E-706

Pre-screening Bulk and Tapped Density of Key Materials

Section E — Materials Management Revision 1 5 pages

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1.0 Purpose
This procedure outlines a pre-screening system for critical density materials and provides and
early warning system to identify materials lots which could affect the processability of
formulas/products. This procedure also provides instructions for performing the testing
necessary to identify critical density material lots through bulk and tapped density
measurements.
2.0 Scope
This procedure applies to key raw materials that affect the processability of products
manufactured by Ion Labs, Inc.

3.0 Responsibility

3.1 It is the responsibility of R&D to follow this procedure. R&D must document
acceptable bulk and tapped density ranges on the NPA and ensure RM Profiles are
updated during sign- off. R&D will also determine if a raw material can be used
through planned deviation should it fall outside of the acceptable ranges.

3.2 It is the responsibility of QC Laboratory to follow this procedure. QC Laboratory will
conduct the bulk and tapped density test on all critical density raw materials and will

alert the QS Manager and R&D Manager when materials are out of range.
3.3. It is the responsibility of QC Laboratory personnel to quarantine unacceptable materials

and coordinate with Purchasing for the return of unacceptable materials.

4.0 Definitions

4.1 Bulk Density — the density of a powder “as poured” or passively filled into a measuring
vessel

4.2 Tapped Density — density attained after “tapping down” a powder

4.3. QC - Quality Control

44 QS- Quality Systems

4.5 R&D — Research and Development

[SOP

Standard Operatii ng Procedure SaOP0 No | Re| v | Page 2 of 4
Pre-Screening Bulk and Tapped Density of Key Materials

4.6 NPA — New Product Approval

4.7. RM Profile — A Raw Material Profile states the necessary specifications that a raw
material must be tested against and pass

5.0 References

51. E-706-F 1, Form, Bulk and Tapped Density Pre-Screening Form

5.2 E-801, SOP, Return of Materials and Destruction of Non-Hazardous Waste Materials

6.0 Procedure

6.1 NPA

6.1.1 R&D will create an NPA document which will include a section of all key
materials that have densities which affect the processability of products. The
NPA is shared with the QC Laboratory.

6.2 RM Profile

6.2.1 QC Laboratory personnel will create the RM Profile based on critical
specifications outlined in the NPA.

6.2.2 Bulk and Tapped density cannot be COA challenged and must be tested on
every lot.

6.3. Bulk Density

6.3.1 QC Laboratory Personnel will collect approximately 100 grams from containers
to represent the lot of received material.

6.3.2 Using Form E-706-F1 Bulk and Tapped Density Pre-Screening Form:

6.3.2.1 Pass the powder sample through a sieve to remove agglomerates.

6.3.2.2 Tare a 100ml] graduate cylinder of suitable dimensions for the AS-100
Tap Density Tester.

6.3.2.3. Gently transfer via a funnel sufficient powder to fill 50ml to 60ml of
the cylinder with minimal shaking or vibrations.

6.3.2.4 Record weight on Form E-706-F1.

6.3.2.5 Determine the volume by gently moving the graduated cylinder to
create a flat surface for accurate line to determine measured volume.
Using only whole numbers, record as volume (b) on Form E-706-F1.

6.3.2.6 Density is calculated using the following equation:

[SOP

Standard Operating Procedure SOP No | Rev
E-706 1 | Page3 of 4
Pre-Screening Bulk and Tapped Density of Key Materials

e Density = (a) weight (gm) / (b) volume (ml)
6.3.2.7 Compare the results with the acceptable ranges specified on the RM

Profile and determine if it has passed or failed. Record findings on
Form E-706-F1 and continue with tapped density testing.

6.4 Tapped Density

6.4.1 Utilizing the sample used to test the bulk density, fix the cylinder to the AS-100
Tap Density Tester and tap 1000 cycles at a distance of 3mm +/- 0.2mm
between 100-300rpm. This process should take about 5 minutes.

6.4.2 Measure and record the apparent volume of the powder on Form E-706-F1.

6.4.3 Density is calculated using the following equation:

6.4.3.1 Density = (c) weight (gm) / (d) volume (ml)

6.4.4 Compare the results with the acceptable ranges specified on the RM Profile and
determine if it has passed or failed. Record findings on Form E-706-F1 and
continue to notification step.

6.5 Notification

6.5.1 Pass - If the critical density material has a bulk and tapped density within the
acceptable ranges provided on the RM Profile.

6.5.1.1 QC Laboratory Supervisor will review results reported on Form E-706-
Fl.

6.5.1.2 Form E-706-F1 is added to Raw material testing packet be delivered to
Document Control to be scanned and filed.

65,2 Fail — if the critical density material has a bulk or tapped density that fall outside
of the acceptable ranges provided on the Raw Material Profile, QC Laboratory
must immediately notify R&D Manager via email or phone.

6.5.2.1 Form E-706-F1 will be forwarded to R&D after notification.

6.5.2.2 R&D will evaluate the material and determine if the material can be
used or should be returned.

6.5.2.3 If the material is to be returned:

e R&D/QC/Purchasing will follow SOP E-801 Return of Materials
and Destruction of Non-Hazardous Waste Materials to have the
material returned to the vendor.

[SOP

Standard Operating Procedure SOP No Rev
Pre-Screening Bulk and Tapped Density of Key Materials E-706 Page 4 of 4

e QC will ensure that the material is labeled appropriately and placed

in quarantine.
6.5.2.4 Ifthe material can be used:

e R&D will determine any changes that need to be made in order to
use the material (i.e. roller compaction, fill reduction, fill increase,
etc.)

e R&D will initiate a planned deviation to add processes and/or
make formula revisions in order to use the material.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/13/16 | New | 16-0424 | L. Titolo |
| 1 | 09/12/19 | Updated SOP to reflect current practice. Deleted reference to critical density material list and added RM Profile and NPA references. | 19-0663 | K. Westphal |

[SOP

iON Bulk and Tapped Density Pre-Screening Form
ST QUALITY FIRST Form: —E-706-F1 CCR No. 19-0663 Revision: 1

Raw Material Test Date: Time:

RMID: R# Customer Lot#

Bulk Density
Instructions: QC will collect approximately 100 grams from the lot of material to be tested.

Method:
e Tare a 100 ml graduated cylinder and gently transfer via a funnel sufficient powder to fill 50 ml to 60 ml

of powder with minimum shaking or vibrations.
e Weigh the net weight of powder transferred into 100 ml graduated cylinder, record as weight (a).
e Determine volume by gently moving graduated cylinder to create a flat surface for accurate line to
determine measured volume using only whole numbers, record as volume (b).

Calculations: Density = weight (gm) / volume (ml)

Acceptance Range: Acceptance Range attained from RM Profile Dated

Bulk Density Range Min g/ml Max g/ml

Results: Bulk Density
Sample a. Weight (gm) b. Volume (ml) Bulk Density (a / b) Pass / Fail
Bulk sample

Tapped Density

Method:
e Transfer the weight in Bulk Density section (a) to weight in Tapped Density section (c)
e Utilizing the sample used to test bulk density, Fix the cylinder to the AS-100 Tap Density Tester and tap
1000 cycles at a distance of 3mm +/- 0.2mm between 100-300 rpm. The process should take about 5
minutes.
e Determine volume by gently moving graduated cylinder to create a flat surface for accurate line to
determine measured volume using only whole numbers, record as volume (d).

Calculations: Density = weight (gm) / volume (ml)

Acceptance Range: - Acceptance Range attained from RM Profile Dated

Tapped Density Range Min g/ml Max g/ml

Results: Tapped Density
Sample c. Weight (gm) d. Volume (ml) Tapped Density (c / d) Pass / Fail

Tapped sample

*IF MATERIAL IS NOT WITHIN ACCEPTANCE RANGE, NOTIFY QC AND R&D IMMEDIATELY

Performed by: Date: