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Manuf Lec Midterms > Commercial Manufacturing Extemporaneous Processing > Flashcards

Commercial Manufacturing Extemporaneous Processing Flashcards

1
Q

The process of INCREASING the batch size
Applying SAME process to different output volume

A

Scale up

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2
Q

Processes exist for which ______ simply means enlarging the output by INCREASING the speed

A

Scale up

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3
Q

In moving from R&D to production scale, it is sometimes essential to have

A

Intermediate batch scale

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4
Q

Manufacturing of drug product by a procedure fully representative of and simulating that used for FULL MANUFACTURING SCALE

A

Pilot scale

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5
Q

This scale also makes possible the production of enough product for

A

Clinical testing
Samples for marketing

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6
Q

One way to eliminate potential scale up problems is to develop

A

Formulations that are very robust

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7
Q

ISOLATION of a single chemical constituent of chemically related substance

A

Separation

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8
Q

Separation process

Uses a SINGLE mechanical manipulation

A

Simple process

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9
Q

Used to separate two IMMISCIBLE liquids

A

Separatory funnel

Ethyl acetate+Chloroform
Peppermint+Water

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10
Q

Processes under simple process

A

Separatory funnel
Distillation
Garbling
Centrifugation

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11
Q

Used to separate two MISCIBLE liquids

A

Distillation

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12
Q

Used to separate two SOLIDS

A

Garbling

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13
Q

Used to separate SOLID from LIQUID

A

Centrifugation, filtration, expression

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14
Q

Separation process

It requires the formation of a SECOND PHASE + mechanical manipulation

A

Complex process

ASA from salicylic acid - recrystallize ASA

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15
Q

Separation process where an OPTICALLY TRANSPARENT liquid is obtained that passes through a POROUS substance

A

Filtration

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16
Q

In filtration the LIQUID OBTAINED is called

A

Filtrate

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17
Q

What is easier to filter larger or smaller particles

A

Larger particles

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18
Q

Smaller particles:

A

HINDERS FILTRATE
Have the tendency to occlude the pores
Build up on the filter form a non-porous, densely packed bed

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19
Q

Has channels that impart POROSITY

A

Filtering media

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20
Q

Full of TINY HOLES that water or air can get through

A

Porosity

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21
Q

Ability of the filter medium to ELIMINATE SOLID material from the liquid

A

Retention

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22
Q

SPEED at which the purified liquid or filtrate is recovered

A

Filtration rate

23
Q

Speed of the FLOW of the liquid through the filter bed
Retarded by the

A

Flow rate

Viscosity of the liquid

24
Q

Types of filtering media

A

Filter paper
Membrane filters
Cotton filters
Glass wool filters
Sintered glass filters

25
Q

Types of filtering media

Folded or fluted

A

Filter paper

26
Q

Types of filtering media

Similar to cloth
Pure or derived cellulose products with UNIFORM MICROPORE STRUCTURE (10nm to 10um)
Used in

A

Membrane filters

Chemical, microbiological, bacterial analyses

27
Q

Types of filtering media

Absorbent
Loosely inserted in the neck of the funnel
Disadvantage?

A

Cotton filters

Refiltration

28
Q

Types of filtering media

Resistant to chemical action= used for highly reactive chemicals

A

Glass wool filters

29
Q

Types of filtering media

Flat or convex plate with JENA POWDERED glass molded together
Vacuum attachment
Used to filter?

A

Sintered glass filters

Parenteral solutions

30
Q

What to do for filtration of volatile liquid to avoid loss or explosion

A

Cover the funnel and the receiving vessel

31
Q

They increase EFFICIENCY of the filtration process

Must be

A

Adsorbents

Soluble and inert

32
Q

It is not the palpable kind

A

Purified talc

33
Q

INCAPABLE of being felt by touch; so FINELY divided that no grains or grit can be felt

A

Impalpable

34
Q

Used for GENERAL filtration process
Inert
Adsorbs liquid

A

Kieselghur or pure silica

35
Q

Fuller’s earth or kaolin in HYDRATED form
Used to filter FIXED OILS but should not be used for liquid with coloring matter or alkaloidal principles

A

Siliceous earth or clay

36
Q

Adsorbs color, odor, alkaloids, and glycosides

A

Charcoal

37
Q

READILY react with acids and possess a FINITE solubility in water with a production of an alkaline aqueous solution which can PRECIPITATE alkaloids

NOT for?

A

Chalk, Magnesium carbonate

General filtration processes

38
Q

AIDS in the filtration processes
Can use PUMP-ACTING process by water pressure where no leaks should be present in the connections

Example?

A

Vacuum filtration

Buchner filter (common)
Gooch crucible perforated
Flask

39
Q

The process by which FINELY divided solids and colloidal materials are separated from liquids WITHOUT the use of filters

Employed when?

Tend to plug a?

A

Clarification

FINELY subdivided, amorphous or colloidal in nature

Filtration medium rapidly

40
Q

Method of clarification
SIMPLEST method- least amount of labor and expense

The sediment formed is a _____ which separates due to GRAVITY from a liquid

Example?

A

Gravitational method

Sludge

Fixed oils and vegetable oils

41
Q

Method of clarification
It is added, shaken and removed by filtration

Acts to _____ by physical adsorption

Example?

A

Clarifying agent

Reduce turbidity

Paper, Talc albumin, Gelatin and polyamines

42
Q

A process of DEPRIVING solutions of color by use of an adsorptive medium

Example?

A

Decolorization

Animal charcoal/bone black, wood charcoal, activated charcoal, bentonite, kaolin, fuller’s earth

43
Q

Difference of adsorption to absorption

A

Adsorption: particles stick to the surface
Absorption: enters the cell

44
Q

The SIMPLEST method for the separation of a solid from it’s soluble impurities
Involves WASHING and subsequent AGITATION of the solid

Repeated to attain the degree of

Conveniently done with a _____ that is not filled to capacity

_____ used as a guide to STEADY the hand of the operator

A

Decantation

Desired purity

Lipped vessel

Stirring rod

45
Q

STRAINING
It separates the solid from the liquid by pouring the mixture on a CLOTH or POROUS material that will permit the fluid to pass through but will retain the solid

It is filtration using _____ in the straining medium/cloth which is colorless and washed before use

A

Colation

Larger pores

46
Q

FORCIBLY separating liquids from solids

A

Expression

47
Q

Methods of expression
BEST method that uses a cloth

A

Spiral twist test

48
Q

Method of expression
For LARGE SCALE pressing of oily seeds, fatty substances
_____ must be taken to apply the force gradually and not to use it on _____

What material does it use

A

Roller press

Care, corrosive materials

Rubber

49
Q

Method of expression
EXPENSIVE but most economical in terms of increased power with least labor
The principle is based on the fact that pressure exerted upon an enclosed liquid is transmitted _____ in all directions

A

Hydrostatic or hydraulic press

Equally

To extract active constituents

50
Q

Steps of precipitation and recrystallization
Evaporate solvent= cool= formation of crystals

A

Supersaturation

51
Q

Steps of precipitation and recrystallization
Thought to consist of 10 to a few hundred of molecules having the SPATIAL ARRANGEMENT of the crystals that will be grown ultimately from them

A

Formation of nuclei

52
Q

Steps of precipitation and recrystallization
Suspension= formation of HARD CAKE or also known as?

A

Growth of crystals

Oswald ripening

53
Q

Depending on the conditions of crystallization, it is possible to control or modify the nature of crystals obtained

Careful TEMPERATURE CONTROL and SEEDING with desired crystal form is necessary

A

Existence of polymorphs

54
Q

Depending on the conditions of crystallization, it is possible to control or modify the nature of crystals obtained

Depends highly on IMPURITIES in the solution, pH, rate of stirring, rate of cooling and the solvent

A

The habit or shape of the crystal form

Manuf Lec Midterms (2 decks)

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