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Polymers
•Polymers are long chain giant organic molecules are assembled from many 
smaller molecules called monomers. 
•Polymers consist of many repeating monomer units in long chains. 
•A polymer is analogous to a necklace made from many small beads 
(monomers).  
•Another common name for many synthetic polymers is plastic which comes 
from the Greek word "plastikos", suitable for molding or shaping. 
•Many objects in daily use from packing, wrapping, and building materials 
include half of all polymers synthesized.
•Other uses include textiles, TV's, CD's, automobiles, and many other all are 
made from polymers.
•A quarter of the solid waste from homes is plastic materials - some of which 
may be recycled as shown in the table on the left.
Natural Gas Liquids (Ethane, Propane)
or Naphtha (from Crude Oil)

Steam Cracking
Ethylene, Propylene
Other Polymers

Chemicals

POLYETHYLENE



polyethylene is created through the polymerization of ethylene (i.e., 
ethene).
Polyethene, Polythene, PE, LDPE, HDPE, MDPE, LLDPE
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)
    Low-density polyethylene (LDPE) is 
a thermoplastic made from the monomer
ethylene
     Imperial Chemical Industries first discovered 
low-density polyethylene in 1933. Its first 
commercial use came during World War II, when 
it was used as insulation on radar cables.
•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.





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.
Recycling
number

Image

Abbreviation

1

PETE or PET

2

HDPE

3

PVC or V

4

LDPE

5

PP

6

PS

7

OTHER or O
Injection
The injection blow moulding machine is based on an extruder barrel and screw assembly which melts 
the polymer. The molten polymer is fed into a manifold where it is injected through nozzles into a 
hollow, heated preform mould. The preform mould forms the external shape and is clamped around a 
mandrel (the core rod) which forms the internal shape of the preform. The preform consists of a fully 
formed bottle/jar neck with a thick tube of polymer attached, which will form the body.

Blowing
The preform mould opens and the core rod is rotated and clamped into the hollow, chilled blow mould. 
The core rod opens and allows compressed air into the preform, which inflates it to the finished article 
shape.  

Ejection
After a cooling period the blow mould opens and the core rod is rotated to the ejection position. The 
finished article is stripped off the core rod and leak-tested prior to packing. The preform and blow mould 
can have many cavities, typically three to sixteen depending on the article size and the required output. 
There are three sets of core rods, which allow concurrent preform injection, blow moulding and ejection.
Process steps of 
Injection Blow 
Moulding
The blow moulding machine is based on a standard extruder barrel and screw 
assembly to plasticise the polymer. The molten polymer is led through a right angle 
and through a die to emerge as a hollow (usually circular) pipe section called a 
parison.
When the parison has reached a sufficient length a hollow mould is closed around 
it. The mould mates closely at its bottom edge thus forming a seal. The parison is 
cut at the top by a knife prior to the mould being moved sideways to a second 
position where air is blown into the parison to inflate it to the shape of the mould.
After a cooling period the mould is opened and the final article is ejected.
To speed production several identical moulds may be fed in cycle by the same 
extruder unit. The process is not unlike that used for producing glass bottles, in 
that the molten material is forced into a mould under air pressure.









One of the most common methods of film manufacture 
is Blown Film (also referred to as the Tubular Film) 
Extrusion. The process involves extrusion of a plastic 
through a circular die, followed by "bubble-like" 
expansion. The principal advantages of manufacturing 
film by this process include the ability to: 
Produce tubing (both flat and gussetted) in a single 
operation
Regulation of film width and thichness by control of the 
volume of air in the bubble, the output of the extruder 
and the speed of the haul-off
Eliminate end effects such as edge bead trim and non 
uniform temperature that can result from flat die film 
extrusion
Capability of biaxial orientation (allowing uniformity of 
mechanical properties)
Blown Film Extrusion can be used for the manufacture of 
co-extruded, multi-layer films for high barrier 
applications such as food packaging.
3 layer die head with air ring 
and internal bubble cooling

Film bubble going into a 
collapsing frame

Taking an edge trim 
from film web

The lay flat tube is separated 
into 2 single sheets 

Control panel graphic from an 
automated blown film line

Blow Film Line In Action
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). 
PE Demand by Conversion Process

• Food Packaging
• Hygiene & Medical
• Consumer & Ind. Liners
• Stretch Films
• Agricultural Films
• HDSS


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
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.
Container/
Film
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









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
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







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.



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.
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.
LDPE Bags
LDPE Bags
LDPE Bags

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