What is packaging?
Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use.
Importance of Packaging
To produce a pharmaceutical product with high quality standards and even it is more important to protect that product form the degradation, external contamination and other physical/chemical damages. For that choice of choosing packaging materials is challenging task for all food and drug industries.
- Protect against all adverse external influences that can alter the properties of the product.
- Protect against biological contamination.
- Protect against physical damage.
- Carry the correct information and identification of the product.
- Tamper evident / Child resistance/ Anti-counterfeiting.
Functions of packaging Material
Containment:
- Not to leak, nor allow diffusion and permeation.
- Strong enough to hold the contents during handling.
Protection:
- Light
- Moisture
- Oxygen
- Biological contamination
- Mechanical damage
- Counterfeiting
Material characteristics for Packaging Material
- It must preserve the physical properties of all dosage forms and protect them against damage or breakage.
- It must not alter the identity of the product.
- It must preserve the characteristics properties of the Product to comply specifications.
- It must protect product against undesirable or adulterating chemical, biological or physical entities
Roles of Packaging Material
Protecting the product from the environment and vice versa:
- Physical and chemical stability of the medicine (being an effective barrier to light, moisture, Oxygen, bacteria, volatiles, etc. as appropriate)
- Mechanical trauma – protection from damage During transit, distribution and storage of the product, maintaining product integrity until It’s in-use phase is completed or the expiry date stated on the label has passed.
Providing all necessary information for..
- Identification of the medicine (including strength)
- Safe preparation of the medicine if required (e.g. reconstitution, dilution)
- Safe use of the medicine (e.g. clearly worded instructions, pictograms) including precautions (Food/drug compatibilities and side effects)
- Storage and shelf-life of in-use product
- Appropriate disposal of any unused medicine and the packaging itself
Enabling accurate dosing and compliance
- Spoons, cups or syringes for oral dose measurement and delivery
- Dropper tubes for eye/ear/oral delivery of drops
- Applicators (e.g. pessaries)
- Dispensing devices, actuators, pre-filled syringes
- Dose counting and calendar devices.
Ensuring supply-chain integrity of the medicine
- Pedigree and “Track-and-Trace” systems assuring “chain of custody”
- Anti-counterfeiting measures
- Counter-measures for illegal cross-border trading
Packaging Material & Types
Any Material, used for Packaging of Pharmaceutical or any Product for safe Delivery from Manufacturer to the end user, The main purpose is to protect from the Environment or Physical Damages.
Primary Packaging Material:
The Material that first envelops the product and holds it or the Package which is in direct contact with the content.
Example: PVC/ PVDC, Blister foil, Closures, HDPE bottles, Tubes for Ointments Etc.
Secondary Packaging Material:
The Material used primarily to give additional physical protection to the outside of a proximity package and aiding to customer convenience and Information.
Example: Cartons, Inserts, Labels etc.
Tertiary Packaging Material:
The Material used for Transportation which also aids in handling and prevent damages to the product.
Example: Shippers, HDPE drums, wooden pallets etc.