What do you mean by pharmaceutical packaging?
Pharmaceutical packaging is an art and technology of enclosing or protecting pharmaceutical products for distribution, storage, sales, and use.
What are the types of pharmaceutical packaging material?
There are mainly three types of packing material –
- Primary packaging: is the material that carries the drug product.
- Secondary packaging: is outside of primary packing (i.e., inner cartoon).
- Tertiary packaging: used for bulk handling of dugs(i.e., shipper cartoon).
What are the objective of packaging?
The main purpose of drugs packaging is –
- Physical protection
- Barrier protection
- Security
- Patient convenience etc.
What are the primary Packing material used in blister pack?
- Lidding foil: aluminum foil, paper aluminum foil, glasin paper foil.
- Bottom foil: PVC (polyvinyl chloride) and PVDC (polyvinylidene chloride).
What is GSM? How to calculate GSM?
GSM means Gram per square meter, coating of PVC expressed in GSM, more GSM means more barrier property against moisture and gases.
GSM is calculated by – Weight of sample ✕ 1000/ area of the sample
What do you mean by WVTR and OTR?
- WVTR means - water vapor transmission Rate
- OTR means - oxygen transmission rate.
How do we overcome the lack of barrier properties of PVC?
To overcome this problem PVC can be coated with PVDC/ laminated to PCTFE (Polychlorotrifluoroethylene) or COC (Cyclic olefin copolymers) to increase protective properties.
Which machine parameters are critical during blistering?
- Forming temperature
- Sealing temperature,
- Cooling temperature,
- Machine speed.
What types of in-process test require for blistering?
- Blister appearance,
- Blister print (name, batch no., exp. date, mfg. license no.)
- Leakage test.
Which parameters are to be included in packaging material specification?
- The product name, strength, and reference code to be printed.
- The pack size and number of product items to be included in each pack, that is, the number of tablets, ampules, vials, etc.
- A description and reference of each packaging item to be included in the pack.
- Special precautions to be taken during the operation. For example the packaging of a moisture sensitive tablet may need to be performed under low humidity conditions.
- Detail the in-process control system to be operated. This will vary depending on the complexity of the packaging operations.
What are the critical parameters for setting standard packagingspecification?
- Appearance
- Dimensions
- Compatibility and costumer usability
- Chemical testing
What type of primary packaging material used in pharma industry?
- Ampoule
- Bag
- Blister
- Bottle
- Cartridge
- Injection syringe
- Pressurized container
- Tube
- Vial
What types of raw materials used in packaging?
- Cardboard
- Paper
- Glass
- Plastic
- Metal, e.g. aluminium
- Rubber
How to select packaging material for pharmaceutical product?
Based on Reference product packaging material and stability study at accelerated and long term condition.
Which type of packaging is suitable for moisture and light sensitive solid drug product?
Alu-Alu blister foil or HDPE container with proper sealing.