[REVIEW] MANUF PROCESSES, COMPOUNDING, AND DEFECTS

digestion

extraction with GENTLE heat

decoction

extraction with BOILING water for SHORT time

infusion

maceration in hot or cold water for LONG time

maceration

any type of extraction that involves soaking

glass

material of mortar/pestle for chemicals that stain

wedgewood

material of mortar/pestle for crystalline substances

percolation

process P for tinctures

maceration

process M for tinctures

simple solution

preparation method for aromatic ammonia spirit

maceration

preparation method for peppermint spirit

chemical reaction

preparation method for ethyl nitrite

distillation

preparation method for brandy or whisky

percolation

process A for fluidextracts

percolation with shorter diameter and longer length

process E for fluidextracts

use boiling water

process D for fluidextracts

geometric dilution

mixing of powders for potent substances

continental

other name of dry gum method

english

other name of wet gum method

forbes bottle method

emulsion preparation for volatile oils and less viscous oils

in situ soap method

emulsion preparation for fats, fixed oils and alkali

primary

manufacturing of API and excipients

secondary

manufacture of finished dosage form

tertiary

manufacture that includes labeling or packaging

toll

company manufactures products for another

overage

addition of API to compensate for loss

batch

specific quantity of product in one manuf process

quarantine

area for holding of incoming components

validation

documented evidence that system does what it's supposed to do

primary

packaging on immediate container

secondary

outer packaging

well-closed

protects from extraneous solids

tight

just like well-closed, but also includes liquids and vapors

hermetic

impervious to air

5 years

child-resistant refers to what age of children?

tamper-resistant

has an indicator that provides evidence of breach

cutter

milling using knives

edge runner

mills using 2 rotating wheels

hammer

mills using a high speed rotor

fluid energy

mills using air with very high pressure

roller

mills using rotating cylindrical rolls

ball

mills using cylindrical rolls filled with balls

fluid bed

graulation with dry mixing and wet granulation

wet granulation

most common granulation

dry granulation

granulation for heat-sensitive materials

hopper

part of tableting machine that holds materials

feed shoe

part of tableting machine that transfers materials into die

die

part of tableting machine that defines size and shape of tablet

punches

part of tableting machine that compresses

cam tracks

part of tableting machine that guides movement of dies

flowability and compressibility

requirements of tableting

capping

separation of top or bottom crown

lamination

separation into 2 or more distinct horizontal layers

chipping

removal of small portion

cracking

fine cracks on surface

sticking

adhesion to die wall

picking

adhesion to punch faces

double impression

two indents due to free rotation of punches

mottling

uneven color distribution

sealing

process of coating that strengthens tablet core

subcoating

adds most weight in coating

grossing

part of color coating that develops color

sugar coating

oldest method of coating

alloying substance

part of film coating that gives water solubility/permeability

sweating

film defect - oily film or droplets of liquid

bridging

markings in a tablet are obscured

orange peel

rough, nonglossy film surface

reciprocating die

most common method of hard gel cap manufacture

plate process

oldest method of soft gel cap formation

rotary die process

uses gelatin ribbons for soft gel cap formation

fusion

use of heat to produce ointments

304 and 316

two most inert stainless steel grades

methylparaben

paraben for molds

propylparaben

paraben for yeasts and bacteria

true antioxidants

type of antioxidant: vit E, BHT, BHA

reducing agent

includes vitamin C and sulites

gravimetric

filling method for large containers and high viscosity

sedimentation

when dispersed liquid phase sinks

creaming

when dispersed liquid phase rises

cracking

separation of layers in emulsion

caking

permanent settling of suspensoids

121 C, 15 psi, 15-20 mins

details of moist heat sterilization

170 C, 2-4 hrs

details of dry heat sterilization

B. stearothermophilus

indicator for moist heat

B. subtilis

indicator for dry heat

B. subtilis

indicator for gas sterilization

B. pumilus

indicator for ionizing radiation

99.97%, >= 0.3 microns

percent of particles and their particle size removed from air by HEPA

DOP test

QC test for HEPA filter

tip/ bead sealing

sealing ampules via melting to form a bead

pull sealing

sealing ampules by melting below tip then pulling away