**Calibration Criteria**

**CHEMICAL CALIBRATION / CALIBRATOR TABLETS**

+---------+---------+---------+---------+---------+---------+---------+
|         | **USP** | **JP**  | **BP**  | **EP**  | **      | **FD    |
|         |         |         |         |         | PhRMA** | A/DPA** |
+---------+---------+---------+---------+---------+---------+---------+
| Cal     | 6 Non   | None    | None    | None    |         | In      |
| ibrator | D       |         |         |         |         | House   |
| Tablets | isinteg |         |         |         |         | Cal     |
|         | rating, |         |         |         |         | ibrator |
|         | App. 1  |         |         |         |         |         |
|         |         |         |         |         |         |         |
|         | 6 Non   |         |         |         |         |         |
|         | D       |         |         |         |         |         |
|         | isinteg |         |         |         |         |         |
|         | rating, |         |         |         |         |         |
|         | App.2   |         |         |         |         |         |
|         |         |         |         |         |         |         |
|         | 6       |         |         |         |         |         |
|         | D       |         |         |         |         |         |
|         | isinteg |         |         |         |         |         |
|         | rating, |         |         |         |         |         |
|         | App.1   |         |         |         |         |         |
|         |         |         |         |         |         |         |
|         | 6       |         |         |         |         |         |
|         | D       |         |         |         |         |         |
|         | isinteg |         |         |         |         |         |
|         | rating, |         |         |         |         |         |
|         | App 2   |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+

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

+---------+---------+---------+---------+---------+---------+---------+
| **Cali  | **USP** | **JP**  | **BP**  | **EP**  | **PhRMA | **DPA** |
| bration |         |         |         |         | Pro     |         |
| Para    |         |         |         |         | posed** |         |
| meter** |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Vessel  | I       | I       | I       | I       | Same as | Same as |
| dim     | nternal | nternal | nternal | nternal | USP     | USP     |
| ensions | d       | d       | d       | d       |         |         |
|         | iameter | iameter | iameter | iameter |         |         |
| (       | 98-106  | 98-106  | 98-106  | 98-106  |         |         |
| Inspect | mm      | mm      | mm      | mm      |         |         |
| at time |         |         |         |         |         |         |
| of      | E       | I       | I       | I       |         |         |
| receipt | xternal | nternal | nternal | nternal |         |         |
|         | Height  | height  | height  | height  |         |         |
| only)   | 16      | 160-175 | 160-176 | 160-176 |         |         |
|         | 0-210mm | mm      | mm      | mm      |         |         |
|         |         |         |         |         |         |         |
|         | Hemisp  | Round   | Hemisp  | Hemisp  |         |         |
|         | herical | bottom, | herical | herical |         |         |
|         | bottom, | 1000ml  | bottom, | bottom, |         |         |
|         | 1000ml  |         | 1000ml  | 1000ml  |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Basket  | C       | C       | Same as | C       | Same as | Same as |
| dim     | onforms | onforms | EU      | onforms | USP     | USP     |
| ensions | to      | to      |         | to      |         |         |
| (       | diagram | diagram |         | diagram |         |         |
| Inspect | in USP  | in JP   |         | in EU   |         |         |
| at time |         | (Almost |         | (Almost |         |         |
| of      | Mesh    | id      |         | id      |         |         |
| receipt | Size    | entical |         | entical |         |         |
| only)   | 0.40    | to USP) |         | to USP) |         |         |
|         | +/-     |         |         |         |         |         |
|         | 0.04mm  | Mesh    |         | Mesh    |         |         |
|         |         | Size    |         | Size    |         |         |
|         |         | 0.425mm |         | 0.381mm |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Paddle  | C       | C       | Same as | C       | Same as | Same as |
| dim     | onforms | onforms | EU      | onforms | USP     | USP     |
| ensions | to      | to      |         | to      |         |         |
| (       | diagram | diagram |         | diagram |         |         |
| Inspect | in USP  | in JP   |         | in EU   |         |         |
| at time |         | (Same   |         | (Almost |         |         |
| of      |         | as USP) |         | id      |         |         |
| receipt |         |         |         | entical |         |         |
| only)   |         |         |         | to USP) |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Visual  | None    | None    | None    | None    | Belts   | Belts   |
| ins     |         |         |         |         | are     | are     |
| pection |         |         |         |         | tight,  | tight,  |
| of      |         |         |         |         | clean   | clean   |
|         |         |         |         |         | free of | free of |
| belts,  |         |         |         |         | cracks, | cracks, |
| check   |         |         |         |         | p       | p       |
| ball    |         |         |         |         | roperly | roperly |
| b       |         |         |         |         | a       | a       |
| earings |         |         |         |         | ligned, | ligned, |
|         |         |         |         |         | shafts  | shafts  |
|         |         |         |         |         | turn    | turn    |
|         |         |         |         |         | freely  | freely  |
+---------+---------+---------+---------+---------+---------+---------+
| Bath    | None    | None    | None    | None    | Level   | Bubble  |
| le      |         |         |         |         |         | within  |
| velness |         |         |         |         |         | lines   |
|         |         |         |         |         |         | of a    |
|         |         |         |         |         |         | bubble  |
|         |         |         |         |         |         | level   |
+---------+---------+---------+---------+---------+---------+---------+
| Shaft   | None    | None    | None    | None    | V       | Bubble  |
| vert    |         |         |         |         | ertical | within  |
| icality |         |         |         |         | as      | lines   |
|         |         |         |         |         | m       | of a    |
|         |         |         |         |         | easured | bubble  |
|         |         |         |         |         | by a    | level   |
|         |         |         |         |         | bubble  |         |
|         |         |         |         |         | level   |         |
+---------+---------+---------+---------+---------+---------+---------+
| Basket  | None    | None    | None    | None    | No      | No      |
| exam    |         |         |         |         | gross   | gross   |
| ination |         |         |         |         | defects | defects |
|         |         |         |         |         | as      | as      |
| (       |         |         |         |         | det     | det     |
| Examine |         |         |         |         | ermined | ermined |
| at time |         |         |         |         | by      | by      |
| of use) |         |         |         |         | visual  | visual  |
|         |         |         |         |         | ins     | ins     |
|         |         |         |         |         | pection | pection |
+---------+---------+---------+---------+---------+---------+---------+
| Paddle  | None    | None    | None    | None    | No      | No      |
| exam    |         |         |         |         | gross   | gross   |
| ination |         |         |         |         | defects | defects |
| (       |         |         |         |         | as      | as      |
| inspect |         |         |         |         | det     | det     |
| at time |         |         |         |         | ermined | ermined |
| of      |         |         |         |         | by      | by      |
| receipt |         |         |         |         | visual  | visual  |
| only)   |         |         |         |         | ins     | ins     |
|         |         |         |         |         | pection | pection |
+---------+---------+---------+---------+---------+---------+---------+
| Shaft   | No      | None    | No      | No      | [\      | [\      |
| wobble  | sign    |         | sign    | sign    | <]{.und | <]{.und |
| Shafts  | ificant |         | ificant | ificant | erline} | erline} |
| w/o     | Wobble  |         | Wobble  | Wobble  | 0.5 mm  | 0.5 mm  |
| baskets |         |         |         |         | total   | total   |
| a       |         |         |         |         | runout  | runout  |
| ttached |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| paddle  |         |         |         |         |         |         |
| shafts  |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Basket  | [       | None    | None    | None    | [\      | [\      |
| wobble  | +]{.und |         |         |         | <]{.und | <]{.und |
|         | erline} |         |         |         | erline} | erline} |
|         | 1 mm    |         |         |         | 1.0 mm  | 1.0 mm  |
|         |         |         |         |         | total   | total   |
|         |         |         |         |         | runout  | runout  |
+---------+---------+---------+---------+---------+---------+---------+
| Vesse   | NMT 2   | NMT 2   | NMT 2   | NMT 2   | 2 mm    | 1 mm    |
| l/Shaft | mm at   | mm at   | mm at   | mm at   | from    | from    |
| Ce      | any     | any     | any     | any     | cen     | cen     |
| ntering | point   | point   | point   | point   | terline | terline |
|         | from    | from    | from    | from    |         |         |
|         | v       | v       | v       | v       |         |         |
|         | ertical | ertical | ertical | ertical |         |         |
|         | axis of | axis of | axis of | axis of |         |         |
|         | vessel. | vessel. | vessel. | vessel. |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Height  | 25      | 25      | 25      | 25      | 25      | 25      |
| check/  | [       | [       | [       | [       | [       | [       |
| Basket  | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und |
| Depth   | erline} | erline} | erline} | erline} | erline} | erline} |
| and     | 2 mm    | 2 mm    | 2 mm    | 2 mm    | 2 mm    | 1 mm    |
| Paddle  |         |         |         |         |         |         |
| Depth   |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| Vi      | No      | No      | No      | No      | [\      | [\      |
| bration | sign    | sign    | sign    | sign    | <]{.und | <]{.und |
|         | ificant | ificant | ificant | ificant | erline} | erline} |
|         | Vi      | Vi      | Vi      | Vi      | 0.2 mil | 0.1 mil |
|         | bration | bration | bration | bration | displ   | displ   |
|         |         |         |         |         | acement | acement |
+---------+---------+---------+---------+---------+---------+---------+
| Rot     | [       | [       | [       | [       | [       | [       |
| ational | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und |
| speed   | erline} | erline} | erline} | erline} | erline} | erline} |
|         | 4%      | 4%      | 4%      | 4%      | 2 rpm   | 1 rpm   |
+---------+---------+---------+---------+---------+---------+---------+
| Vessel  | 37      | 37      | 37      | 37      | 37      | 37      |
| temp    | [       | [       | [       | [       | [       | [       |
| erature | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und | +]{.und |
|         | erline} | erline} | erline} | erline} | erline} | erline} |
| (       | 0.5° C  | 0.5° C  | 0.5° C  | 0.5° C  | 0.5° C  | 0.5° C  |
| Measure |         |         |         |         |         |         |
| at time |         |         |         |         |         |         |
| of use) |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+