PHARMACEUTICAL PACKAGING

DEPARTMENT
Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for
pharmaceutical preparations. It involves all of the operations from production through drug
distribution channels to the end consumer.
The following are four main functions of advanced pharmaceutical packaging:

• Containment –

Containment is the most fundamental function of packaging for pharmaceutical

products. Packaging design must take into account the needs of the product, as well as the
manufacturing and distribution system. This requires the packaging to not leak, nor allow diffusion
and permeation of the product; to be strong enough to hold contents under normal handling; and not
be altered by the ingredients of the formulation.

• Protection –

The packaging must protect the product against all adverse external influences that
may affect is quality or potency – such as light, moisture, oxygen, biological contamination, and
counterfeiting.

• Identification and Information –

Printed packaging serves the functions of providing both

identification of and information on medicinal products. Information normally included on
pharmaceutical labels can include usage instructions, dosages, potential side effects and
manufacturing dates.

• Convenience - Convenience is associated with product use or administration.

Types of Packaging:

Packaging in the pharmaceutical industry varies from drug to drug and normally there are three
levels of packaging commonly referred to as the primary, secondary, and tertiary packaging.

1. Primary packaging system is the material that first envelops the product and holds it i.e., those
package components and subcomponents that actually come in contact with the product, or those
that may have a direct effect on the product shelf-life e.g., ampoules and vials, prefilled syringes, IV
containers, blister packs, etc.

2. Secondary packaging system is outside the primary packaging and used to group primary
packages together e.g., cartons, boxes, shipping containers, injection trays, etc.

3. Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container, edge
protectors, etc.

Primary Packaging

• The packaging that most closely touches a product, often referred to as “retail packaging.”
• Its main goals are to protect the product and inform or attract a customer.
• What’s considered to be primary packaging depends on the product. For example, a pop can is
primary packaging (because it’s the primary way to carry around soda), while a corrugated box
containing a camera and its accessories is also primary packaging (because it’s the primary way to
purchase it).

Types of Primary Packaging:

i. Bilister Packs
ii. Strip Packaging
iii. Ampoules
iv. Vials
v. Bottles
vi. Sachet Packagin

Secondary Packaging

• The packaging used to ship products already in primary packaging.

• Its main goals are to protect products and provide branding during shipping.
• It’s also used as display packaging in retail locations such as grocery stores.
• Examples of secondary packaging include 12-packs of soda cans, the corrugated box that a
half-dozen camera boxes ship in, and the display stand for a newly-released Blu-Ray movie.
• As you can see, primary and secondary packaging sometimes overlap.
• Secondary packaging can overlap with tertiary packaging as well.

Tertiary Packaging

• The packaging used most often by warehouses to ship secondary packaging.

• Its mail goal is to properly protect shipments during their time in transit.
• Tertiary packaging is typically not seen by consumers.
• Examples include the pallets that bulk shipments are placed on, corrugated pads used to separate
layers of boxes and stretch wrap used to secure stacks of cartons.

Steps to Improve Pharmaceutical Product Packaging:

i. Compliance with Product Regulation

ii. Business Process to Support Packaging
iii. Automation of Packaging and Labeling
iv. Optimization of Pharmaceutical Product Packaging.

Types of Packaging for Tablet and Capsule:

1. Blister package
2. Strip package
3. Alu-alu packaging
4. Bottle packaging

1.Blister Package:

Blister packs are commonly used for unit dose packaging for tablets and capsules. The principal
components of a blister pack comprise of :
1. Forming film (blister): A pocket inside which the product fits and
2. Backing
Automatic Blister Packaging Machine:

Parts of Blister Machine:

1.Alu Forming set

2.Forming bottom
3.Sealing top
4.Sealing bottom
5.Slitter
6.Perforation set
7.Punce set
8.Guide rail set
9.Manual feeder
10.Drop
11.Pack size

Steps involved in the formation of a blister:

i. Thermoforming: This involves heat softening a sheet of thermoplastic resin and then vacuum
drawing the softened sheet of plastic into a mold. After cooling, the sheet is released from the mold.

ii. Filling: The sheet then proceeds to the filling station for filling.

iii. Sealing: Sealing is then accomplished by lidding it with a heat sealable backing material.

2. Strip Package:

Strip package is formed by feeding two webs of a heat sealable flexible film through a heated
crimping rollers. This package is used for both capsules and tablets.
Materials used:
● Foil laminations (for moisture sensitive products)
● Paper
● Polyethylene
● Cellophane (Transparent plastic film formed from processed cellulose.
Steps involved in the formation of a strip package:
i. The product is fed into the pocket formed between two heat sealable flexible films.
ii. Sealing is accomplished by heat crimping rollers
iii. The strip is then cut into desired no. of packets in length

3. Alu-alu Packaging

Alu-alu packing means aluminium foil at both the upper and lower side of pack. Alu- alu packaging
is similar to that of blister packing the only difference is that the forming film is formed of
aluminium foil instead of plastic material.

4. Bottle Packaging:

Bottles are commonly used for liquid pharmaceuticals as well as for tablets and capsules.
Materials used:
Bottle:
● Polyethylene
● Polypropylene screw cap
● Polystyrene
Bottle mouth seal:
● Aluminium foil

Packaging of Powders:

Pharmaceutical powders are solid dosage forms of medicament in which one or more drugs are
dispensed in finely divided state with or without excipients. They are available in crystalline or
amorphous form.

Powder packaging-

• Pouches
• Bottles(dusting powder)

PVC & PVDC:

PVC(Polyvinyl chloride) and PVDC(polyvinylidine chloride)are used in pharmaceuticals

as primary packaging materials,which protect pharmaceutical product against Oxygen and
odour permeation,moisture and water vapour transmission and microbial attack.
DOCUMENTATION
Packaging material for liquid dosage forms documentation.

Documentation:

The main purpose of documentation is to define procedures in written to the pharmaceutical

manufacturer so as to minimize the errors, misinterpretations due to oral or casually written
communication and to allow the tracing of historical batches which eventually leads to the quality
of the product.

Purpose of the document:

The purpose of a document is to facilitate the transfer of information from its author to its readers. It
is the author's job to design the document so that the information it contains can be interpreted
accurately and efficiently. To do this, the author can make use of a set of stylistic tools.

Types of pharmaceutical documents:

To ensure that this is accomplished, below are some of the most common types of documents that
are required:
• Quality assurance documents - Outlines the company's own Standard Operating Procedures
(SOPs) and regulations.
• SOP documentation.
• Batch records.
• Specifications listing.
• Logbooks.

Good documentation practices in pharmaceutical industry:

• In the context of these guidelines, good documentation practices are those measures that
collectively and individually ensure documentation, whether paper or electronic, is secure,
attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.

Importance of Documentation:

Documentation is important because the accurate capture of information plays a vital role in the
pharmaceuticals and medical device industry. Documents are a Mirror to show actual image of any
pharmaceutical company. Effective documentation enhances the visibility of the quality assurance
system.

Record

Documentation and records are used throughout the manufacturing process, as well as Supporting
processes (e.g. Quality Control or Quality Assurance), must meet the basic Requirements of Good
Documentation Process.
These include (but are not limited to):
1. Batch Record Forms
2. Bills of Materials (BOMs)
3. Specifications
4. Policies
5. Protocols
6. Standard Operating Procedures (SOPs)
7. Work Instructions (WIs)
8. Checklists
9. Forms/Log sheets
10. Certificate of Analyses or Certificate of Compliance
11. Technical transfer reports
12. Technical agreements
13. Technical reports
14. Test Methods
15. Training Assessments
16. Records
17. Worksheets, note books, and log books
18. Validation documentation
19. Manufacturing and packaging instructions
20. Confidentiality agreements
21. Change control
22. Quality system related documents
23. Quality manual
24. Validation protocols and report
25. Deviation reports
26. Audit plans

Batch Manufacturing Record

Batch manufacturing record (BMR) is an important document for chemical and process
manufacturers: It tells users how to produce a batch of a given product, then records the entire
production process, from start to finish. What are the different parts in batch manufacturing record?
A good batch manufacturing record format should include following parts:
• Batch records.
• Bill of Material.
• General instruction for manufacturing.
• Equipment cleaning record.
• Yield.
• Abbreviations.
• History of Chances.

Importance of Batch Record

A batch record is important because batch records indicate that the batch conforms to the current
Good Manufacturing Procedures (GMP). The batch record also contains specific information about
the product tested, analytical methods, and test results.