Particulate Matter in Injectables, USP Criteria

Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1

Document No: Title: Page No.
SOP/SL/009 Particulate Matter in Injectables, USP Criteria Page 1 of 6
Effective Date Revision Date
Particulate Matter in Injectables, USP Criteria
Prepared by： X X
Department Name Date
Approved by： Y Y
Authorized by： Z Z
1. Purpose
The purpose is to provide the USP criteria for the monitoring of liquid-borne particulate
matter in injections (large- and small-volume parenterals).
2. Scope
This procedure is applicable to - and small-volume parenteral in Humanwell

Pharmaceutical Ethiopia PLC
3. Validity
This SOP is valid only until next revision date and if it bears control seal.
4. Responsibility
Area QAI (quality assurance inspector, injections) is responsible for the monitoring of liquid-
borne particulate matter in the injection per the criteria mentioned in the SOP. The quality
assurance (QA) manager is responsible for SOP compliance
5. Material and Equipment

An electronic, liquid-borne particle-counting system that uses a light-obscuration sensor with
a suitable sample feeding device
6. Procedure
6.1. Test Environment
Perform the test in an environment that does not contribute any significant amount of
particulate matter. Specimens must be cleaned to the extent that any level of extraneous
particles added has a negligible effect on the outcome of the test. The test specimen,
glassware, closures, and other required equipment preferably are prepared in an
environment protected by high efficiency particulate air (HEPA) filters. Nonshedding
garments and powder-free gloves preferably are worn throughout the preparation of
samples.
Cleanse glassware, closures, and other required equipment, preferably by immersing and
scrubbing in warm, nonionic detergent solution. Rinse in flowing tap water and then rinse
again in flowing filtered water. Organic solvents may also be used to facilitate cleaning.
6.2. Test Preparation and Procedure
For containers having volumes of less than 25 ml, test a solution pool of ten or more units.
Single units of small-volume injections may be tested individually if the individual unit
volume is 25 ml or greater.
Prepare the test specimens in the following sequence. Remove outer closures, sealing
bands, and any loose or shedding paper labels. Rinse the exterior of containers with
filtered distilled water, as described under “Test Environment,” and dry, taking care to
protect the containers from environmental contamination. Withdraw the contents of the
containers in the normal or customary manner of use or as instructed in the package
labeling. However, containers with removable stoppers may be sampled directly by
removing the closure or, if test specimens are being pooled, by removing the closure and
emptying the contents into a clean container.
6.3. Procedure for Liquid fill (contents of each unit are less than 25 ml)
Mix each unit by inverting it 20 times to resuspend any particles. Open and combine the
contents of ten or more units in a cleaned container to obtain a volume of not less than 20
ml. Gently stir the contents of the container by hand-swirling or by mechanical means,
taking care not to introduce air bubbles or contamination. Withdraw not less than three
aliquot portions, each not less than 5 ml in volume, into the light obscuration counter sensor.
Obtain the particle counts and discard the data from the first portion.
6.4. Liquid fill (contents of each unit are 25 ml or more and option of testing individual
units is selected)
Mix one unit by inverting it 20 times. Remove the closure and insert the counter probe into
the center of the solution. Gently agitate the contents of the unit by hand-swirling or by
mechanical means. Withdraw not less than three aliquot portions, each not less than 5 ml
in volume, into the light obscuration counter sensor. Obtain the particle counts and discard
the data from the first portion.
6.5. Acceptance Criteria
For pooled samples (small-volume injections), average the counts from the two or more
aliquot portions analyzed. Calculate the number of particles in each container by the
formula
PVt /Va n
in which
P is the average particle count obtained from the portions analyzed
Vt is the volume of pooled sample, in milliliters
Va is the volume, in milliliters, of each portion analyzed
n is the number of containers pooled
For individual samples (small-volume injections), average the counts obtained for the 5-
ml or greater aliquot portions from each separate unit analyzed and calculate the number of
particles in each container by the formula
PV/Va
in which
P is the average particle count obtained from the portions analyzed
V is the volume, in milliliters, of the tested unit
Va is the volume, in milliliters, of each portion analyzed
See attachment no. 1700.40(B) for calculation and interpretation of results.

For individual unit samples (large-volume injections), average the counts obtained for
the two or more 5-ml aliquot portions taken from the solution unit. Calculate the number
of particles in each milliliter taken by the formula
P/V
in which
P is the average particle count for individual 5 ml or greater sample volume
V is the volume, in milliliters, of the portion taken
See attachment no. 1700.40(C) for calculation and interpretation of results.

6.6. Interpretation
The injection meets the requirements of the test if the average numbers of particles present
in the units tested do not exceed the appropriate value listed in Table 1.
Table 1 Light Obscuration Test Particle Count
≥10 μm ≥25 μm
Small-volume 6000 600 per container

injections
Large-volume 25 3 per milliliter

injections
6.7. RECORDS
 CoA for pooled sample/container
 CoA for individual sample/container
 CoA for individual sample/ml
7. Abbreviations
 SOP - Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History
Version
Revision Description
No.
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Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

Effective Date Revision Date

Effective Date Revision Date

This procedure is applicable to - and small-volume parenteral in Humanwell

5. Material and Equipment

Effective Date Revision Date

Effective Date Revision Date

6.5. Acceptance Criteria

See attachment no. 1700.40(B) for calculation and interpretation of results.

Effective Date Revision Date

See attachment no. 1700.40(C) for calculation and interpretation of results.

Table 1 Light Obscuration Test Particle Count

Small-volume 6000 600 per container

Large-volume 25 3 per milliliter

Effective Date Revision Date

 CoA for individual sample/ml

8. Related Documents /Applicable document/

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