B-602

Rx-4 Automatic Tablet Capsule Counter

Section B — Manufacturing Revision 0 4 pages

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1.0 Purpose

This procedure defines the operation, cleaning, and troubleshooting of the Rx-4 Automatic
Tablet and Capsule Counter in use at Ion Labs, Inc.

2.0 Scope

This procedure only applies to the Rx-4 Automatic Tablet and Capsule Counter used during

packaging operations at Ion Labs, Inc.

3.0 Responsibility

3.1 ‘It is the responsibility of Production and QC personnel to follow this procedure.
Production and QC personnel are responsible for performing bottle count verifications

during the packaging process.

3.2 It is the responsibility of Production personnel to adequately clean the Rx-4
tablet/capsule counter as a part of normal room cleaning procedure.

3.3. ‘It is the responsibility of QC personnel to ensure that the Rx-4 tablet/capsule counter
has been cleaned and properly documented as a part of normal room cleaning

procedure.

3.4 It is the responsibility of the department supervisor/manager to implement this
procedure and to ensure that the procedure is followed.

4.0 Definitions

4.1 QC - Quality Control

5.0 References

Ss B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment

[SOP

Standard Operating Procedure SOPNo Rev
Rx-4 Automatic Tablet/Capsule Counter B-602 0 Page 2 of4

6.0 Procedure

6.1 Operation

6.1.1 Turn machine on.

6.1.2 Be certain that the collection trays are properly inserted.

6.1.3 Pour pills onto turntable disc. Eliminate stacked pills.

6.1.4 Adjust the separator tab.

6.1.4.1 Pointed end UP for capsules,

6.1.4.2 Pointed end approximately the height of the pill for flat and small
SIZES.

6.1.5 Select Mode using the Key Pad.

6.1.5.1 Single Mode (SGL) — used for counting a desired quantity of pills that

will dispense into the top collection tray. When the top tray is
removed, excess pills will drop into the bottom tray. Do not use the
vial drawer in Single Mode.

6.1.5.2 Multiple Mode (MULTI) — used when performing multiple counts of
the same quantity of the same pill. When the desired quantity is

dispensed, press START and the Rx-4 will count the same quantity
again. This can be done as many times as needed. To clear the
turntable after the last count, leave the top drawer out and press
CLEAR / INVENTORY / START.

6.1.5.3 Inventory Mode (INV) — used to count an entire quantity of pills. If the

count surpasses 999, the display will roll over to 000, 001, 002, etc.

6.1.6 Press START. The auto-gate will automatically open to adjust for pill size and
shape.

6.2 Using the Vial Drawer

6.2.1 The vial drawer enables rapid, direct filling of vials.

6.2.2. Remove both collection drawers and insert the vial drawer into the upper drawer
slot.

[SOP

Standard Operating Procedure SOPNo Rev
Rx-4 Automatic Tablet/Capsule Counter B-602 0-7 | ees ond

6.2.3 Insert the vial onto the dispensing tube. The vial retaining tab will hold the vial
firmly in place. For large vials, inset all the way onto the dispensing tube. For
small vials, insert into the open front of the dispensing tube.

6.2.4 Use the vial drawer only in multi or inventory count modes. Do not use the
funnel drawer in single mode.

6.2.5 If the vial drawer was used in single count mode, press STOP before removing
the drawer. To clear the turntable disc, replace the top drawer and press CLEAR
/INVENTORY / START.

6.3 Cleaning

6.3.1 Remove all product and paperwork from the previous batch.

6.3.2 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and
Equipment to follow the cleaning procedure applicable to this type of

equipment.
6.3.3 Document cleaning in the cleaning logbook.

6.3.4 Contact a QC inspector to verify equipment cleanliness and to check the
cleaning logbook.

6.3.5 Specific cleaning activities for this piece of equipment are as follows:

6.3.5.1 Turn off the power to the counter.

6.3.5.2 Tilt back the auto-gate assembly.

6.3.5.3 Remove any powder build-up from the bottom of the gate.

6.3.5.4 Remove and clean the sensor cover.

6.3.5.5 Remove and clean the sorting wheel.

6.3.5.6 Remove and clean the turntable disc.

6.3.5.7 The discs and plastic parts may be cleaned with a lint-free damp cloth.
Always clean both the top and bottom of the removed parts. Drawers

should be cleaned often to avoid contamination. Before replacing,
ensure that all parts are dry.

[SOP

Standard Operating Procedure SOP No Rev
B-602 Page 4 of 4
Rx-4 Automatic Tablet/Capsule Counter

6.4 Troubleshooting

6.4.1 If the pills are dispensed but the unit does not count, does not count properly,
counts by itself, the sensor signal lamp stays on, or the automatic gate will not
open:

6.4.1.1 Turn off the power.

6.4.1.2 Locate the sensor area in the font-left corner of the top of the unit. The
sensor is located in the square hole ringed by black plastic. The sensor
consists of two sets of glass eyes affixed under the black plastic in the
front and rear of the hole.

6.4.1.3. Using and alcohol-dampened cloth or wipe (do not use a cotton ball or

swab), gently scrub both sets of glass eyes in a horizontal manner.
Scrubbing in a vertical motion can misalign the sensor eyes.

6.4.1.4 Visually inspect the sensor hole to ensure that there are no other hard-
to-see items such as a fiber or hair obstructing the area between the
sets of glass eyes.

6.4.1.5 Reassemble the unit and resume counting.

6.4.2 If there is no power to the unit:

6.4.2.1 Check the power cord to ensure that it is firmly inserted into a
working, grounded AC outlet.

6.4.2.2 Check the fuse in the rear of the unit. Replace with 1 amp fuse only.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/01/21 | New procedure. N/A K. Burris | - | - |