Pharmaceutical Packaging, Medical device packaging, Enteral Packaging, Aseptic Packaging System, Issues facing modern drug packaging.

1. Pharmaceutical
packaging
Prepared by
Bhumi P. Suratiya
M.Pharm (Sem-I)
Guided By
Dr. Dhara Patel
(M.Pharm, PhD)
(Associate professor)
Pharmaceutical Quality Assurance
Pioneer Pharmacy Degree College, Vadodara

2. Contents
Introduction
Medical device packaging
Enteral packaging
Aseptic packaging systems
Issues facing modern drug packaging
2

3. Introduction[1]
 Packing: Packing consists of enclosing an individual item, or
several items, in a container, usually for shipment or delivery. This
operation is mostly done by hand and machine.
 Pharmaceutical Packaging: Pharmaceutical packaging means
the combination of components necessary to contain, preserve,
protect & deliver a safe, efficacious drug product, such that at any
time point before expiration date of the drug product, a safe &
efficacious dosage form is available.
3

4. Medical Device Packaging
[Photo]
‘4

5.  Definition:- According to the World Health Organization, a medical device can be
any instrument, apparatus, implement, machine, appliance, implant, reagent for in
vitro use, software, material or other similar or related article, intended by the
manufacturer to be used, alone or in combination for a medical purpose.
 Medical devices can be sterile or non-sterile.
Medical Device Packaging[2]
Surgical Plates Knee Implants
5

6. Medical Device Packaging Should be: [3]
Non-toxic, non-leaching and odourless
Made of known and traceable materials
Free of holes, cracks, tears, creases and localized thinning
Intended for use in medical applications
It must also allow sterilization
Allow aseptic environment to the medical device
Provide physical protection to the device
Maintain sterility up to the point of use of medical device
6

7. Types of Packaging[4]
 There are many types of packaging materials that can be used for both sterile and
non-sterile medical devices.
The material which comes in direct contact with the medical devices is
known as primary packing material.
The material which comes contact with the primary pack is called
secondary packing .
This may be a paper/cardboard box.
For the bulk storage and for transportation tertiary packing system
can be used, this may be a carton box.
7

8. The 6 Most Common Packaging Platforms for
Medical Devices[5,6]
 Type of devices that don't require a high level of product protection like,
 pouches
 bags
 films.
 Then packaging platforms used to enhance the protection of medical devices
 laminations,
 die cut lids,
 thermoformed trays.
8

9.  Pouches are low cost packaging options that allow for massive
volume and quick lead times, which means they mostly remain
relegated to commodity products.
 They can be stacked, thrown, flipped and sling-shotted around
without adding much risk to the budget or supply chain.
 Best of all: Pouches can be mixed and matched with various
materials to suit any low cost device.
2. Bags
1. Pouches
 Medical bags are another low-cost platform that provide
superior opening options when compared to a basic tear pouch.
Something as simple as a resealable opening, like a “ziplock” or
mild adhesive, can add tremendous value to the end user.
9

10.  Polyurethane films are used industry-wide to protect
prosthetic implants, surgical screws and other medical devices
that need to be malleable and durable over the long term.
 Combined with breathability, flexibility, and durability,
forming films have everything you need to keep your device
safe and sterile at a relatively low cost.
3. Films
4. Laminations
 Laminations are composed of two or more individual films that
are used within the structure of a medical pouch or bag.
 Each film adds an extra layer of protection, such as UV,
moisture, or corrosion barriers.
 Another benefit in using a stack of high-quality laminations is
that most of the films are impermeable by gas, which enables
their use as packaging for sterile products. 10

11. 5. Die Cut Lids
 During a medical procedure, the end user must be able to open
the device’s package without disturbing the contents inside. The
die cut lid rises to that challenge.
 This platform’s rigid structure, typically shaped as a tray, allows
for a form that holds the device in place. “Clean peel”
technologies then ensure a clean and particulate-free opening
motion.
 Thermoforming is an excellent protective and cost effective
packaging platform.
 Many medical device designers choose thermoformed packaging
due to it’s high impact resistance, glass-clear transparency, and
its wide range of design and barrier options.
6. Thermoform Trays
11

12. The Types of Tests Carried out for Medical Device
Packages are as Follows: [7]
I. Sterilization Methods
II. Barriers
III. Material Performance
IV. Packaging Process
 The correct packaging materials have to be chosen based on the product
requirements such as sterilization method or if it is moisture or oxygen sensitive.
 A packaging system, sterile or non-sterile, must be validated and verified to
demonstrate it can withstand transportation hazards and climate conditions.
12

13. I. Sterilization Methods
 The sterilization method will affect the type of packaging materials that can be
used for the sterile product.
 Different sterilization methods include:
 Gamma Irradiation,
 Ethylene Oxide (EtO)
 Electron Beam (E-Beam)
 Autoclave.
13

14.  For products that require gamma sterilization, the packaging
materials need to be breathable to allow for sterilization, but
also protect the product from microorganisms.
 Common packaging components that can be used for gamma
sterilization are Tyvek pouches, Nylon pouches, and
PETG(polyethylene terephthalate glycol) trays with Tyvek lids.
 Ethylene Oxide is a gas that can leave residuals that can be
very harmful if it is not evacuated/aerated properly. When
designing for EtO sterilization, label placement and
IFU(instruction of Use) placement is very important as these
items could block sterilization and/or block evacuation of
residuals.
 The packaging materials used for gamma can be used for EtO
as well.
I. Sterilization Methods
Ethylene Oxide Sterilization
Chamber
14

15. III. Material Performance
 Some medical devices require an oxygen or moisture barrier.
 It is important to understand the product and what type of
barrier is needed.
 If the incorrect packaging material is chosen, the product may
corrode or become contaminated.
II. Barriers
 It is important to understand how the packaging will behave
after a certain amount of years under certain climatic conditions.
 This can be evaluated by conducting an Accelerated Aging (AA)
test accompanied by a Real Time (RT) Aging test. Over time,
seals can soften and loosen up.
 This can cause the material to delaminate or even change colors.
 Today, packaging materials should be able to maintain stability
for up to 10 years in normal hospital surgery center climate
conditions. 15

16.  Once a packaging system has been selected and
verified, it is important to have the correct sealing
equipment for assembly in the production
environment.
 The correct sealing parameters must be validated as
well to ensure a good seal is produced every single
time no matter if you are sealing pouches or rigid
trays.
 The strength of seal cannot be too great to where
the customer or end user cannot open the sterile
barrier pouch or tray.
IV. Packaging Process
Rigid Tray Sealer
Bar Heat Sealer
(Use For Pouches) 16

17. Enteral Product Packaging
17

18. Enteral Product Packaging[8]
 Packaging of an enteral product in cans and glass bottles uses the same techniques
and process as other consumer products in the same packages.
 The package must be able to withstand the sterilization or processing of product and
also must be able to protect all of the food components from degradation over an
extended period of time.
 Packaging, processing, and the product itself are inextricably linked in providing
enteral nutrition to critically ill patients.
 Medical nutritional products come in two forms, powders or liquids.
 The type packaging used for medical nutritional products include metal cans, glass
bottles, plastic bottles, plastic films, pouches, and laminated multilayer plastic
structures.
18

19. Aseptic Packaging System
19

20. Aseptic Packaging System[9]
 Aseptic packaging can be defined as the filling of a commercially sterile product
into a sterile container under aseptic conditions and hermetically sealing the
containers so that reinfection is prevented. This results in a product, which is
shelf-stable at ambient conditions..
 Aseptic packaging is the process by which microorganisms are prevented from
entering a package during and after packaging. During aseptic processing, a
sterilized package is filled with a commercially sterile food product and sealed
within the confines of a hygienic environment.
 The term “aseptic” is derived from the Greek word “septicos” which means the
absence of micro-organisms.
20

21. Objectives of Aseptic Packaging
To sterile the product that provide the higher
quality product
To take advantage of high temperature short
time(HTST)
To extend the shelf life of products at normal
temperature by packaging them aseptically
21

22. Process Flow
22

23. Aseptic Processing – Methodology
Sterilisation of the products before filling
Sterilisation of packaging materials or containers and
closures before filling
Sterilisation of aseptic installations before
operation(Equipment Sterilisation)
Maintaining sterility in this total system during
operation, sterilization of all media entering the
system, like air, gases, sterile water
Production of hermetic packages
23

24. Sterilization of Products
 In aseptic processing, the design to achieve commercial stability is based on the
principles of thermal bacteriology and integrated effect of time/temperature
treatment on spores of micro-organisms.
• 63℃ /30 sec
• 72℃/15 sec
HTST*
• 130℃-150℃/fraction
of sec
UHT*
*HTST(High-Temperature,
ShortTime)
*UHT(Ultra-High Temperature)
UHT and HTST are two methods that
involve heating liquid product to a
specific sterilization temperature for a
precise, short time, followed by rapid
cooling before packaging. 24

25.  Sterilisation Agents: Heat, chemicals and radiation have been used, alone or in
combination, for sterilization of aseptic equipment and packaging materials.
Sterilisation of Aseptic Packaging
Materials and Equipment
• Moist Heat: 121℃-129℃
• Dry Heat: 176℃-232℃
Heat
• Hydrogen Peroxide: at concentration of 30
to 35%
Chemicals
• Gamma radiation :1.5 megaradians (Mrad)
• UV light
Radiation
25

26. Packaging Materials
 Tetra Pak aseptic cartons are made of three basic materials that together result in a
very efficient, safe and light-weight package. Each material provides a specific
function
 Paper (80%): to provide strength and stiffness
 Polyethylene (15%): to make packages liquid tight and to provide a barrier to
microorganisms
 Aluminium foil (5%): to keep out air, light, and off-flavours - all the things
that can cause product to deteriorate
j26

27. Composition of Tetra Pak Aseptic Carton
27

28. Aseptic Packaging System
Bottle system
Sachet and pouch
system
Cup system
28

29. Aseptic Packaging System
 A great variety of packages may be aseptically filled now as listed.
 Carton Boxes
 Bags and Pouches
 Cups and Trays
 Bottles and Jars
 Metal Cans
 Plastic Cans
 Composite Cans
29

30. Benefits of Aseptic Packaging
Shelf stability at ambient temperatures.
Extends shelf life.
No preservatives needed.
Gentler, shorter processing.
Lighter weight and compact.
More eco-friendly.
Beverages.
Food.
30

31. Issues Facing Modern Drug
Packaging
31

32.  Packaging is not only protecting the drug from degradation but
also contamination; it will become an important part of drug
delivery system.
 Moreover, smart pharmaceutical packaging depends on the nature
of the drug, dosage form, route of administration, supply chain,
and shelf life of the product.
 The pharmaceutical packaging industry, owing to the sensitive
nature of products, also faces a lot of challenges.
 Poor packaging can cause chemical alterations in the product
damaging their curative ability and ineffective performance.
Issues Facing Modern Drug Packaging[10]
32

33. Here are some Common Challenges of the
Pharmaceutical Packaging Industry: [10,11]
1. Environmental Issues of Packaging Materials
2. Safe Transportation of Non-solid Medication
3. Retaining Medicinal Quality of the Products
4. Accurate Dosage And Drug Information
5. Newly Developed Drugs Conflicting With Packaging Material
6. Averting Forged Products
7. Adhering To Regulatory Standards
8. Awareness And Education of Medical Practitioners and Consumers
33

34. 1. Environmental Issues of Packaging Materials
 pharmaceutical package waste generated in the pharmaceutical industry and affected the
environment.
Material Use Environmental impact
Glass Ampoules, vials, syringe, cartridge Production of harmful greenhouse gases and it affects the ozone
layer present in the stratosphere and produces global warming
Plastic Carton, bags, wrappers, pouches,
bottles, containers, caps, and pellets
Tend to affect the groundwater, plants, and aquatic life. Harmful
chemical enter into the body and interrupt the food chain
Paper Labels, package inserts, boxes,
liners, linings, and wrapping
materials
Printing inks present in the cartons release zinc, lead, barium,
copper, and discharge of chlorine by bleaching the paper into
drinking water will produce fertilization problems
Metal Collapsible tube, shallow drums,
aerosols, closures, and inhalers
Burning of packaging materials generate dioxin, tributyrin, and
heavy metals produces carcinogenic substances
Aluminim Strips packs, collapsible tubes, and
blister packs
Scarcity of natural resource utilizing trees for papers and bauxite
ore for aluminum production
Rubber Closures Polystyrene is vinyl benzene, impair central nervous system34

35.  Paper bag = 1 month
 Plastic bag = 10-20 years
 Tin can = 80-100 years
 Aluminum can = 500 years
 Glass bottles = 1000 years
 Plastic = A long time
Time frame of packaging materials to
decompose
35

36. 2. Safe Transportation of non-solid Medication
 While tablets, capsules and pills are
comparatively simpler to handle due to their
ability to be stacked.
 Liquid medication and injections, especially
with glass packing are much more difficult to
handle because of their fragile nature.
 The integrity of glass vials recently came to the
attention of the FDA and another manufacture.
36

37. 2. Safe Transportation of non-solid Medication
 To try and counter this problem, the pharmaceutical
packaging industry is integrating innovative
solutions like foam packaging and rotomolded
cases to glass cases from breaking down.
 Eventually, the glass bottle was overshadowed by
the plastic model, as it was much easier and less
expensive to transport plastic safely.
 Plastic bottles were considered to be more
lightweight, resistant to breakage, and therefore
superior in every way when compared to glass
bottles.
37

38.  One of the major challenges that the
industry faces is due to sustained
exposure to heat as well as humidity,
the product may lose its healing
capabilities, rendering the product
completely useless.
 The pharmaceutical packaging
materials must be chosen very
carefully and should not let external
factors affect the product.
3. Retaining Medicinal Quality of the Products
38

39.  Any medicine must be consumed according to the
prescribed dose.
 To avoid any confusion, it is imperative that the
necessary dosage information, as well as the drug
that it is composed with, must be present on the
packaging of the product itself.
 Further, other valuable information such as expiry
date and the serial or batch number to simplify
tracking should also find a place on the packaging.
 It is also necessary to point out parameters like a
minimum age for safe consumption of the drug.
4. Accurate Dosage and Drug Information
39

40. 5. Newly Developed Drugs Conflicting With
Packaging Material
 As the pharmaceutical industry witnesses
development of innovative and new-age drugs,
many of them are often in conflict with the
materials being used to packaging them.
 For example, there are certain drug combinations
that lead to flaking of glass packaging.
 Another such example is when silicone oil being
used in prefilled syringes to lubricate the plunger
in. The lubricant often disturbs the composition of
the protein complexes. This has led to the need for
newer pharmaceutical packaging materials.
40

41. 6. Averting Forged(duplicate) Products
 With so many products from a variety of brands flooding the market, it is not
surprising that duplicate drugs are also on the rise.
 The danger of these drugs cannot be underestimated because of the potential
side effects they might have on the customer.
 In order to prevent this major problem, pharmaceutical packaging is an
important aspect.
 Research and innovation in this domain has led to increase in scannable codes,
hologram stickers, UV prints that ensure that official products stand apart from
the fake ones.
41

42.  A pharmaceutical company may be selling the same product under
different names in different markets.
 As the companies produce those drugs on a single Process line, the
task of printing, labeling, and packaging becomes complicated.
 Label requirement
 Name of the product
 Name and quantity of each active ingredient
 Name and address of the manufacturer
 Registration number of the product
 Batch number
 Pack insert
 Expiry date and Storage conditions.
7. Adhering to Regulatory Standards
42

43. 8. Awareness and Education of Medical
Practitioners and Consumers
 Consumer needs to be aware about what is inside the packaging, how to use the
product and how to dispense it.
 If a person takes a wrong medicine or improper dosage, it can have a severe effect
on their health, sometimes fatal.
 Thus, proper direction of use needs to be printed on the packaging in order to
ensure safe and secure use of the medicine.
43

44. 1. Dr. Basavaraj N., “Packaging and Stability Requirements for Pharmaceuticals”.
Accessed on 26-01-2023, Packaging and stability requirement for pharmaceuticals.
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https://www.cleanroomtechnology.com/news/article_page/Selection_criteria_for_me
dical_device_packaging/103904
4. Medical Device Packaging, accessed on 26-01-2023,
https://www.i3cglobal.com/medical-device-packaging
References
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45. 5. Bulchandani H., “PHARMACEUTICAL PACKAGING, COMPONENT AND
EVALUATION", accessed on 26-01-2023,
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pdf
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https://www.toplastics.com/blog-medical/medical-device-packaging-options
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http://packcon.org/index.php/en/articles/117-2021/291-medical-device-packaging
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https://www.slideshare.net/rishitiwari42/pharmaceutical-packaging-
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References
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46. 9. Pritam K., “Aseptic Packaging”. March 2021,accessed on 27-01-2023
https://www.slideshare.net/PritamKolge/aseptic-packaging-244842771
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https://www.meghmaniglobal.com/7-key-challenges-in-pharmaceutical-packaging
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46

47. Thank you
47