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 necessary. All of the numbers the labs have determined are on the high side just to be safe. I have always recommend 250-275 with emphasis on 275.
we have already determined that BA is a preservative and not a sterilizing 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 interesting 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. .
**TAKEN FROM BK**