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III.

RESULT AND DISCUSSION test, uniformity content test, pH test,


In this sterile pharmaceutical practice, stability test, and sterility test, floating
this study discusses a trial of making KCl test, burning test, fall resistance test,
infusion. Intravenous infusion is a sterile scratching test, elasticity test. Leak test is
preparation of a solution or emulsion, done by placing infusion in the dyestuff
pyrogen free and as much as possible (methylene blue 0.5-1%) in the vessel.
isotonic to the blood, injected directly into Subsequent atmospheric pressure then
the vein in a relatively large volume. The causes the dye penetrate into the hole,
0.15% KCl infusion to be manufactured visible after the outside of the ampoule
includes the type of electrolyte infusion and vials are washed to clear the color
used to treat hypokalemia or overcome the substance. If there is a leak then it will
difference in ions or deviations from the change the color to blue and the packer is
number of normal electrolytes in the not passed leak test.
blood. The infusion formula made must be The pH test is performed by checking
eligible, among others, safe and should not the pH of the solution using pH. If using a
cause tissue irritation and toxic effects, pH meter before use, check the electrodes
clear no solid particles, colorless unless it and bridges of salt. Calibration of pH
is colored, as far as possible isohidris, meter by rinsing electrode and cell several
isotonis, should be sterile, and pyrogen times with test solution and cell contents
free. The following formula of the drip with little test solution is read pH value.
preparations made can be seen in Table. 1 Use CO2 free water for dissolution by
®
Table 1. Formula of KALVIT Infusion dilution of the test solution. The clarity
Formula Composition test in which a visual inspection is usually
KCl 0.15% performed by a person examining a clean
NaCl 3.9 gram container from the outside under good
WFI Ad 500 mL
light illumination, is blocked from
reflection into his eyes, and a black and
NaCl in the formula is used as a regulator white background, with a series of
for isotonic tonicity with body fluids, whereas contents executed by a spin action,
WFI is used as carrier solution. There are
completely free of tiny particles that can
several quality control tests for infusion
be seen with the eye.
preparation performed such as leaker test,
The volume uniformity test is
volume uniformity test, weight uniformity
performed by looking at the 500 mL limit
test, pyrogenicity test, clarity test, volume
shown on the infuse bottle. The sterility
test selected for the quality control of this time, under the influence of environmental
dosage preparation is a direct inoculation factors such as temperature, humidity, and
method into the agar medium. Specific light. the stability test performed at this lab
volumes of specimens plus a specified is done at various temperatures ie the
volume of test media incubate at 37oC for temperature of the refrigerator and the
24 hours to see if bacteria exist or not, temperature of the incubator. Scratching
whereas for mold or yeast is incubated for test is done by scraping the nails on the
5 days, then observe visually the presence packaging. The fall resistance test is
or absence of colonies. The selected carried out by dropping the container
pyrogensity test for testing the quality of containing the dosage from a height of 75
the injection dosage form is the rabbit test cm, the purpose of this test to see how
method which is based on an increase in strong the packaging resistance is in
body temperature of the rabbit injected protecting the preparation against physical
with a solution of ≤ 10 mg/kgBB of and mechanical collisions.
bacteria in the auricular vein. But cause 3.1 Clarity Test
difficult to get a rabbit then the practicum A visual examination is usually
this time used white rats or mice with the performed by someone who checks the
condition that no rabbit or mouse showed cleaner from the outside under good
a rise in temperature of 0.6ºC or more. If lighting, is blocked from reflection into his
there are rabbits or rats with a rise in eyes, and a black and white background,
temperature of 0.6ºC or more, continue with a series of contents executed by a
with additional rabbits or mice. spin action, must be completely free from
Uniformity content using titration of small particles that can be seen with the
argentometry. Made a standard curve eyes. The result of clarity test show can be
using several series of actors with a storied seen in Table. 2

ppm concentration. The stability of a drug Table 1. Result of analysis clarity test

is the ability of a product to retain its Replication Result

properties and characteristics to be equal 1 Clear

to that it possesses when it is made 2 Clear

(identity, strength, quality, purity) within 3 Clear

the limits set during the storage and shelf- Requirement : Clear and no floating particle

life periods. This stability test aims to The clarity test is performed to ensure
prove how the quality of the active clear and free preparation of drifting
ingredient or drug product changes over particles which can be derived from filter
material, primer packers not yet clean, or 3.4 Sterility test
during formulation process. Testing is Table 5. Result of sterility test

usually done by observing the dye under a Media Colony

lamp with a dark background. If there is a NA 0


floating particle and a cloudy solution, PDA 0
reformulation and preparations are not
feasible to use. Based on the observations
In this test was done using 2 media, namely
of the infuse qualify and pass the test of
NA and PDA media, where NA for bacteria
clarity because no particles floating.
and PDA for mushrooms with different
3.2 pH Test
temperature, at NA temperature 35-37OC and
The result of pH test of preparation
PDA 20-25OC from this test obtained ALT
injectable show can be seen in Table. 3
value of media NA not found bacterial colony
Table 3. Result of analysis pH test
while PDA media 0 or not found. It was
Replication pH
therefore concluded all preparations
1 6 infusion that pass the sterility test, which
2 6
means innfusion is sterile.
3 6
3.5 Uniformity content test
Requirement : pH 5-7 Table 6. Result of uniformity content test
Based on the results of testing that has been Replication Content of vial
done, it can be concluded that the infusion the 1 93.5%
pH of the well where they meet the 2 96%
requirements pH.
3 96%
3.3 Leaker Test
Requirement : if the active substance >50
The result of the test of leak test of infusion
mg then should not deviate from the range
of complete show can be seen in Table 4.
90-110%.
Table 4. Result Leaker Test
The preparation meets the uniformity
Replication Result
substance because it does not exit the
1 Not leaking
2 Not leaking required range of more than 50 mg.
3 Not leaking 3.6 Volume Uniformity Test

Requirement : not leaking (no change of Table 7. Result of volume uniformity test

color) Replication Volume (mL)

Based on the results of testing that has been 1 500.1

done, can it can be concluded that the 2 500.1


3 500.1
packaging passed the leak test.
Requirement : %CV < 5% rise test in rat test animal. From the
The volume uniformity test is observation results obtained for infusion
performed to ensure the preparation has a according to the requirements for
slightly more volume than the volume in temperature increases intervals of less than
the etiquette. Based on the results of testing 0.6 o C.
that has been done, then it can be know if 3.9 Uniformity Weight Test
infusion KCl 0.15% has a good volume or Table 10. Result of uniformity weight test
uniform. The average volume injection dosage Replication
is 500.1, a standard deviation of and %CV 1 530.29 g
%. 2 530.29 g
3.7 Stability Test 3 530.29 g
Table 8. Result of stability test Requirement :
Replication Refrigator Incubator  <120-300 mg should not deviate from
temperature temperature 10%
1 Stable (no Stable (no  120-300 mg should not deviate from
2 change in the change in the 7.8%
3 preparation) preparation)
 >120-300 mg should not deviate from
Requirement : Stable (no change in the 5%
preparation) Based on the results of the uniformity of
Based on the observation results weights, we can conclude that the average
obtained infusion in stable various weight of infusion is 530.29 grams, and a

conditions and temperatures. standard deviation of %CV is %. For

3.8 Pirogenicity Test weight on etiquette >120-300 mg


Table 9. Result of pirogenicity test deviation should not exceed 5%, for
Replication Temperature Average weight on etiquette >300 mg deviation
initial (oC) temperature should not exceed 5%.
for 3 hours 3.10 Floating Test
(oC)
Table 11. Result of floating test
Replication 1 34.9 35
Replication Result
Replication 2 35 35.2
1 floating
Replication 3 35.1 35.2
2 floating
Requirement : should not one rat rise in
3 floating
temperature > 0.6 C. o
Requirement : floating
The pyrogenicity test in this research
was done by the method of temperature
An empty package is immersed in a vessel height of 75 cm, the test results showed that as
filled with water, performed as much as three many as three replication packs passed the test
replications showing the result of a float pack. of fall resistance. this is indicated by no
3.11 Burning Test leakage on the packaging after dropping from
Table 12. Result of burning test a height of 75 cm.
Replication Result 3.14 Elasticity Test
1 Thermostable Table 15. Result of elasticity test
2 Thermostable Replication Result
3 Thermostable 1 Elastic

Requirement : Thermostable 2 Elastic

Burning test was performed on the 3 Elastic

packaging for three replications and the results Requirement : Elastic


showed that the packaging was resistant to The test results show that the packing with
heat after being burned for some time. the test as much as three times the replication
3.12 Scratching Test proved elastic.
Table 13. Result of scratching test Results of Data Analysis
Replication Result Normality test
1 No scratches Tests of Normalityb
2 No scratches
Kolmogorov- Shapiro-
3 No scratches
Smirnova Wilk
Requirement : No scratches
Stati Sig Stati Sig
After the scratching test by scraping the stic df . stic df .
nails on the packaging as much as three
replication results obtained that the packaging Uji_Keserag 3 .25
is resistant to scratches, this is indicated in the aman_Kadar .337 3 . .855 3
absence of scratches on the packaging. Uji_Keserag 3 . 3 .52
.385 .750
3.13 Fall Resistance Test aman_Bobot 0
Table 14. Result of fall resistance test
Replication Result Data analysis was performed with SPSS on
1 Hold down test of uniformity of content and weight
2 Hold down
uniformity test. In analysis uniformity of
3 Hold down
content and and weight uniformity test
Requirement : hold down (resistant to
obtained normality value above 0.05 Then it
falling)
can be concluded that the data is distributed
Fall resistance test is done by dropping the
evenly.
container containing the preparation from a
IV. CONCLUSION Based on the observation results
The infusion is a sterile preparation of a
obtained infusion in stable various
solution or emulsion, pyrogen free and as
conditions and temperatures. The
much as possible isotonic to the blood,
preparation has uniformity of content with
injected directly into the vein in a relatively
percentage of 96% level, volume volume
large volume. The 0.15% KCl infusion to
as it obtained% CV <5%, fulfilling weight
be manufactured includes the type of
uniformity test because no deviation of
electrolyte infusion used to treat
more than 5%. The packaging also shows
hypokalemia or overcome the difference in
resistance to heat, pass beret test, fall
ions or deviations from the number of
resistance and other quality control tests.
normal electrolytes in the blood. There are
Sediian infusion of 0.15% KCl indicates
several quality control tests for infusion
that it meets minimum standards of quality
preparation performed such as leaker test,
preparations.
volume uniformity test, weight uniformity
test, pyrogenicity test, clarity test, volume
test, uniformity content test, pH test,
stability test, and sterility test, floating
test, burning test, fall resistance test,
scratching test, elasticity test.
Based on the observations of the infuse
qualify and pass the test of clarity because
no particles floating. Based on the results of
testing that has been done, it can be concluded
that the infusion pH infusion 6 and similar to
the pH of body fluids or blood. Based on the
results of testing that has been done, can it can
be concluded that the packaging passed the
leak test. based on test results using direct
inoculation method on NA and PDA media
known that sterile preparations are free from
microorganisms. So, also on the pyrogensity
test showed there is not a single mouse that
experienced a temperature rise of 0.6oC means
that free from pyrogen.