EXPERIMENT 10

MOISTURE PERMEATION
QC2 LABORATORY
PACKAGING MATERIALS
• PRIMARY PACKAGING
may become or in direct contact with the product
primary role in maintaining product quality

• SECONDARY PACKAGING
not and will not be in direct contact with the product
may provide additional protection
ENVIRONMENTAL FACTORS
• TEMPERATURE
labels show appropriate storage condition
• MOISTURE and HUMIDITY
• LIGHT
prevents photodegradation
• GASES and VOLATILE MATERIALS
PACKAGING MATERIALS
• GLASS
• METALS
• RUBBERS
• PLASTICS
• FIBROUS MATERIALS
• FOILS, FILMS AND LAMINATES
MOISTURE PERMEATION
• Determination of the ability of the container to protect its contents

• Specimen: 12 bottles
10 test containers with dessicant CaCl2
2 bottles with glass beads (control)

• Stored 14 days = 23±20, 75±3% RH

• 35g NaCl in 100 mL water
MOISTURE PERMEATION

(1000/14V) [(Tf – Ti) – (Cf – Ci)]

Where:
• V = the mean volume of the containers in mL
• (Tf – Ti) = difference in mg, of the final and initial weights of the test
containers
• (Cf – Ci) = average of the differences in mg, of the 2 controls
MOISTURE PERMEATION
• Tight container
– nmt 1 of 10 containers is > 100mg/day/L,
none > 200mg/day/L

• Well-closed container
– nmt 1 of 10 containers is > 2000mg/day/L,
none > 3000 mg/day/L
MOISTURE PERMEATION
• OFFICIAL STORAGE CONDITION
Freezer -20 to -10°C
Cold nmt 8°C
Refrigerator 2 to 8°C
Cool 8 to 15°C
Room Temperature Prevailing
Controlled Rm Temp 15 to 30°C
Warm 30-40°C
Excessive Heat >40°C
 EXPERIMENT 11
VALIDATION
QC2 LABORATORY
VALIDATION

• defined as the verification, by data and analysis, that the design

objectives of a given facility, system, apparatus, or procedure are
reliably fulfilled in routine operation
VALIDATED PRODUCT

• one that has shown by appropriate scientific means to be uniform

within a lot, consistent between lots, and meeting design criteria
within defined limits
STEPS IN VALIDATION

1. Choosing the desired attributes of the product

2. Determining specifications for those attributes
3. Selecting the appropriate processes and equipments
4. Monitoring and testing processes, equipment and personnel while
in operation
5. Examining test procedures themselves to ensure their accuracy and
reliability
SCOPE: PROCESS VALIDATION

• Gathering and documenting of sufficient evidence to give reasonable

assurance that the process under review does what it is expected to
do

• Ex. Blending, granulation, compression, coating

SCOPE
ASSAY VALIDATION
• Important in evaluation of stability and establishments of expiry dates

FACILITY or EQUIPMENT VALIDATION

• Utilities, model of equipments, sanitation, maintenance

VALIDATION OF EXISTING PRODUCTS BY STATISTICAL EVALUATION

• Graphical presentation and Quantitative techniques
SCOPE
CLEANING VALIDATION
• Concern is for residual contaminants which could alter subsequent
products

POST-VALIDATION
• When there is change in formulation, processing condition, cleaning
procedures
VALIDATION
• Acceptance criteria
• MEAN ± 3SD

• Standard deviation
• Get the mean weight
• Subtract the mean from the individual weight then get the square
• Get the mean of the squared differences
• Get the square root