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Pillow packs and unit paks
1.
2. • What is packaging ?
Packaging is defined as the collection of different
component which surround the pharmaceutical product
from the time of production until its use.
• Importance of packaging ?
•
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.
3. Containment
Not to leak, nor allow diffusion and permeation.
Strong enough to hold the contents during handling.
Protection from:
Light
Moisture
Oxygen
Biological contamination
Mechanical damage
Counterfeiting
4. A desiccant is a Hygroscopic substance that induces or
sustains a state of dryness (desiccation) in a moderately
well-sealed container.
Commonly encountered pre-packaged desiccants are
solids,
and
work
through absorption or adsorption of water, or a
combination of the two.
Pre-packaged desiccant is most commonly used to
remove excessive humidity that would normally degrade
or even destroy products sensitive to moisture.
Some commonly used desiccants are: silica
gel, activated charcoal, calcium chloride, montmorillonite
clay, and molecular sieves.
5. • One measure of desiccant efficiency is the ratio
(or percentage) of water storable in the desiccant,
relative to the mass of desiccant.
• Another measure is the residual relative humidity of the
air or other fluid being dried.
• The
performance
of
any
desiccant
varies
with temperature and both relative humidity and absolute
humidity.
• To some extent, desiccant performance can be precisely
described, but most commonly, the final choice of which
desiccant best suits a given situation, how much of it to
use, and in what form, is made based on testing and
practical experiment.
6. • Pillow paks can be used to absorb moisture, vapor, gas
or odor.
• They are made of non-woven Tyvek material that is
manufactured by Dupont.
• Many great products resulted from accidental laboratory
discoveries, such as X-rays, Penicillin, and Post-It
Notes. Likewise, Tyvek was discovered in 1955 in an
experimental lab when DuPont researcher Jim White
noticed white polyethylene fluff coming out of a
pipe. This new material went into development and a
patent proposal was submitted the following year. In
1965 DuPont trademarked the Tyvek name and
commercial production finally began two years later.
7. • DuPont™ Tyvek® offers the best characteristics of
paper, film, and fabric in one material.
• Amazingly Light
• Incredibly Water and Moisture Resistant
• Tough
• 100% Recyclable
• Distinctive
Bright white and silky smooth, Tyvek® has a
distinctive look and feel that enhances graphic
images and instantly sets it apart from all other
materials.
8. Silica gel is a granular, vitreous, porous form
of silicon dioxide made synthetically
from sodium silicate.
In many items, moisture encourages the
growth of mold and spoilage. Through the
inclusion of silica gel packets these items
can be preserved longer.
A molecular sieve is a material containing
tiny pores of a precise and uniform size
that is used as
an adsorbent for gases and liquids.
Molecules small enough to pass through
are adsorbed while larger molecules are
not.
A molecular sieve can adsorb water up to
22% of its own weight.
9. Pillow
packs
range in
sizes from
0.25grms
to 14grms.
Activated carbon, also
called activated
charcoal, activated
coal or carbo activatus, is a
form of carbon that has been
processed to make it
extremely porous and thus
to have a very large surface
area available for adsorption.
10. Product
Compliance
PILLOW PAK®
(Mfg. )
21CFR, EC/EU
compliant
LOCAL POUCH
Nil
DMF No.
11871 Type-III
Nil
Desiccant Type
Silica Gel
Remarks
Pillow Pak is Safe to use
for Food/Pharma Grade
USFDA Drug Mater File
No. (can use with direct
contact of food grade
product)
Silica Gel
Desiccant Form
Beads
Beads/Granular
Adsorption
Capacity
@40%Rh,25ºC
@80%Rh,25ºC,
Min. 22 %
Min. 33%
≥ 19%
≥ 29 %
Granular break easily,
Powdered Silica produces
more fine dust on moisture
contact
High adsorption capacity
for longer protection
11. Substrate
(Packet Material)
Tyvek Microporous, Spunbonded olefin
Linting /Fibers
Tearing Strength
Of Packet
No
Very High Tear
strength
Dusting Properties
Non-dusting
Regeneration
Yes
Printing
Packet
Dimensions
COA
Food Grade Ink
Standard
MSDS
Cost
Supplied with each
lot
Available
High
Spun bonded Olefin is
Composite Paper better for strength &
permeability of moisture
Chances are there Fibers may stick to
product in which it is used.
Packet Integrity
Medium strength important to avoid mixups
May Create
Dust may get mixed with
Problem of Dusting product.
No
Composite Paper will
burn at high temperature.
Non-Food Grade Safety?
Standard
On request only
Yes
Medium
Price or
performance?????
12. Parameters
Construction
Exposure for moisture
pick up
Ink Marks on
Tablets/Caps
Pillow Packs
Tyvek Paper
Fast
No
Rate of adsorption at
90% RH
38.5%
Regeneration Process
Yes
Canister
HDPE
Medium
Yes
32%
No
FDA Compliance
Yes
0.25 gm – 14gm
1,2,3 gm only
Tyvek also gives higher strength
Pillow pack hold advantages
Canister - Ink may leave the
mark/Color on Tablets/ Capsules
More Adsorption power for Pillow
Pack
100% Chances to reuse in case of
doubt, Being HDPE construction not
possible
Yes
Available Grams
Remarks
Shelf Life & storage life
Min 3 years
More range available in Pillow Paks
Min 1 year
Advantage with Pillow pack
Confusions with
Tablets
NIL
Medium
End user may get confused with shape
& size of canister with compared to
tablet size.
Cost
Low
Very High
Cost & better economics with pillow
pack
13. • Unit Paks are, we can say pillow paks but in larger sizes.
• 1 unit= 28gms(silica gel, molecular sieve etc) according
to MIL-D-3464 specifications.
• Upon it’s wartime experience in the development of food
and drug drying agents, The U.S. Department of
Defense (DOD) developed specifications, addressing the
elimination of corrosion and mildew by adsorbing the
moisture from the air of an enclosed space. The DOD
released MIL-D-3464 covering the use of bagged
desiccants for packaging and static dehumidification.
• MIL-D-3464 specification has become the only objective
source for packaging engineers.
• Sizes: Available in 1/6, 1/3, 1/2, 1, 2, 4, 6, 8, 16 or 80
"unit"