Test Method

Bulk Density of Powder Dispersions at Time of Manufacture

Departments: Quality Control

I. Introduction:
This method is designed to assist Operations in determining optimal batch size for a specific blender and to
determine if requisite pack-out weight will fit in container. It will employ a single-use container or measuring
cylinder which are readily available at Colorcon. The sections below show how to standardize the container
and then perform the test. The approximate weight of water held in the chosen container should be at least
200 grams.

II. Definitions: Bulk Density: A measure of the volume a known weight of material occupies typically
expressed in g/cc.

III. Responsibilities: QC/TSL Analyst: The analyst is responsible for conducting the test according to this
procedure.

IV. Outline or Flow Chart: N/A

Version 3 effective on 30-Aug-2012

V. Equipment:

■ Container of known volume

■ Balance

VI. Safety Requirements: Consult MSDS for individual raw materials.

VII. Procedure:
Sampling:
Determination of Known Volume*:
1. Weigh 5 empty containers, chosen at random, on a top-load balance (accurate to ±0.01 grams), to
determine the tare weight of each container.
2. Completely fill these containers with 20-25°C purified water. Weigh each filled container.
3. Calculate weight of water in each container (step 2 wt. – tare wt.).
4. Determine average (Avg) and standard deviation (SD) of both the tare weights and water weights. The
ratio of SD to Avg for each cannot be more than 2%.
5. The average of the water weight results, meeting the criteria above, is now the “Known Volume”, in mL.
*A volumetric container can be used in place of this step

Page 1 of 3 Procedure Reference No.: GLO-QC-TM-1115, revision 3

Date Approved: 16-Aug-2012
Effective Date: 30-Aug-2012
Reviewed Date: September 2020
This document is valid at the time of distribution. Distributed automatically on 29-JUN-2022 (US EST)
 Bulk Density of Powder Dispersions at Time of Manufacture

Determination of Bulk Density:

1. Fill container with powder sample
2. Level off powder at the top of the container using a spatula
3. Weigh filled container, without lid and record result
4. Calculate sample weight (step 3 wt. – tare wt.)

5. Divide sample weight by “Known Volume” determined above

6. Bulk density result is in units of g/mL

Note: If using a graduated cylinder place a known weight of material into the cylinder and read off the volume
the material occupies. Where practical, the weight used should occupy as much of the cylinder possible.
Care should be taken when using either method not to compact the material as this will lead to an inaccurate
result.

VIII. Calculations:

Container volume
Water Weight = Filled WeightWater – Tare Weight

Water Weight1 + Water Weight2 + Water Weight3 + Water Weight4 + Water Weight5
Known Volume =
5
Bulk Density calculation
Sample Weight = Filled WeightSample – Tare Weight
Version 3 effective on 30-Aug-2012

Sample Weight
Bulk Density =
Known Volume

IX. Attachments: N/A

X. References:
■ Capability Study WP-2002-0249 – Determination of blender fills using Bulk Density
■ Doc No. 0665 Quick Reference Bulk Density Chart 8oz plastic retain jar

XI. Change History:

REVISION DATE COMMENTS
0 25-JUL-02 New Document Issue
1 26-JAN-04 Revised to apply globally (review meeting)
2 11-MAY-2009 Reformatted. Removed doc 0809 from references
3 06-JUL-2012 New document format

Page 2 of 3 Procedure Reference No.: GLO-QC-TM-1115, revision 3

Date Approved: 16-Aug-2012
Effective Date: 30-Aug-2012
Reviewed Date: September 2020
This document is valid at the time of distribution. Distributed automatically on 29-JUN-2022 (US EST)
 Bulk Density of Powder Dispersions at Time of Manufacture

XII. Approvers: (authorized signatures on file in the QA Department)

Version 3 effective on 30-Aug-2012

The information contained in this document is proprietary to Colorcon and may not be used or disseminated inappropriately.
Global Headquarters
Colorcon
275 Ruth Road, Harleysville, PA 19438
Tel: +1 215.256.7700 Fax: +1 215.256.7799 Website: www.colorcon.com
© BPSI Holdings LLC, 2020. All trademarks, except where noted, are property of BPSI Holdings LLC.

Page 3 of 3 Procedure Reference No.: GLO-QC-TM-1115, revision 3

Date Approved: 16-Aug-2012
Effective Date: 30-Aug-2012
Reviewed Date: September 2020
This document is valid at the time of distribution. Distributed automatically on 29-JUN-2022 (US EST)