QUALITY ASSURANCE & QUALITY CONTROL

Packaging Material Quality Control

A. TEST FOR GLASSPackaging Material Quality Control - Limit: NMT 10% at any wavelength in
the range of 290 to 450nm
Hydrolytic Resistance - old USP tests
• Arsenic
a. Powder glass test
- For Type I and Type II glass container
Sample: crushed Type I and Type III glass - Method: same with limit test for As
Method: acid-base titration with 0.2 N H2SO4 - Limit: NMT 0.1 microgram

Indicator: Methyl red

GLASS LIMIT TEST (mL of 0.02
b. Water attack test TYPE H2SO4
I 1.0
Sample: infer surface of Type II glass II 8.5
Method: acid-base titration with 0.2 N H2SO4
B. TEST FOR PLASTICS
Indicator: Methyl red
 Biological reactivity test in Vivo
c. Surface glass test
 Biological reactivity test in Vitro
Sample: inner surface of Type I and Type III
glass
FINISHED PRODUCT QUALITY CONTROL
Method: acid-base titration with 0,1 N HCL
A. FPQC TEST FOR TABLETS
Indicator: methyl Red
• Friability
TYPE DESCRIPTION TYPE OF
TEST • Dosage unit uniformity
I Highly-resistant Powdered • Disintegration
borosilicate glass glass
Surface glass • Dissolution
II Treated soda-lime Water attack
glass FRIABILITY
III Soda-lime glass Powdered
glass - Primary importance: No capping or
Surface glass chirping
- Equipment: Roche/Vanderkaamp
friabilator
NEW USP TESTS
- Specifications: 25rpm x 4mins = 100
• Light transmission rev.

- For colored glass containers DOSAGE UNIT UNIFORMITY

Averag Acceptance
 QUALITY ASSURANCE & QUALITY CONTROL

Packaging Material Quality Control

e Packaging Material Quality Control

criteria ◾Surface Glass Test – used to distinguish
weight Max Type I and Type II glass containers from Type
difference III glass container. It is based on hydrolytic
<130m 10% NMT 2 units resistance of the inner surfaces of glass
g are outside AC containers.
130mg 7.5%
–
324mg
>324m 5% No unit is ◾Surface Etching Test/Comparison of Glass
g outside twice Grains Test and Surface Glass Test data – this
the AC
is to determine whether high hydrolytic
resistance of Type I or Type II glass
Leaching containers are due to inner surface
treatment or due to the chemical
- is a process of mass transfer that composition of the glass containers
occurs by extracting a substance
from a solid material that has come
into contact with a liquid.
Test for plastics

In vivo test
Type 1
- are required in certain instances (such as
-use for buffered and unbuffered aqueous USP 88 class VI plastics) to determine the
materials systemic biological reactivity of mammalian
cells to contact with elastomeric plastics and
other polymeric materials.

Type 2 ◾systemic injection test- used for parenterals

containers test
-acidic and neutral aqueous parenterals
- albino mice

◾intracutaneous test- parenteral containers

Type 3
also but the only difference is the animal use
-non-aqueous and dry solid parenterals
- albino rabbits
Hydrolytic resistance test (old usp test)
◾eye irritation test - opthalmic containers
Test for glass containers
-albinu rabbits

◾implantation test- material in direct contact

◾Glass Grains test – used to distinguish Type with tissues
I glass from Type II and Type III glass
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-rabbits ◾disintegration - we have the measure of the

time required for a tablet to break up into
small particles
In vitro test Layman's term: Pila ka mins or hours aysa
- are required to determine the biological ma-disintegrate ang tablet/s by the use of
reactivity of mammalian cells to contact with water or HCl
elastomeric plastics and other polymeric
materials.
◾dissolution test- it is for measuring the
⚫agar diffusion test amount of time required for given
⚫direct contact test percentage of drug substance in a tablet to
grow in the solution
⚫Elution test

Same sample use: elastometric materials

Organism:Cells/tissue

FPQC

- are used to common old dosage forms for

identifications, assays in the ph

◾Friability - test used to determine the

tablets durability

*Insert formula

◾dosage unit uniformity - ensures the tablet

meets the specifications for potency

🟦We have this kind of test because of the

uneven distribution of the API in powdered
mixture granulations ,the segregation of
powdered mix and tablet weight variation
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