Q:1
Define pharmaceutical packaging.
Pharmaceutical packaging is a combination of various components which are required to contain, protect, preserve & deliver safe & efficacious drug products.
Q:2
What are the types of packaging?
3 types as,
- Primary Packaging
- Secondary Packaging
- Tertiary Packaging
Q:3
What is primary packaging?
The packaging which has direct contact with the product is known as primary packaging.
Q:4
What is secondary packaging?
The type of packaging which doesn’t have direct contact with the product and contains one or more primary packs is known as secondary packaging.
Q:5
What is Tertiary Packaging?
Tertiary packaging has no direct contact with the product and contains one or more secondary packs.
Q:6
Examples of Primary packaging?
The following are the most common examples of primary packing,
- Blister
- Strip
- Sachet
- Bottles
- Jars
- Ampules
- Vials
- Bags
- Droppers
- Capsule shells
- Collapsible tubes
Q:7
Give Examples of Secondary Packaging.
Following are common examples of secondary packaging
- Unit Cartons
- Boxes
- Ampule trays
- Blister wallet
Q:8
Give Examples of tertiary Packaging?
- Shippers
Q:9
What are the types of shippers?
The following are types of shippers,
- Insulated shippers
- Cold chain shippers
- Passive shippers
- Active shippers
- Dry ice shippers
Q:10
What is the purpose of pharmaceutical packaging?
Pharmaceutical packaging has the following benefits for the product,
It gives protection to the product from,
- Temperature
- Heat
- Light
- Moisture
- Temperature resistance
Q:11
What are the basic characteristics of packaging material?
- Protection against physical, chemical and biological hazards.
- Must be compatible with the product.
- Easy to store & transport.
- Regulatory compliance
- Tamper resistant
- Cost effective
Q:12
What is tamper-resistant?
Tamper means unauthorised access & in terms of packaging, specific features are applied to a package which give evidence that the pack is opened by someone.
Q:13
What is the most common primary packing for tablets?
- Alu/Alu Blisters
- Alu/PVC Blisters
Q:14
What Is PTP?
A blister pack is also known as PTP, which stands for push-through pack. We remove the tablet or capsule by pushing the forming foil, and the product comes out through the upper printed or lidding foil. Due to this property, blister packaging is also known as PTP.
Q:15
Which machine is used for the blistering of tablets?
Blister machines are used.
Q:16
What is a blister machine?
A machine used to pack the product, i.e tablets or capsules, into pockets formed by forming foils and sealed by a lidding foil is known as a blister machine.
Read details
Q:17
Types Of Blister Machines?
These are classified based on cavity-forming material,
- Thermo formable
- Cold Formable
- Both (dual functioning)
Q:18
Components of blister machines?
- Un-winding Rod
- Heating Station
- Forming Station
- Feeding Station
- Guiding Cam
- Inspection Camera
- Sealing Station
- Cooling Station
- Embossing Station
- Cutting Station
- Web Winding Rod
Q:19
Working principle of the blistering machine?
Blister machines work on the basic principle of pocket formation, either by heat or pressure and sealing the tablets/capsules by lidding foil.
Q:20
Which material is used for blister packaging?
- Cold Formable Foils
- Thermo Formable Foils
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Q:21
Examples of thermoformable foils?
The following materials are used for making cavities from thermoforming foil,
- PVC
- PVDC
- PTCE
- COC
Q:22
What Is PVC?
PVC stands for polyvinyl pyrrolidine.
Q:23
Disadvantages of PVC foil?
PVC has a poor moisture barrier.
Q:24
What Is PVDC?
PVDC stands for polyvinyl dien chloride
Q:25
What is PCTF?
PCTF stands for polychlorotrifluoroethylene.
Q:26
How are cavities formed during blistering?
Cavities in blister machines are formed with heat and air pressure in case of thermoformable machines, and in cold Formable foils, cavities or pockets are formed by application of pressure by Teflon punches.
Q:27
Role of chilled water in blister packaging?
Chilled water circulation is used at all the points where heating is applied to immediately cool down the pockets or sealed blisters to prevent deshaping of foils.
Q:28
Challenge tests for blister machines?
These are as,
- Empty pocket challenge test
- Empty blister challenge test
- Broken tablet challenge test
- Foreign particles challenge test
- Pinhole detector challenge test
Q:29
Frequency of challenge test?
- Before the batch starts
- After a major breakdown
- At the start of the shift
Q:30
What are the types of blister machine feeders?
- Vibratory feeder
- Brush box feeder
- Rolling drum feeder
- Chute Feeder
- SimTap feeder
Q:31
What are in-process checks during blister packaging?
The following are in-process checks
- Leakage test
- Batch Number Checking
- Expiry Date Embossing Checking
- Blister Sealing Temperature Checking
- Physical Appearance
Q:32
Critical process parameters of blister machines?
- Sealing temperature
- Sealing pressure
- Sealing time
Q:33
What is a leakage test for blisters?
A leak test is an in-process test performed for blisters to check that the foils are tightly sealed and there is no chance of air or moisture penetration inside pockets.
Q:34
How many blisters are used for the leakage test?
The number of blisters may vary depending on the make and model of the blister machine. The good practice is to check all blisters of one stroke.
Q:35
Which ink is used for leakage testers?
Methylene blue is used for leakage testing apparatus.
Q:36
What percentage of methylene blue is used?
A 2% vol/vol solution of methylene blue is used.
Q:37
What is the frequency of the leak test?
Perform leak testing in the following conditions,
- Before the batch starts
- After a change of forming foil
- After a change of lidding foil
- After a major breakdown
- After a power failure
- After the machine stops during breaks
- At the start of the shift
Q:38
What is knurling?
Knurling is the impressions, dots used on forming plates of blister machines to enhance the grip and to form a strong seal.
Knurling helps to prevent blister leakages.
Q:39
Types of Knurling?
The following are types of Knurling
- Dotted type
- Diamond type
- Cross net
Q:40
What Is GSM?
GSM stands for grams per square metre. The coating over PVC is expressed by GSM. Higher GSM ensures higher moisture protection.
Q:41
Formula to calculate GSM?
GSM is calculated by the following formula
Weight of sample ×1000
Area of sample
Q:42
What is cold forming foil?
Aluminium foil is a cold forming foil as no heat is required to form pockets; rather, the pressure is used.
Q:43
What is thermoforming foil?
PVC or PVDC foils are known as thermoforming foils, as pockets are formed by pre-heating the rigid PVC or PVDC.
Q:44
What is lidding foil?
The thin printed aluminium foil is a lidding foil in blister packaging.
Q:45
What is WVTR?
WVTR stands for water vapour transmission rate
Q:46
What is OTR?
OTR is the Oxygen transmission rate.
Q:47
Name of some blister machine sensors?
Different types of sensors are installed on blister machines & some are given as,
- Lidding foil sensor
- Forming foil sensor
- Product-level sensor
- Chilled water sensor
- Sealing plate sensor
- Door sensor
Q:48
How to perform auto packaging?
Cartoning machines or auto-cartoners are used in pharma for auto packaging.
Q:49
Name the sensors of cartoner machines?
Following main sensors are installed
- Product magazine sensor
- Product count sensor
- Low carton sensor
- Door sensor
- Hand wheel sensor
Q:50
How many servo motors are in a blister machine?
Following servo motors are installed
- Main cam
- Embossing cam
- Feeding station
- Puller system
Q:51
How is PVDC tested?
It is tested with Morpholine testing. Pour a single drop of morpholine on PVDC & observe the colour, the test is passed if it changes to a yellowish colour.
Q:52
What is a Pinhole detector?
A pinhole detector is installed on blister machines to find any holes in the foil.
Q:53
Blister packaging defects?
- Cuts on pockets
- Empty pockets
- Knurling issue
- Poor sealing
- Leak test failure
- Wrinkles on blisters
- Sticking
- Poor embossing
- I mark defects
- Printing defects
- Pinhole defects
- Foil thickness defects
Q:54
Common primary packing for syrups?
- Glass bottles
- Plastic Bottle
- PET bottles
Q:55
In-process test for liquid filling & packaging?
- Volume checking
- Optical checking
- Cap sealing inspection
- Leakage testing
- Labelling inspection
- Printed data checking
Q:56
Cap sealing defects?
- Improper sealing
- Cuts on caps
- Too hard sealing
Q:57
Labelling defects of glass bottles.
- Poor adhesion
- Folded corners
- Label peeling
Q:58
Primary packing for sterile products?
- Ampules
- Vials
- Infusion
Q:59
Area classification of blistering?
The blister packaging area falls under ISO class 8 at rest.
Q:60
Ink used for printed foils?
Heat-resistant, non-fading, food grade ink is used.
Q:61
Packaging area classification?
The packaging area must be in CNC condition, meaning cleaned but not classified.
Q:62
Temperature and humidity of packaging areas?
The general requirements for temperature and humidity in the packaging area are as follows
- Temperature 25°C
- Humidity 60 %
Q:63
Primary packing materials for semisolid?
- Collapsible tubes
- Jars
- Screwed bottles
Q:64
Defects of tube packaging?
- Sealing issue
- Tube deformation
- Filling Weight variation
- Embossing issue
Q:65
Name the top blister machine manufacturers?
- Uhlmann – Germany
- Romaco – Germany
- Intimac – Italy
- iPharmachine – China
- RIDAT – UK
- Hoonga A – Korea
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