Between planned maintenance visits

Keep tablet testing controlled.

A practical cross-platform routine for controlled dimensions, strength, friability and disintegration testing.

TABLET TESTINGTablet physical testing housekeeping guide
Small mechanical changes can move a physical result.Clean contact surfaces, correct accessories and controlled force, motion, time and temperature protect tablet-test integrity between qualification and service events.

Take the routine into the laboratory

Choose a practical monthly task sheet for a physical instrument folder or an electronically completed laboratory record.

↓ Print-friendly PDF2-page A4 landscape · Rev 02
Low-ink version for printing
↓ Electronic record PDF2-page A4 landscape · Rev 02
Full-colour · complete and save electronically
Annual servicing is one important control—not a year-round maintenance strategy.
Tablet physical-testing equipment experiences product dust, fragments, repeated mechanical loading, bath use and accessory change throughout the year. Its condition needs maintaining between service visits through prompt cleaning, setup checks, performance review and timely response to drift, damage or abnormal movement.
ICHQ4B Annex 5(R1) · Disintegration Test ↗
Laboratory action

The laboratory’s role

Select the frequency that applies today and complete the checks shown.

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Pause and investigate when you see:

Small changes can become preventable failures when they are allowed to persist.

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Force, dimension or zero driftA reference or routine result moves from its established trend, zero will not hold or measurement repeatability deteriorates.
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Irregular break or tablet positioningTablets chip, stick, rotate, break atypically or enter the measuring station inconsistently.
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Drum, basket or accessory damageMesh, tubes, discs, baffles, shafts, drums, jaws or measuring surfaces are bent, worn, loose, obstructed or incomplete.
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Timing, speed or movement concernA rotation, stroke, feed or cycle hesitates, varies, rubs, vibrates or triggers an error.
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Temperature or bath concernA disintegration bath is slow to equilibrate, differs across positions, loses circulation or shows contamination or evaporation effects.
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Data, print or communication gapA result, sample identity, audit evidence, printout or transfer is missing, duplicated or inconsistent with the observed test.
One care standard · three OEM perspectives

Apply the routine to your instrument

Start with the cross-platform routine, then use the emphasis relevant to your installed system.

Exact commands, parts, intervals and acceptance criteria remain model- and method-specific.

Evidence and source library

Harmonised compendial, regulatory and OEM material supporting this cross-platform practical guide.

Primary sources
ICH Q4B Annex 5(R1) · Disintegration Test General ChapterOfficial harmonisation outcome for recognised pharmacopoeial disintegration procedures, with region-specific considerations. Apply the current monograph and approved product criteria.
Open ICH PDF ↗
ICH Q4B Annex 9(R1) · Tablet Friability General ChapterOfficial harmonisation outcome for tablet-friability procedures, with region-specific considerations. It does not replace the current product specification.
Open ICH PDF ↗
USP <1217> · Tablet Breaking Force | Ph. Eur. 2.9.8 · Resistance to crushing of tabletsApply the current controlled compendial editions. Breaking force depends on orientation, geometry and tester operating characteristics; acceptance criteria remain product-specific.
Controlled chapters
FDA / eCFR · 21 CFR §211.160Laboratory controls, specifications, sampling and testing under US pharmaceutical CGMP where applicable.
View regulation ↗

References are provided for transparency. Current pharmacopoeial texts, product monograph, validated method and specification remain authoritative. ICH Q4B annexes describe regulatory interchangeability with stated regional considerations; they do not create universal product acceptance criteria. Configuration, cleaning, accessories, verification, software and service procedures remain model-specific. Dissolution is covered by the separate Lab Optimise guide.

Lab Optimise practical laboratory guides

A growing cross-platform collection for laboratory care between planned maintenance visits.