GuideAppendix A

Typical Parameters

Reference values only. The BMR, product specification and validated process always take precedence.

Parameter	Typical value	Notes
Blender fill level	40–60% of gross volume	About 50% is common.
Tumble blender speed	10–30 rpm	Larger blenders run slower.
Main blend time	10–20 minutes	As validated.
Lubrication blend time	2–5 minutes	As validated.
Blend uniformity	Individual 90–110% of mean; RSD ≤ 5%	Or per specification.
Uniformity sample locations	≥ 10	Top, middle, bottom; legs and apex.
Uniformity sample size	1–3 × unit dose weight
Drum QA sample	≈ 50 g per drum	Or per sampling plan.
Moisture sample size	2–5 g	Per method.
Density cylinder	100 or 250 mL
Tapped density taps	10 / 500 / 1,250 (+1,250)	3 mm drop, 250 taps/min.
Good flow	Carr ≤ 15%; Hausner ≤ 1.18
Balance warm-up	30–60 minutes
Balance room	20 ± 2 °C, 45–55% RH
Calibration weights	OIML E2 or F1	Accredited traceability.
Small vibratory screen load	< 3 kg	Per manufacturer.

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