Packaging suitability (Protection-compatibility-Safety - Performance)

Counterfeiting -Overpackaging -
Levels of Packaging (Primary Packaging -Secondary Packaging -Associated components)
Packaging Materials
Glass Containers (Composition of Glass -Manufacture of Glass)
Type I- Borosilicate -Glass Type II—Treated Soda-Lime - Glass Type III-Regular Soda-Lime- Glass
Type NP—General-Purpose Soda-Lime Glass).
Plastic Packaging Materials
Mechanical Properties: (Tensile strength- Impact strength -Tear strength -Stiffness -Coefficient of
friction -Blocking -Fatigue resistance -Creep failure)
Optical Properties: Light transmission- Clarity- Haze -Gloss
Electrical Properties
Drug-Plastic Considerations
(1)Permeation (2) Leaching (3) Sorption
Safety Testing
Classification of Plastic Packaging Materials
Thermoplastics -Thermosets-Additives
Polyethylene Terephthalate (PET ) (Characteristics – Application)
Polyethylene:
Low-density (LDPE) and High-density (HDPE) (Characteristics – Application)
Polypropylene (Characteristics – Application)
Polystyrene (PS) (Characteristics – Application)
Vinyl Plastics (Characteristics – Application)
Applications of Plastic Packaging Materials
A) Blister Packaging (heat-softened
( plastic film (thermoforming) - Lidding )
B) Strip and sachet packaging
C) Collapsible Tubes and Flexible Pouches (Metal tubes- Linings- Plastic tubes -Laminate squeeze
tubes)
D) Intravenous (IV) Solutions
CLOSURES
 Threaded Screw Cap
 Lug Cap
 Crown Caps

 Roll-On Closures
 Pilferproof Closures
 Child resistant cap
TAMPER-RESISTANT PACKAGING
Terminal sterilization
Pharmaceutical Cleanroom Classification
1) European Commission Guide to GMP of Sterile Medicinal Products
2) Food and Drug Administration (FDA) Guideline on Sterile Drug Products Produced by Aseptic
Processing.
Three Occupancy States: As Built -
• Operational (dynamically )-
• At Rest

Examples of Operations to Be Carried Out In the Various Grades of Clean Room( for
terminally sterilized products- for aseptic preparations)
Critical areas controlled areas
Flow Plan

HEPA filters -–

Laminar flow enclosures - Materials support area - Aseptic area

Entry and exiting

Airlock
Personnel training, qualification &monitoring
Gown for grade: D-C-A/B
Maintenance of clean rooms

Environmental control evaluation

1. Total particle count -

2. Microbial count - Locations for sampling
3. Pressure differential control

Media Fill (Process Simulation Testing)

Filling equipments
Sealing of ampoules
Blow/fill/seal (or form /fill/seal) technology