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Pharmaceutical Packaging
What Pharma Is about?
13-02-2023
Pharma
API Formulation Nutraceuticals Biopharmaceuticals
Diagnostic
/Medical Device
What is Primary Pharma Packaging ?
Any material, including printed material, employed in
the packaging of a pharmaceutical product, excluding
any outer packaging used for transportation or shipment.
Primary packaging materials are those that are in direct
contact with the product.
4
Major Problems During Packaging
Protection
Moisture
Oxygen
Mechanical damage
Light
5
Regulatory & Filing terms
 USFDA – USA marketing
 EU – European Countries –standards
 21 CFR – Code of Federal Regulations
Filing Terms
ANDA - Abbreviated New Drug Application
NDA - New Drug Application
Pillow paks
Desiccants like Silica gel, Molecular Sieves, Carbon, etc or a mixture
of such packed in DuPont Tyvek.
7
DESICCARE -Pillow paks
Continuous strip - Roll Form – I mark
& Whole Punch
Tyvek Properties
 It has outstanding porous microbial barrier & is non leaching and
odorless.
 Best Strength, Non Tearable Material.
 Best Moisture Permeation.
 Inertness to most chemicals.
 Air permeability
 Clean peeling seals
 Low fiber tear.
8
Available Desiccants
 Silica gel
 Molecular Sieves
 Activated Carbon
 Montmorillonite Clay
 Silica gel + Carbon
 Silica gel + molecular Sieves
9
Application and Sizes
 Meets USFDA and EU standards
 Packaging of variety of products like pharmaceuticals, vitamins, Biological,
Medical Devices, Food, Optical, Clothing, Electronics and other Consumer
Products
 Available Sizes- 0.25 Gm, 0.5 Gm, 0.75 Gm, 1 Gm, 1.5 Gm, 2 Gm, 3 Gm,
5 Gm, 10 Gm, 12 Gm and 14 GM
 Also available in continuous roll form upto 5 gm.
10
Adsorption Rates at Low Humidity Levels
T = 25°C, 10% r.h., static conditions
0
5
10
15
20
0 50 100 150 200 250
time [h]
sorption
[%]
Tri-Sorb®
Desi Pak®
Sorb-It®
11
MS
Clay
SG
• At low relative
humidity,Clay
adsorbs more
moisture than SG as
time goes on.
• MS adsorbs the
most at a quickest
rate.
Adsoprtion Rates at High Humidity
Levels
12
T =30 °C, 60%r.h., static conditions
0
5
10
15
20
25
30
0 5 10 15 20
time [h]
sorption
[%]
Desi Pak®
Sorb-It®
Tri-Sorb®
SG
MS
Clay
•At high relative humidity,
SG adsorbs more moisture
than Clay as time goes on.
• MS adsorbs a lot of
moisture quickly at first and
then reaches capacity.
Montmorillonite Clay
 Montmorillonite clay is a naturally occurring adsorbent created by the controlled
drying of magnesium aluminum silicate of the sub-bentonite type.
 However, this property causes clay to give up moisture readily back into the
container as temperatures rise.
 Clay is a good basic desiccant that works satisfactorily below 120°F
(approximately 50°C). Above 120° F, there is a possibility that the clay will give
up moisture rather than pulling it in, so anticipated storage and transportation
conditions should be considered.
 Clay is highly effective within normal temperature and relative humidity ranges.
Its appearance is that of small gray pellets.
UNIT PAKS
 Unit Paks are, we can say pillow paks but in larger sizes are
manufactured using DuPont Tyvek® and several custom
substrates
 1 unit = 28gms(silica gel, molecular sieve, etc.) according to
MIL-D-3464 specifications.
 For E.g : Gabapentin Capsules
Canister Desiccants
 It offers DMF grade desiccants in Canisters.
 Canisters (HDPE- High Density Polyethylene )
are small, rigid, cylindrical containers filled with
desiccants.
15
Available Desiccants in Canisters
 Silica gel
 Molecular Sieves
 Activated Carbon (Odor Control) –Tyroxine
 Silica gel + Carbon
 Silica gel + molecular Sieves
16
Application and Sizes
 Meets USFDA and EU standards
 Used along with moisture sensitive tablets ,
capsules which are packed in bottles.
 Mainly in Pharmaceuticals and Nutraceuticals.
 For Eg :Donepezil Tablets, Chlorpromazine HCL
Tablet 10 , 25, 50, 100 & 200 Mg
 Available Sizes- 1 gm, 2 gm, 3 gm.
17
Parameters Pillow Packs Canister
Construction Tyvek Paper HDPE
Exposure for moisture
pick up Fast Medium
Ink Marks on
Tablets/Caps No Yes
USFDA Compliance Yes Yes
EU Compliance Yes Yes
Available Grams 0.25 – 14gms 1 -3 gms
Shelf Life & storage life 2 years 2 years
18
 “O-Sorb” is designed to remove the Oxygen content inside
any packaged environment.
O-Sorb’s Unique blend of absorbents will pick up
approximately three times its weight of oxygen preventing
the harmful effects of Oxygen.
Products Comply to: USFDA, EU , 21
CFR.
O-Sorb
Contents
IRON POWDER
& Silicon
Dioxide
Sodium
Chloride
Activated Carbon
WATER
20
Application and Sizes
 Protection of API/formulation (Tablets and
Capsules, Dry powder) in bottle packing against
oxygen for oxygen sensitive molecules
 Available Sizes-
10 CC ,20 CC ,30 CC, 50 CC, 100 CC, 200 CC,
500 CC, 1000 CC, 2000 CC, 3000 CC -O-Sorb .
21
PHARMACEUTICAL COILS
 Pharma Desiccants is the brand for pharmaceutical coils.
 DMF grade type-III material
 Coils are available in 3 types:
Cotton
Polyester
Rayon
22
COTTON COIL
Composed of 100% bleached, absorbent cotton
• Natural fiber
• Cuts easily
• Moisture content : NMT 8.0%
• Creates dry environment inside the bottle
• Most commonly used in bottling of tablets
and capsules
• Biodegradable
• For E.g Azithromycin tablets
Characteristics:
23
RAYON COIL
Formulated of 100% absorbent rayon fibers
• Man-made fiber
• Uniform fiber length
• Cuts or tears easily
• Moisture content : NMT 11.0%
• Creates dry environment inside the bottle
• Most commonly used in bottling of tablets.
• Biodegradable.
Characteristics:
24
POLYESTER COIL
Formulated of 100% polyester fibers
• Man-made fiber (petroleum derived)
• Uniform fiber length
• Non-fluorescent
• Non-absorbent- will not introduce moisture or extract
moisture from the bottle
• Moisture content : NMT 1.0%
• Most commonly used in bottling of soft-gel capsules.
• For e.g : Multivitamin soft gel capsules, Lenalidomide
Capsules
Characteristics:
25
Uses & Applications
To provide:
Safe Non-toxic
Easy to use
Traditional Filler.
To ensure its mechanical integrity in shipping and storing of
ethical & generic pharmaceuticals, vitamins and food
supplements.
Tablet /Capsules (Hard/Soft) packaging (Filler)
26
FOAM PLUGS
 Foam plugs are white , cylindrical, made of poly-urethane.
 Widely used as a filler with tablets, capsules when bottled.
 Foam Plugs are tested for their performance with respect to
health standards as per ACUTE SYSTEMIC TOXICITY
TEST.
27
Features
Non-Reactive
Produce in Blocks
Non-Absorbent
Non-Toxic
Auto-clavable
28
Applications & Size Available
 Void space filler
 Protection for tablets from chipping due to rattling.
 Available in cylindrical shapes
Desiccant Tablets
 MOC:
 Molecular sieve powder,4A
 Silica Gel Powder
Both used for MVTR testing – Blister,Alu-Alu packing.
 MOC:
 Calcium Chloride
For HDPE bottles testing -MVTR
Thank You

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High-Quality pharmaceutical Desiccant Packaging Solutions For Healthcare Product Packaging.

  • 2. What Pharma Is about? 13-02-2023
  • 3. Pharma API Formulation Nutraceuticals Biopharmaceuticals Diagnostic /Medical Device
  • 4. What is Primary Pharma Packaging ? Any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment. Primary packaging materials are those that are in direct contact with the product. 4
  • 5. Major Problems During Packaging Protection Moisture Oxygen Mechanical damage Light 5
  • 6. Regulatory & Filing terms  USFDA – USA marketing  EU – European Countries –standards  21 CFR – Code of Federal Regulations Filing Terms ANDA - Abbreviated New Drug Application NDA - New Drug Application
  • 7. Pillow paks Desiccants like Silica gel, Molecular Sieves, Carbon, etc or a mixture of such packed in DuPont Tyvek. 7 DESICCARE -Pillow paks Continuous strip - Roll Form – I mark & Whole Punch
  • 8. Tyvek Properties  It has outstanding porous microbial barrier & is non leaching and odorless.  Best Strength, Non Tearable Material.  Best Moisture Permeation.  Inertness to most chemicals.  Air permeability  Clean peeling seals  Low fiber tear. 8
  • 9. Available Desiccants  Silica gel  Molecular Sieves  Activated Carbon  Montmorillonite Clay  Silica gel + Carbon  Silica gel + molecular Sieves 9
  • 10. Application and Sizes  Meets USFDA and EU standards  Packaging of variety of products like pharmaceuticals, vitamins, Biological, Medical Devices, Food, Optical, Clothing, Electronics and other Consumer Products  Available Sizes- 0.25 Gm, 0.5 Gm, 0.75 Gm, 1 Gm, 1.5 Gm, 2 Gm, 3 Gm, 5 Gm, 10 Gm, 12 Gm and 14 GM  Also available in continuous roll form upto 5 gm. 10
  • 11. Adsorption Rates at Low Humidity Levels T = 25°C, 10% r.h., static conditions 0 5 10 15 20 0 50 100 150 200 250 time [h] sorption [%] Tri-Sorb® Desi Pak® Sorb-It® 11 MS Clay SG • At low relative humidity,Clay adsorbs more moisture than SG as time goes on. • MS adsorbs the most at a quickest rate.
  • 12. Adsoprtion Rates at High Humidity Levels 12 T =30 °C, 60%r.h., static conditions 0 5 10 15 20 25 30 0 5 10 15 20 time [h] sorption [%] Desi Pak® Sorb-It® Tri-Sorb® SG MS Clay •At high relative humidity, SG adsorbs more moisture than Clay as time goes on. • MS adsorbs a lot of moisture quickly at first and then reaches capacity.
  • 13. Montmorillonite Clay  Montmorillonite clay is a naturally occurring adsorbent created by the controlled drying of magnesium aluminum silicate of the sub-bentonite type.  However, this property causes clay to give up moisture readily back into the container as temperatures rise.  Clay is a good basic desiccant that works satisfactorily below 120°F (approximately 50°C). Above 120° F, there is a possibility that the clay will give up moisture rather than pulling it in, so anticipated storage and transportation conditions should be considered.  Clay is highly effective within normal temperature and relative humidity ranges. Its appearance is that of small gray pellets.
  • 14. UNIT PAKS  Unit Paks are, we can say pillow paks but in larger sizes are manufactured using DuPont Tyvek® and several custom substrates  1 unit = 28gms(silica gel, molecular sieve, etc.) according to MIL-D-3464 specifications.  For E.g : Gabapentin Capsules
  • 15. Canister Desiccants  It offers DMF grade desiccants in Canisters.  Canisters (HDPE- High Density Polyethylene ) are small, rigid, cylindrical containers filled with desiccants. 15
  • 16. Available Desiccants in Canisters  Silica gel  Molecular Sieves  Activated Carbon (Odor Control) –Tyroxine  Silica gel + Carbon  Silica gel + molecular Sieves 16
  • 17. Application and Sizes  Meets USFDA and EU standards  Used along with moisture sensitive tablets , capsules which are packed in bottles.  Mainly in Pharmaceuticals and Nutraceuticals.  For Eg :Donepezil Tablets, Chlorpromazine HCL Tablet 10 , 25, 50, 100 & 200 Mg  Available Sizes- 1 gm, 2 gm, 3 gm. 17
  • 18. Parameters Pillow Packs Canister Construction Tyvek Paper HDPE Exposure for moisture pick up Fast Medium Ink Marks on Tablets/Caps No Yes USFDA Compliance Yes Yes EU Compliance Yes Yes Available Grams 0.25 – 14gms 1 -3 gms Shelf Life & storage life 2 years 2 years 18
  • 19.  “O-Sorb” is designed to remove the Oxygen content inside any packaged environment. O-Sorb’s Unique blend of absorbents will pick up approximately three times its weight of oxygen preventing the harmful effects of Oxygen. Products Comply to: USFDA, EU , 21 CFR. O-Sorb
  • 21. Application and Sizes  Protection of API/formulation (Tablets and Capsules, Dry powder) in bottle packing against oxygen for oxygen sensitive molecules  Available Sizes- 10 CC ,20 CC ,30 CC, 50 CC, 100 CC, 200 CC, 500 CC, 1000 CC, 2000 CC, 3000 CC -O-Sorb . 21
  • 22. PHARMACEUTICAL COILS  Pharma Desiccants is the brand for pharmaceutical coils.  DMF grade type-III material  Coils are available in 3 types: Cotton Polyester Rayon 22
  • 23. COTTON COIL Composed of 100% bleached, absorbent cotton • Natural fiber • Cuts easily • Moisture content : NMT 8.0% • Creates dry environment inside the bottle • Most commonly used in bottling of tablets and capsules • Biodegradable • For E.g Azithromycin tablets Characteristics: 23
  • 24. RAYON COIL Formulated of 100% absorbent rayon fibers • Man-made fiber • Uniform fiber length • Cuts or tears easily • Moisture content : NMT 11.0% • Creates dry environment inside the bottle • Most commonly used in bottling of tablets. • Biodegradable. Characteristics: 24
  • 25. POLYESTER COIL Formulated of 100% polyester fibers • Man-made fiber (petroleum derived) • Uniform fiber length • Non-fluorescent • Non-absorbent- will not introduce moisture or extract moisture from the bottle • Moisture content : NMT 1.0% • Most commonly used in bottling of soft-gel capsules. • For e.g : Multivitamin soft gel capsules, Lenalidomide Capsules Characteristics: 25
  • 26. Uses & Applications To provide: Safe Non-toxic Easy to use Traditional Filler. To ensure its mechanical integrity in shipping and storing of ethical & generic pharmaceuticals, vitamins and food supplements. Tablet /Capsules (Hard/Soft) packaging (Filler) 26
  • 27. FOAM PLUGS  Foam plugs are white , cylindrical, made of poly-urethane.  Widely used as a filler with tablets, capsules when bottled.  Foam Plugs are tested for their performance with respect to health standards as per ACUTE SYSTEMIC TOXICITY TEST. 27
  • 29. Applications & Size Available  Void space filler  Protection for tablets from chipping due to rattling.  Available in cylindrical shapes
  • 30. Desiccant Tablets  MOC:  Molecular sieve powder,4A  Silica Gel Powder Both used for MVTR testing – Blister,Alu-Alu packing.  MOC:  Calcium Chloride For HDPE bottles testing -MVTR