the value of greatest stability or therapeutic
activity. Implants or pellets are prepared either by fusion and molding of the
drug or by compression of the sterile crystals.
OK fellas for you that have read this now you see why i bake. I also bake at 280
or so normally. the stoppers will not melt if the rack is lowered in the oven
well away from the top. let the oven preheat then place vial/vials in oven for a
minimum of 1 hour. Turn the oven off and let cool to room temp before removing
product. Make sure to calibrate you ovens from time to time with a thermometer.
If you do study this out you will find some data showing that 340f for 2 hours
is needed. After working in the Pharm business for several years, for our
application, this is not necessarry. All of the numbers the labs have determined
are on the high side just to be safe. I have always recommened 250-275 with
emphasis on 275.
we have already determined that BA is a preservative and not a sterlizing agent
in previous discussions. Pressure filtration in conjunction with heat
sterlization is the safest route we have to making a sterile product for Sub-Q,
IM injection or depot. Now this just applies to oily solutions/suspensions.
Aqueous solutions/suspensions normally require autoclaving in conjunction with
antimicrobials.
hope you guys found this intersting and that all read it who are considering
home brewing. There some nasty stuff out there that can cripple or kill if it is
injected into your body. Be smart and play it safe. .
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