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Manufacturing > Defects > Flashcards

Defects Flashcards

1
Q

Tablet Defects

A

Capping
Lamination
Sticking
Picking
Cracking
Chipping
Double Impression
Mottling
Hardness variations

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2
Q

The partial or complete separation of the top or bottom of a tablet from the main body

A

Capping

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3
Q

Separation into 2 or more distinct horizontal layers

A

Lamination

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4
Q

Cause of Capping and Lamination

A

Entrapped Air

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5
Q

Remedy for Capping & Lamination

A

Change granulation procedure

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6
Q

Adhesion to die

A

Sticking

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7
Q

Cause of Sticking

A

Granules are not properly dried

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8
Q

Remedy for Sticking

A

Reduce moisture content of granules

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9
Q

Adhesion to punches

A

Picking

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10
Q

Fine cracks on the surface

A

Cracking

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11
Q

Cause of Cracking

A

Rapid expansion of table

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12
Q

Remedy for Cracking

A

Change granulation procedure

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13
Q

Breaking of tablet edges

A

Chipping

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14
Q

Cause of Chipping

A

Granules are too dried

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15
Q

Remedy for Chipping

A

Moisten the granules

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16
Q

Defect on tablet during ejection

A

Double impression

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17
Q

Cause of Double Impression

A

Free rotation of punches

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18
Q

Remedy for Double Impression

A

Install anti-turning device

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19
Q

Uneven color distribution

A

Mottling

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20
Q

Cause of Mottling

A

Migration of colors during drying

Improper mixing of granular materials

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21
Q

Remedy for Mottling

A

Reduce drying temperature
Mix properly and reduce size to prevent segragation

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22
Q

Remedy for Hardness variation

A

Maintain weight of tablets

23
Q

Process related defects

A

Capping
Lamination
Cracking

24
Q

Excipient related defects

A

Sticking
Picking
Chipping

25
Q

Machine related defects

A

Double impression

26
Q

Caused by >1 factors

A

Mottling

27
Q

Film Coating Defects

A

Film Cracking (Type I, II)
Rough coating/Orange-peel effect
Bridging and Filling
Blistering
Cratering
Blooming
Sweating

28
Q

Coating cracks in the crown area or split around the edges.

A

Film Cracking Type I, II

29
Q

Cause of Film Cracking Type I

A

Thermal expansion of tablet cores and lack of film flexibility caused by overdrying

29
Q

Cause of Film Cracking Type I

A

Thermal expansion of tablet cores and lack of film flexibility caused by overdrying

29
Q

Cause of Film Cracking Type I

A

Thermal expansion of tablet cores and lack of film flexibility caused by overdrying

29
Q

Cause of Film Cracking Type I

A

Thermal expansion of tablet cores and lack of film flexibility caused by overdrying

30
Q

Cause of Film Cracking Type II

A

Excessive moisture uptake into tablet cores

31
Q

Remedy for Film Cracking Type I

A

Reduce processing temperatures and drying conditions

32
Q

Remedy for Film Cracking Type II

A

Improve drying

33
Q

Coating deposited on the tablet surface is excessively due to failure of spray droplet to coalesce

A

Rough Coating / Orange Peel Effect

34
Q

Cause of Orange Peel Effect

A

Partial Spray Drying

34
Q

Remedy for Orange Peel Effect

A

Reduce & Improve Drying condition

35
Q

Masking of the monogram or bisection, filling-in of the score line or indented logo on the tablet by the film

A

Bridging & Filling

36
Q

Cause of Bridging & Filling

A

Application of too much solution

37
Q

Remedy for Bridging

A

Increase or change plasticizer

38
Q

Reduced adhesion of the film or detachment of film forming blisters

A

Blistering

39
Q

Cause of Blistering

A

Too rapid evaporation of the solvent from the core

40
Q

Remedy for Blistering

A

Apply milder drying condition

41
Q

Appearance of volcanic-like craters

A

Cratering

42
Q

Cause of Cratering

A

Insufficient drying

43
Q

Remedy for Cratering

A

Use efficient and optimum drying conditions

44
Q

Coating becomes dull immediately or after prolonged storage at high temperature

A

Blooming

45
Q

Cause of Blooming

A

High concentration and low molecular weight of plasticizer

46
Q

Remedy for Blooming

A

Decrease concentration and increase molecular weight of plasticizer

47
Q

The presence of an oily film or droplets of liquid on the surface

A

Sweating

48
Q

Cause of Sweating

A

Too much moisture

49
Q

Remedy for sweating

A

Optimum drying condition

Manufacturing (13 decks)

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