Calibration Criteria

 

CHEMICAL CALIBRATION / CALIBRATOR TABLETS

 

USP

JP

BP

EP

PhRMA

FDA/DPA

Calibrator Tablets

6 Non Disintegrating, App. 1

6 Non Disintegrating, App.2

6 Disintegrating, App.1

6 Disintegrating, App 2

None

None

None

In House Calibrator

 

 

MECHANICAL CALIBRATION TOLERANCES, APPARATUS 1 (BASKET) AND APPARATUS 2 (PADDLE)

Calibration Parameter

USP

 

JP

 

BP

 

EP

PhRMA Proposed

DPA

Vessel dimensions

(Inspect at time of receipt

only)

Internal diameter 98-106 mm

External Height 160-210mm

Hemispherical bottom, 1000ml

Internal diameter 98-106 mm

Internal height 160-175 mm

Round bottom, 1000ml

Internal diameter 98-106 mm

Internal height 160-176 mm

Hemispherical bottom, 1000ml

Internal diameter 98-106 mm

Internal height 160-176 mm

Hemispherical bottom, 1000ml

Same as USP

Same as USP

Basket dimensions (Inspect at time of receipt only)

Conforms to diagram in USP

Mesh Size 0.40 +/- 0.04mm

Conforms to diagram in JP (Almost identical to USP)

Mesh Size 0.425mm

Same as EU

Conforms to diagram in EU (Almost identical to USP)

Mesh Size 0.381mm

Same as USP

Same as USP

Paddle dimensions (Inspect at time of receipt only)

Conforms to diagram in USP

Conforms to diagram in JP (Same as USP)

Same as EU

Conforms to diagram in EU (Almost identical to USP)

Same as USP

Same as USP

Visual inspection of

belts, check ball bearings

 

None

 

 

None

None

None

Belts are tight, clean free of cracks, properly aligned, shafts turn freely

Belts are tight, clean free of cracks, properly aligned, shafts turn freely

Bath levelness

 

None

None

None

None

Level

Bubble within lines of a bubble level

 

Shaft verticality

 

None

None

None

None

Vertical as measured by a bubble level

Bubble within lines of a bubble level

 

Basket examination

(Examine at time of use)

None

None

None

None

No gross defects as determined by visual inspection

No gross defects as determined by visual inspection

Paddle examination (inspect at time of receipt only)

None

None

None

None

No gross defects as determined by visual inspection

No gross defects as determined by visual inspection

Shaft wobble Shafts w/o baskets attached and paddle shafts

 

No significant Wobble

None

No significant Wobble

No significant Wobble

< 0.5 mm total runout

< 0.5 mm total runout

Basket wobble

 

+ 1 mm

None

None

None

< 1.0 mm total runout

< 1.0 mm total runout

Vessel/Shaft Centering

NMT 2 mm at any point from vertical axis of vessel.

NMT 2 mm at any point from vertical axis of vessel.

NMT 2 mm at any point from vertical axis of vessel.

NMT 2 mm at any point from vertical axis of vessel.

2 mm from centerline

1 mm from centerline

Height check/ Basket Depth and Paddle Depth

25 + 2 mm

25 + 2 mm

25 + 2 mm

25 + 2 mm

25 + 2 mm

25 + 1 mm

 

Vibration

 

No significant Vibration

No significant Vibration

No significant Vibration

No significant Vibration

< 0.2 mil displacement

< 0.1 mil displacement

Rotational speed

 

+ 4%

+ 4%

+ 4%

+ 4%

+ 2 rpm

+ 1 rpm

 

Vessel temperature

(Measure at time of use)

37 + 0.5 C

37 + 0.5 C

37 + 0.5 C

37 + 0.5 C

37 + 0.5 C

37 + 0.5 C