Sorbead India is one of best supplier of LDPE bags which are USFDA approved and anti static, use to pack pharmaceutical tablets and capsules this plastic low density polyethylene bags.
8. Types of Polyethylene
HDPE (0.940-0.965)
“High Density”
LLDPE (0.860-0.926)
“Linear Low Density”
O
C-OH
O
O
O
O
O
LDPE (0.915-0.930)
“Low Density”
O
O
O
O
O
High Pressure Copolymers
(AA, VA, MA, EA)
10. •LDPE (Low Density Polyethylene) is defined by a density range of 0.910 - 0.940 g/cm3.
•It has a high degree of short and long chain branching, which means that the chains do not
pack into the crystal structure as well.
•It has therefore less strong intermolecular forces as the instantaneous-dipole induceddipole attraction is less.
•This results in a lower tensile strength and increased ductility.
•LDPE is created by free radical polymerization.
•The high degree of branches with long chains gives molten LDPE unique and desirable flow
properties.
11.
The SPI resin identification coding system is a set of symbols
placed on plastics to identify the polymer type.
It was developed by the Society of the Plastics Industry (SPI)
in 1988, and is used internationally.
The primary purpose of the codes is to allow efficient
separation of different polymer types for recycling.
Separation must be efficient because the plastics must be
recycled separately. Even one item of the wrong type of resin
can ruin a mix.
20. Applications
Blown film can be used either in tube form (e.g. for plastic bags and sacks) or the tube
can be slit to form a sheet.
- Industry packaging (e.g. shrink film, stretch film, bag film or container liners),
- Consumer packaging (e.g. packaging film for frozen products, shrink film for
transport packaging, food wrap film, packaging bags, or form, fill and seal packaging
film),
- Laminating film (e.g. laminating of aluminium or paper used for packaging for
example milk or coffee),
- Barrier film (e.g. film made of raw materials such as polyamides and EVOH acting
as an aroma or oxygen barrier used for packaging food, e. g. cold meats and cheese),
- films for the packaging of medical products, Agricultural film (e.g. greenhouse
film, crop forcing film, silage film, silage stretch film).
21. PE Demand by Conversion Process
• Food Packaging
• Hygiene & Medical
• Consumer & Ind. Liners
• Stretch Films
• Agricultural Films
• HDSS
22.
Plastics and rubbers are used in different packaging
materials and dosing devices
These materials are in direct contact with the
Pharmaceutical product
The final use of the product determines the risk of
possible interactions with the product
Extractables and leachables can be harmful and can
possibly alter the pharmaceutical product
23. Extractable :
Compounds that can be extracted from
packaging (i.e. elastomeric, plastic
components or coating of the container
and closure system) when in the presence
of selected solvent or process
Leachable :
Compounds that leach from packaging
as a result of direct contact with the
formulation of the drug product and thus
could potentially be dosed to a patient.
Can also get interaction with a product
component to produce an impurity that
requires stability monitoring.
27. Potential Sources of Extractables from elastomeric or plastic
components:
Additives and processing aids, e.g. antioxidants, stabilizers,
plasticizers, emulsifiers etc.
Trace level contaminants and reaction products contained in
additives
Monomers
Secondary reaction products from processing
Pigments
Contaminants and/ or reaction products from storage/shipping
=> Conduct risk assessment based on this information regarding the
identity and amounts of ingredients
28.
Based on Extractable study suitable test methods for
testing of potential leachables in drug product have to
be developed
Recovery of reference compounds could be optimized
by spiking into a drug product formulation matrix.
Based on Toxicological Expertise limits for potential
leachables have to be defined
Validate the analytical methods
Methods for leachables studies are specific to the
finished product
Determine shelf-life acceptance criteria for leachables
based on the toxicological risk assessment
29.
30.
31. Surface Properties
Lubricants – Prevent sticky to machine
Slip & Blocking Agent – Prevent film & sheet
sticky
Anti Static Agent – Prevent static charges on
surface
Coupling Agent – Improve bonding between
polymer & filler
Welty Agent – Stabilize dispersion of Fillers
Anti Fogging Agent – Disperse moisture
droplets on film
Mechanical Properties
Plasticizers – Flexibility
Impact Modifier – Improves impact
strength
Reinforcy fillers – Increase Strength
Nucleatic agent – Modify Crystalling
Morphology
32.
By virtue of their insulting nature, polymers of all types
allow static charge to build up on their surfaces, and
films have large surface area to volume ratio.
Such static charge build up leads to several undesirable
consequences in the final products.
Built up static charge can attract dust on to a food
package, which is undesirable aesthetically.
It cause several processing problems such as winding of
films, agglomeration of powders during transport,
adhesion of film during processing, etc..
It can be avoided by using masterbatches containing
anti-static agents which will used internally with
polymer.
33.
Internal antistats are
migratory in nature.
The strongly polar hydrophilic
end adsorbs water molecules
which eliminates static
charges by ionic conduction.
The long hydrocarbon chain
length constitutes the
hydrophobic group and
controls the rate of diffusion
of the antistat to the surface
of the polymer product.
34.
35. 1. If the other additives are also migratory, they compete
with the antistats for diffusion through the polymer
matrix & also compete with the antistats for surface
coverage.
Slips are a common example of this type of additive,
which may exert adverse influenced on anti-static
properties.
2. Amine & Amide type antistats are basic(Alkaline) in
nature, which may react with some acidic flame
retardants, which can result in reduction of anti-static
properties.