packing technology pharma sciences

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Syallabus: Introduction to packing technology and different types of packing materials used in pharma
industry, advantage of packing
To set out the important role of the pack and the need to consider the total packaging operation as part of any drug
discovery and development programme. Although demands on the type of pack (material, style, etc.) will vary
according to the characteristics of the product; how it is produced and distributed; where, how and to whom it is
sold; how it is used/administered; etc., certain factors are shared irrespective of the product classification (i.e.
ethical, over the counter (OTC), veterinary, etc.). Pharmaceutical products generally require a standard of
packaging which is superior to that of most other products in order to support and comply with their main
requirements, i.e. proven efficacy, safety, uniformity, reproducibility, integrity, purity with limited impurities,
minimum side-effects coupled to minimum product liability risks, and a good shelf-life stability profile. Since all
these terms tend to be well established, but not always fully understood, it may be useful to emphasise the
importance of each and its relevance to product pack development. The packing techno has the following
functions to do
Uniformity
Uniformity applies within and between batches and usually refers to the quantification of active ingredients, excipients and
impurities/degradation. The term applies to the minimum of variation between items, doses, etc., both as active constituents
and excipients and any factors which control dissolution, bioavailability, etc. It may be expressed as a percentage of the initial
target figure since in this way any relationship with storage time, temperature, etc. can be quantified. However, changes in
uniformity or variable uniformity after storage may relate to variations in the product, the pack or the environment.
Purity
Purity today embraces both the percentage of active ingredient and, when possible, the identity and level of impurities
present. If one looks back to pharmacopoeias of say 55 years ago it is quite remarkable that in accepting a purity of 99.0%, 98.
5%, 95.0%, etc., little attention was paid to the remaining percentage which could consist of impurities or degradation of
products related to the process of manufacture and the drug entity itself. Today greater emphasis is placed on the ‘other
constituents’as by-products of the manufacturing process and/or degradation of the drug or formulation. In the same way that
modern analytical methods have made the quantifications of impurities practical,modern chemicaltechniques have made it more
readily possible to separate major impurities. As a result, purer drug substances are being produced today. Impurity levels of
0.1% or more normally have to be identified and safety detail quantified.
Integrity
Integrity covers any assurance that the ingredients are correct in quality and quantity, the formulation is correctly compounded
and exhibits the required bioavailability profile, and the pack is to specification and correctly assembled with the quantity of
product and the product-pack correctly labelled and identified. Integrity, therefore, covers all aspects related to quality,
quantity and security and is thus a function of production and quality control/assurance. Security against counterfeiting has

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recently increased in importance.

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Minimum side-effects
It is perhaps not always recognised that most drugs have some side-effects. Provided these are minor the drug usually will be
accepted. This is generally known as a risk-benefit ratio, and therefore varies according to the severity of the disease. A
person using a life-extending drug usually accepts side-effects which would be unacceptable for a milder disease. These side-
effects may occur from the drug itself or other excipients in the formulation. In this context any move towards simpler
formulations, e.g. the removal of colourants, flavours, preservatives, etc., can reduce some of the risks associated with side-
effects. Since packaging, by interaction, extraction, or migration may change, add to or even subtract from the product, this
can contribute as a sideeffect factor.
Good stability with a clearly defined shelf-life profile
Occasionally drugs have a limited shelf life irrespective of the pack used, but at the other extreme, some drug formulations are
inherently stable and therefore a pack is needed only to prevent direct contamination, i.e. dirt, dust, bacteria, etc. from the
outside atmosphere, and for containment. However, few pharmaceutical products can exist without the supporting role of a
pack, as many of the above product factors are not only interdependent with the pack, but ultimately represent a compromise
between these and other conflicting needs. Traditionally pharmaceutical products have aimed for a 5 year shelf life where
practical, or at least 3 years. General stability is currently supported through the International Conference on Harmonisation
(ICH) guidelines.
Some factors that may influence the pharmaceutical pack Selection are
Pharmaceutical products and/or their packs can be classified under a number of categories, i.e.
• the type of dosage form
• the route or mode of administration or use
• the type of pack
• the mode of sale/marketing area
• the mode of dispensing via a combined device/pack
• administration by a device separate to the pack.
•
The prime function of the packing technology is to provide the good strength to the and mechanical protection to the
formulation against
S—shock Physical hazards associated with storage and carriage, i.e. during loading, unloading, movement,
handling, warehousing, etc.

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C—
compression
R—rattle
(vibration)
A—abrasion
P—puncture
C—contamination/compatibility between pack
and product
A—ageing (certain combinations involving
several sources)
R—rodents or similar animal sources of
contamination T—theft
M—moisture (relative humidity (RH), rain, sea
water) I—insects
S—sunlight or any light sources
T—temperature (extremes) M—
microbiological
A—atmospheric—gases, pressure differentials, dirt, dust, oxygen, carbon dioxide, etc.
R—reuse/recycling/recovery/reduce, i.e. ‘the four Rs’
D—disposal
Classification of the packing Material
Primary packing Material - The material that is in the direct contact with the formulation. E.g Foils
This is the first packaging envelope which is in touch with the dosage formor equipment. The packaging needs
to be such that there is no interaction with the drug and will provide proper containment of pharmaceuticals.
E.g. Blister packages, Strip packages, etc.
2. Secondary Packaging: This is consecutive covering or package which stores pharmaceuticals packages it for
their grouping. E.g. Cartons, boxes.
3. Tertiary packaging: This is to provide bulk handling and shipping of pharmaceuticals from one place to
another. E.g. Containers, barrels, etc.
Primarily two types of containers are used for packaging: 1. Glass Containers 2. Plastic Containers Glass
Containers.
These need to be chemically inert, impermeable, strong and rigid proving FDA clearance.

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Types of Primary Material Used
1. Glass 2. Plastics
. Four types of Glass is being used in pharmaceutical industry,
1. Type I-Borosilicate glass: Highly resistant and chemically inert glass. Alkali’s and earth cations of glass
are replaced by boron and/or aluminum and zinc. These are used to contain strong acids and alkalis.
2. Type 2-Treated soda-lime glass: These are more chemically inert than Type I glass. The glass surface is
de-alkalized by “Sulfur treatment” which prevents blooming/weathering from bottles.
3. Type III- Regular soda lime glass: Untreated soda lime glass with average chemical resistance.
4. Type IV- General Purpose soda lime glass/ General purpose : Glass is not used for parenterals, used
only for products intended to be used orally or topically. Colored glass is used to screen out Ultraviolet rays
and is thus effective for protecting contents from light. Amber glass and red colored glass is used for this
purpose. Major disadvantage of glass as a packaging material is its fragility and weight. Plastic Containers:
Plastic containers of high quality can be easily formed with different designs. These packages are
extremely resistant to breakage and leakage. Primarily plastic containers are made from the following
polymers:
1. Polyethylene (PE): Provides good barrier against moisture, relatively poor one against oxygen and other
gases. High density polyethylene is used with density ranging from 0.91-0.96 leading to four basic
characteristics of container, (1) Stiffness, (2) Moisturevapor transmission, (3)stress cracking and(4)clarity
or translucency based on polymer density used.
2. Polypropylene (PP): Polypropylene has features of polyethylene in addition it does not stress -crack in
any condition. Hot aromatic or halogenated solvents soften the package. It has high melting point making it
suitable for boilable packages and products needed to be sterilized. Brittleness at low temperature is its
major disadvantages.
3. Polyvinyl Chloride (PVC): Can be produced with crystal clear clarity, will provide good gaseous
barrier and stiffness. Reduction in residual vinyl chloride monomers had further enhanced PVC quality.
products.
4.Polystyrene has high water and gaseous permeability also these are easily stretchable and breakable. To
increase their strength and quality for permeability polystyrene is combined with rubber and acrylic
compounds. Base on the composition these are classified as intermediate impact, high impact and super
impact packages.
5. Nylon (polyamide): Many dibasic acids and amines combine to provide numerous varieties of nylon.
Nylon is extremely strong and is quite difficult to be destroyed by mechanical means. Nylon provides

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resistance to wide range of acids and alkali only disadvantage of it is being permeable to water vapor for
some amount this can also be dealt with coating of PE over the container. Not used for long termstorage of
products.
6. Polycarbonate: Has an ability to be sterilized repeatedly. It has immense rigidity and is a possible
replacement for glass, vials and syringes. It has qualities like high dimensional stability, high impact
strength, resistance to strain, low water absorption, transparency, and resistance to heat and flame.
Polycarbonates have impact strength five times greater than any other common packaging plastics.
7. Acrylic multipolymers (Nitrile Polymers): These are polymers of acrylonitrile or methacrylonitrile
monomers. These provide for packaging of those products which are not packed in usual packages as they
provide for high gas barrier, good chemical resistance, and good strength.
8. Polyethylene terepthalate (PET): Condensation polymer formed by reaction of terepthalic acid or
dimethyl terepthalic acid with ethylene glycol. It has excellent strength and provides barrier for gas and
aroma making it as a useful package for cosmetics, mouth washes and other products. While there are
different packaging materials approved by FDA for packaging it has to be known that FDA doesn’t
approve the container but its material that is being used. A list of substances considered by FDA are
published as, “Generally recognized as safe (GRAS)”. It’s responsibility of manufacturer to prove the
safety of a packaging material and to get an approval from FDA.
Packaging technology and its role in counterfeit actions:
Role: 1. To stop the product mimic in market
To maintain the brand value
To minimize the losses .
Maintain integrity, stability, and purity of the content.
Various type of the counterfeit actions that can be performed with advance packaging options:
1. Ink technology: Technique allows color to reappear when rubbed or scratched. E.g. "Secur"
labels, Ad Tape & Label.
2. Radio-frequency identification (RFID): RFID is another technology with anti-counterfeiting
potential. RFID tags can help authenticate products and support data collection for pedigree
records. Equipment that encodes and prints tag-equipped labels verifies the tag before and after
encoding. If a nonviable tag is detected before encoding, the label is marked with a checkerboard
pattern and ejected. Good labels are encoded and rechecked for their surety.

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Radio-frequency identification (RFID) tagging helps to simplify shipping, receiving, inventory
location, and control has been mandated by the department of defense, several other retailers, and
various hospitals.
3. Tamper-evident stickers: Needs a special substrate designed for the purpose. The cellulose
acetate film is very intricately designed so that it has adequate strength to undergo conversion
into label stocks in roll form. The stickers can be automatically dispensed on automatic label
dispensers and when attempted to be removed these break-up into very small pieces. Vinyl had
now replaced acetate film being cost effective.
4. Holographic materials: Large and important part of the security label market and are an ideal
choice for product authentication. The holographic foil an optically variable device is usually
made using a polyester film base. The perception of the holographic image by the human eye
makes it ideal for brand promotion and security. Packages reveal the holographic image when
tilted against light source. By increasing the complexity of hologram manufacturer can make it
difficult for counterfeiters to duplicate the products. Many holograms besides offering brand
authentication also offer tamper evident properties.
5.Child resistance packaging Child resistant packaging is essential criterion for highly potent
pharmaceuticals. New child-resistant (CR) blister are designed to offer improved peel ability and
printability while establishing protective qualities that prevent children from accessing the drugs.
Q How packing is helpful for the patient/ target?
Ans: Dispensing accuracy & Promotion of patient compliance with product dosage schedules
Majority of compliance designs are based on blister cards. E.g., "Helidac Therapy Kit" from is a
multi pill frequent-cycle regimen used to treat the Helicobacter pylori infections responsible for
most stomach ulcers. The kit organizes the regimen into 14 daily-dose blister cards, each divided
into four doses . So dose differentiation and categorization can be done with the help of the
packaging.
Also packaging can be informative in terms of its use and and adverse actions. The cartons
contains the leaflets which are informative for the patients to know abt the drug.
Advancements:
Self talk packs in Europe
The “Talk Pack ” from Wipac Walsrode (GmbH in Germany), is a system, which can be
invisibly integrated into any printed image on any packaging material, but needs a special
scanning pen a development by VTT Technical Research Centre of Finland. It involves special

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pen-shaped reader used to retrieve the stored information and to replay it as audio version of
information for the product and its manufacturer.
VTT Technical Research Centre: NFC tags - VTT Technical Research Centre NFC tags are
added to any packaging so a consumer could touch the code on the packaging with their NFC-
Eco-friendly pharma packaging:
The pressure to develop sustainable, eco-friendly products is pressurizing packaging industry and
has even begun to affect pharmaceutical packaging, one of the industry's most complex sectors.
The development of sustainable packaging is a difficult task for companies serving the
pharmaceutical industry - environmental considerations must not lead to any compromise on a
package's safety or accessibility.
Ecoslide-RX introduces industry with environmentally balanced formulation of packages. The
pack is made from 100% recycled material, using unbleached paperboard and a clay-coated
surface designed to house blister packaging with a minimum of unsustainable film and foil. The
slide package meets all the modern expectations for child-resistance and accessibility for seniors,
but doesn't require heat sealing in the manufacturing process, reducing both costs and energy
usage
Syreen prefilled syringe design: Instead of glass, cyclic olefin polymer (COP) is used in syreen
syringes where COP provides secondary packaging altogether. Packed syringes can be clipped
into places provided this eliminated need for packaging materials like cardboard and Styrofoam.
Overall packaging leads to reduction in product cost, better stability, good patient compliance.