.

Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

S. No. Trouble

Possible Cause

Action

1.

Inconsistent weight

(a) (b) (c)

Variation in punch length (lower). Inconsistent granule. Empty feed frame.

(a) (b) (c)

(d) (e) (f) (g)

Brake plug worn out. Dirt underneath weight adjustment ramp. Material loss or gain after proper die fills. Dies not filling.

(d) (e) (f) (g)

Replace or regrind to length Improve granule/mixing technique Check hopper/feeder. Ensure granule flows freely Replace Remove ramp & clean Tail over die missing or not lying flat on die table (i) Reduce speed of machine (ii) Adjust the material flow

Tablet sticks to upper punch

(a)

Damaged upper punch.

(a)

Refurnish punches.

or

replace

(b)

High moisture level in granule

(b)

(i) Dry granules. (ii)Room control. humidity

(c)

Lack of or insufficient lubricant. Insufficient force. compaction

(c)

Add or lubricant.

increase

(d)

(d)

Reduce the thickness within allowable tolerances.

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head

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Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

Double impression

(a) (b)

Worn out brake plugs Excessive tamping

(a) (b)

Replace Decrease tamping force

Flash on tablet edge

(a) (b)

Worn out punch or die If tapered dies are being used tablet being compressed in section of die

(a)

(b)

If possible, reverse die. Replace badly worn punches Increase upper punch entry

Variation in thickness/hardne ss

(a) (b) (c) (d)

(e)

Inconsistent weight. Worn pressure rolls. Variations in upper punch or lower punch lengths. Overload pressure setting set too close to tableting pressure Unequal granule distribution in die cavities.

(a) (b) (c)

See (1) above. Replace Replace or grind length. Reset improve granule

to

(d) (e)

Safety overload pressure release system operating frequently

(a) (b)

Damaged punches (burr on tip) Excessive pressure

(a) (b)

(c)

Overload set too close to tableting pressure

(c)

Refurnish or replace Reduce pressure, i.e., (i) Increase tablet thickness (ii) Reduce fill Rest overload

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head

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Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

Lower punch binding in die

(a) (b)

Material stick to punch or die High moisture level in granules

(a) (b)

Check for worm punches. Dry in oven or FBD, sieve & re-lubricate

Top of tablet is split/cracked

(a) (b)

Damaged punches Granules may be too dry

(a) (b)

Refurnish/replace Add moisture, remix, granulate & re-lubricate

Tablet breaking on take-off

(a) (b) (c) (d)

Take-off plate incorrectly set Lower punch ejection height incorrect Insufficient pressure at compression point

(a) (b) (c) (d)

Check and reset Check and reset. Increase pressure, check overload Reduce speed until acceptable tablet is obtained. Increase binder. Increase moisture level Check hopper and flow of material Check and reset

(e) (f) (g) (h) (i)

Speed too high particular material Not enough binder Granules too dry.

for

(e) (f) (g) (h)

Insufficient feed to dies (soft tablets). Feeder position incorrectly set.

10

Tablet binding in die

(a) (b) (c) (d)

Worn dies. High moisture level in granule. Lack of or insufficient lubricant. Die force surface too rough.

(a) (b) (c) (d)

Reverse or replace. Dry, sieve and lubricate. Increase lubricant.

re-

Hone or lap the die force

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head

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Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

11

Tablet split in half (lamination)

(a) (b) (c) (d) (e) (f)

Take off plate incorrectly set. Lower punch ejection incorrectly set. Speed too high. Insufficient feed to die. Worn/damaged punches. High moisture level in granules Not enough binder in mix. Excess pressure.

(a) (b) (c) (d) (e) (f)

Check and reset. Check and reset. Reduce speed. Check hopper and flow of material. Refurnish or replace. Dry in oven or FBD, sieve and re-lubricate Increase binder.

(g) (h)

(g)

(h) Increase thickness within allowable tolerances. (i) (j) (k) (l) Increase moisture level. Refurnish or replace Check and reset (i) Compress higher in the die. (ii) Reduce press speed. (iii) Reduce cup depth of punches. (iv) Use tapper dies. (v) Reduce quantity of fines in the granulation. Increase pressure at precompression point (i) Reverse dies (ii) Hone or lap die bores (iii) Compress higher in the die Use tapper dies.

(i) (j) (k) (l)

Granules too dry. Burr on punch tips Feeder position incorrectly set. Air entrapment

(m)

Insufficient pressure at precompression point Ringed or barreled die bore

(m)

(n)

(n)

(o)

Too rapid expansion

(o)

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head

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Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

12

Excess material loss

(a) (b) (c) (d) (e) (f) (g) (h)

Feed frame/pedestal Upper punch penetration set too high Worn lower punch or dies Tail over die /scrapper blade, incorrect set /worn Recirculating bend worn or missing Inadequate dust extraction point Excess flow of material to feed frame. Excess sifting (i) Excess lower tip to die bore clearance (ii) Excess fines in the granulation. (iii) Tapered dies installed upside down.

(a) (b) (c) (d) (e) (f) (g) (h)

Check and reset Check and reset Replace Check, reset or replace Replace Reset Reduce flow

(i) Replace (ii) Reduce quantity of fines in the granulation. (iii) Replace

13

Excess machine vibration

(a) (b)

Worn drive belt. Mismatched lengths. punch

(a) (b)

Replace belt Replace or regrind to length Increase tablet thickness and/or reduce weight within allowable tablet tolerance (i)Replace ejection cam if worn out (ii) Need for more lubricant in granulation or use tapered dies Increase release pressure to limit of tools.

(c)

Operating near maximum point of granulation.

(c)

(d)

Heavy ejection pressure.

(d)

(e)

Improper pressure release setting.

(e)

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head

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Eaton Laboratories ANNEXURE: -Troubleshooting Chart for Tablet Compression Process

14

Excess punch head and cam wear

(a) (b)

Damaged track profile Lack of lubricant

(a) (b)

Refurnish/replace lubricate the cam profile

(c)

Rough spot on surfaces of cam profile Damaged outer periphery of pressure roll.

(c)

(d)

(d)

Polish/remove rough spot on surface of cam profile Regrind/replace press roll.

15

Dirt in product (black specks).

(a) (b)

Lack of cleaning. Excess lubrication.

(a) (b)

Need for more frequent cleaning. Use minimum lubrication. Use suitable punch dust cups.

(c)

Punches used dust cups.

without

(c)

Prepared By

Checked By

Approved By

Authorized By

QA Executive

HOD Production

HOD Quality Assurance

Plant Head