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The regulatory processes though which industry measures actual quality performance, compares it with standards and acts on the difference.
Raw material control
evaluate components used in the product
assure specifications of the tests and procedures used
assure that the finished product meets the established specifications
Record temp at 1, 2 and 3 hours after drug administration.
1st Stage of Rabbit test
Total of 3 max readings for each rabbit >1.4 fails
2nd Stage of Rabbit Pyrogen Test
24 total readings
Any 4 readings
Total of 8 rabbits max temp >3.7 fails
Limulus Test (LAL)
Limulus Amebocyte Lysate
Limulus Test Procedure
amebocyte lysate causes gelation of the solution within an hour at 37C.
Who needs TPN?
TPN is needed when adequate nutritional intake cannot be provided by the oral route.
7 conditions of TPNs
Long injection time
Multiple drug therapy and vital organ support
Contains fat, glucose and protein
Potential side effects of TPN
Calories from Dextrose
Calories from Proteins
Calories from Fat
Consequences of Fat Deficiency
Fatty acids help keep blood from clotting, lower cholesterol and prevent cancer cell growth.
Safe Handling Guidelines for Antineoplastic Agents
1. Biological Safety Cabinet (class II)
2. Vertical Flow Hood
3. Fill syringes no more than 3/4 full
4. Protective apparel
5. Negative pressure - 0.2 mM filter
6. Final Adjustment of fluid
9. Waste Disposal
10. Spill kits
an agent which softens or soothes the skin
act of closure or state of being closed. Trapping material within cover or film
liquid molecules within either solid or liquid-crystalline material.
Material retains shape until acted upon by an outside force.
Plastic behavior allows uniformity in spreading over a surface.
Hydrocarbon Ointment Base
Ex. White Petrolatum
Ex. Silicone ointment
contains polydimethylsiloxane oil
Absorption Bases - Emulsion Base
Ex. Lanolin, cold cream
Contains water/absorbs additional water
Absorption Base - Anhydrous
Water Removable Base
Can be diluted with water
Water Soluble Bases
Polyethylene Glycol Ointment
Water-soluble and washable
Fusion A Method
heat materials together in a homogenous melt at 60-80C.
Fusion B Method
Heat all phases separately. 60-80C.
Add emulsifiers to water phase.
Add oil phase to water phase
portion of powder mixed with portion of base
Add all solid to a portion of base
Then add more base until mixed
Benefits and Risks of Topical Preservatives
Irritating to skin