Sterile product Part 2

Solvent, co-solvent, suspending agent/emulsifier, tonicity adjuster is what

structure

1. Buffer, antioxidant, chelating agents, cryoprotectants is what stability

chemical

1. Antimicrobial agents is what stability

antimicrobial agents

1.  - must be PYROGEN FREE, but not necessarily sterile

   1. Used for injectable products sterilized after preparation is for what

water for injection

1. must be STERILE and PYROGEN-FREE

Used for reconstitution of antibiotics is what

sterile water for injection

1. STERILE, PYROGEN-FREE, ANTIMICROBIAL AGENTS (preservatives); containing one or more suitable antimicrobial agents is what

bacteriostatic water for injections

1. Non-irritating, non-toxic, non-sensitizing, no pharmacological activity, no effect on the pharmacological activity of the therapeutic agent

2. Examples: Glycerin, Polyethylene Glycols, Propylene Glycol, Fixed Vegetable Oils

Cannot be used: oils that contain Mineral Oil or Paraffin

non aqueous vehicles

1. Ex: Benzyl alcohol, Meta-Cresol, Phenol, Methyl & Propyl Paraben, Chlorobutanol, Thimerosal is what

different types if antimicrobial

1. Hypertonic (cell shrivels), Isotonic (cell is in homeostasis), Hypotonic (cell bursts) are what

tonicity

1. . Sodium chloride 0.9%, dextrose 5% are examples of what

tonicity adjusting agents

1. Acceptable pH is always 3-9 for IV preparations and 4-8 for other routes (true or false)

true

pH > 9 is what

tissue necrosis

pH < 3 is what

pain and phlebitis

1. HCl, NaCl are what

examples of ph adjusting agents

1. when you have antioxidants, it inhibits oxidation of active ingredient (true or false)

true

1. Ascorbic acid, alpha tocopherol, butylated hydroxyanisole, sodium metabisulfite, EDTA are examples of what

antioxidants

1. Process of drying in which water is removed from the product after it is frozen. 

2. Purpose: Used to increase stability in an aqueous solution or suspension

for what

freezing drying (lyophilization)

1. Long-term stability, short reconstitution time, elegant cake appearance, maintenance of the characteristics of the original dosage form upon reconstitution is what

advantage of freeze drying (lyophilization)

1. Most time-consuming, required specialized equipment, increased product development & manufacturing steps is what

disadvantages of freeze drying (lyophilization)

1.  Saturation of steam at high pressure. Does not remove pyrogens. Cheap, inexpensive, fast. Most widely used method is what sterilization

steam sterilization

1. Uses higher temperature & time → “The main mechanism of destruction is by the high pressure for sufficiently high periods of time resulting in the denaturation of essential proteins of the microorganism.” is what sterilization

dry heat sterilization

1. Physical removal of bacteria w/ bacteria-retentive filters (use either positive or negative pressure)

2. Advantage: non-thermal method, useful for biologics

3. Bubble point test - non destructive test to estimate pore size. 

is what

filtration

1. Using Ethylene Oxide Gas. not appropriate for solutions. Explosive hazard, toxic is what

gas sterilization

1. Using UV light. Useful for thermolabile materials. (most common = radiation from cobalt-60) is what

radiation sterilization

1. Indicators (spores) used to monitor & validate the sterilization process is what

biological indicators

1. LAL (Limulus Amebocytes Lysate) is used to identify or detect endotoxins

   1. LAL reagent: enzyme extract from the blood cells of the horse-shoe crab coagulate in the presence of low levels of endotoxin is what

bacterial endotoxins test

1. Definition: Any viable or non-viable particle. Number of particles represents air quality.

   1. ISO class 5 is what

particulate matter

1. no more than 3 components is what kind of contamination

low

1. more than 3 components, no antimicrobial preservative & product given over more than 2 days is what contamination

medium

1. non-sterile ingredients used (e.g. NaCl), need sterilization of end product is what contamination

high