PharmSci Exam 1

1. Sterility
2. Pyrogen free

~Sterility is the absence of viable microorganisms.
~Sterilization (destruction) is (1) process or method by which all viable forms of microorganisms are removed or destroyed and (2) the method used is determined by the nature of the product

Sterilization using STEAM
~MOA: hot moisture coagulates cellular protein at a lower temperature due to use of pressure
~Methods: time, temperature, pressure, and steam (ex) 15lbs pressure, 121 degrees C, for 20-60 mins
~Used for: solutions, glassware, surgical dressings, instruments, tubing (items that can be penetrated by water vapor)
!!!don't use for powder, fats, oils, wax!!!

Sterilization using Dry Heat
~MOA: dehydrates the cell, then a slow burn oxidizes the cell
~Method: 250 degrees C (higher than autoclave) for at least 2 hours
~Examples: glassware, instruments, dry chemicals (powders), oils, glycerin, petrolatum.
!!don't use closed tops!!

(chemicals)
~MOA: interferes with cell metabolism
~Method: gas must permeate entire product (50-60 degrees C, 60% humidity, 4-16 hours). Uses ethylene oxide or propylene oxide gas.
~Examples: catheters, needles, plastics, medications (like antibiotics); things that would be destroyed by high heat

(newer)
~MOA: gamma radiations or electron beam
~Safety concerns: ethylene oxide use has been questioned and more heat sensitive devises have been developed. So, radiation has become yet another way to sterilize devices and medications

(Adsorption)
~MOA: micro organisms adhere to the filter
~Method: solution is processed through a filter to remove micro organisms. Aseptic technique must be used
~Examples: heat sensitive products. Products that react with ethylene oxide. Must be in solution
~must use chemical (solution) that doesn't destroy filter

~Range: 0.0025 to 14 microns
~To remove pyrogens use ultrafiltration: 0.001 to 0.01 microns
~to remove bacteria: 0.22 microns (hospitals mostly)
~To clarify (remove glass): 5 microns
~to filter blood: 170 microns
~others to filter lipids (3 in 1=specialized filter, more expensive), alcohols, etc
~filters are easy to use and cheap
~alcohol destroys filters, so has special filters

~USP requirements: if making a batch product, USP spells out testing required for each type of sterilization method. A biologic indicator is used (ex. A spore) to test a statistical random sample of the batch
~QA must show that the product is sterile, non pyrogenic, and of the potency required
~These would be high risk compounded sterile products
~~If sterilizing a single (not a batch) product, sterility must still be proven
~innoculate a sample of product onto a growth media OR filter product and culture filter
~Turbid=cloud (something growing)

~Compound Validation Test Media Kit
~Attack Aseptic Technique Testing and Challenge Kit

Fever producing organic substances arising from microbial contamination of lipopolysaccharides from the microbe's outer cell wall and/or endotoxins. This material may be thermostable and may remain in the product even after sterilization

~water or other aqueous vehicles
~Equipment
~Chemicals
~Containers and closures
~**Human touch, hair

~High heat (240 degrees C, 45 mins). Oxidation occurs. Used for equipment, glassware
~Heat used with a strong alkali or oxidizing agent (ex. Potassium permanganate). May destroy medications
~Adsorption (charcoal or ion exchange resins) May adsorb medications)
~Distillation (used for water)
~Filtration

~USP Pyrogen Test: developed in 1920 by Seibert. Requires animal testing (rabbits>>suceptible to fevers, rabbits are inexpensive but can't tell how much pyrogen present)
~Limulus Test: Developed in 1956 by Bang. Uses limulus amebocyte lysate (LAL) obtained from horseshoe crabs. Sample will coagulate if has pyrogen. Available commercially

~Extraneous mobile undissolved substances, other than gas bubbles, unintentionally present. Often called floateds.
~Sources of contamination: chemicals, packaging components (glass, plastic), insects, filter fibers, PEOPLE (skin and hair)
~Detection: greater than or equal to 50 microns to be seen with the naked eye.