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4.6 Filtration Devices
4.6.1 Filter Leaf Assembly
Design Features Filter leaf assembly is composed of a chamber containing one or
several “lter leaves” sequentially arranged. Each lter leaf is composed of a
grooved plate or mesh surrounded by a frame of any shape. The grooved plate and
frame are surrounded by a lter cloth. The leaves are connected to a common outlet
for ltrate.
Operational Mechanism The feed is supplied to the chamber. The lter leaves are
dipped in the feed. Pressure is applied to the chamber, as shown in Fig.4.2. Due to
pressure difference (typically ~8 bars), the liquid passes through the lter cloth,
enters the troughs of the plate, and eventually passes through the frame (channel) to
the outlet [8]. The solid residue is retained on the lter cloth. The lter leaves are
washed by immersion in water or by the application of reverse airow.
Table 4.2 Types of lter media [3]
Type Examples
Woven type Filter cloth
Function as surface-type medium
Made of natural, synthetic bers or metals
Cotton is the most commonly used material
Nylon is superior for pharmaceutical use (no microbial growth, smooth
surface, and negligible absorption properties)
Teon is superior (chemically inert, strength and high temperature)
Wire mesh (stainless steel)
Durable, resistant to plugging, and easily cleanable
Good surface lter for cake ltration
Installed in lling lines of packing equipment
Nonwoven
type
Felt
Fibrous mass mechanically interlocked
Function as depth lter
Recommended for gelatinous solutions or slurry of ne particles
Bonded fabrics
Binding of textile bers with resins, solvents, and plasticizers
Not widely used in pharmaceuticals
Kraft paper
Usually used in plate and ame lters
Offers controlled porosity, limited absorption characteristics, and low cost
Support of cloth or wire mesh is necessary
Membrane lter
Thin membrane (usually, 150μm thick, 400–500 million pores per square
centimeter)
Prelteration is needed to avoid clogging
Made of various esters of cellulose or from nylon, Teon, PVC, polyamide,
polysulfone, or silver
Pore size depends on particles to be removed (0.2μm is used for sterile
lteration)
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4.6.2 Filter Press
Design Features The typical assembly consists of grooved plates, hollow frames,
and lter medium (i.e., usually a cloth or lter paper) sandwiched between plates
and frames, as shown in Fig.4.3. A common inlet connects all the frames and the
plates are connected to a common outlet [9]. The pressure gauge on the plates is
used to monitor the pressure of ltration. The plates and frames are made up of met-
als, plastics, and sometimes from wood. The wooden plates and frames are kept wet
to prevent shrinkage and de-shaping.
Operational Mechanism The plates and frames are set alternatively in a sequence;
lter medium is placed in between them. The feed enters the frames via an inlet
Fig. 4.2 Leaf lter and its
internal structure.
(Courtesy: MBL Group,
Malaysia)
Fig. 4.3 Mechanism of ltration through lter press (www.parksanlters.com)
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channel and moves through the lter medium into the plates, where it drains down
through the groves to the outlet channel of the plates, which then opens into a com-
mon outlet. The lter cake is deposited in frames. Filtration is continued until the
frames are entirely occupied by lter cake [10]. As the ltration process extends, the
rate of ltration decreases, since the resistance of the cake increases. When ltration
rate is substantially lowered, it is preferred to stop ltration operation and remove
the cake, rather than continuing the process at very low ltration rate.
4.6.3 Disc Filter Assembly
Design Features It comprises a number of grooved plates and hollow frames. Filter
media (circular disc shaped) is sandwiched between plates and frames that are verti-
cally xed on a central column which has a channel at the circumference. Felt is
frequently used as lter media and is usually disposable. The entire housing is
closed into a pressure casing. The frames have small holes at the sides that function
as inlet for uid, as shown in Fig.4.4. Disc lter is compact, portable, and easily
cleanable. However, it is mainly used for clarication purpose.
Operational Mechanism When the feed is introduced into the assembly with
pressure, it enters the frames through peripheral holes and subsequently passes
through lter media. The ltrate moves through the grooved plates and is directed
toward the channel at the circumference of the vertical column. The ltrate drains
down the channel to the outlet.
Fig. 4.4 Disc lter assembly internal view (www.parksanlters.com)
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4.6.4 Rotary Drum Filter Assembly
Design Features It consists of several rectangular units having a perforated curved
surface, all joined together to form a drum. When rotated, the segments pass through
various zones in a continuous succession [11]. A lter cloth covering the surface
serves as lter medium. All segments are joined to a rotating duct at the center of the
drum (shown in Fig.4.5). It is mainly used for cake ltration, hence also called
rotary drum dryer.
Operational Mechanism The lower surface of the drum is dipped into the slurry.
This zone is called pick-up zone or ltration zone. As the drum is rotated the solid
is deposited on the surface while the ltrate drains down the segments into the cen-
tral rotating outlet [12]. In washing zone, a shower of water washes the cake at the
surface of the drum, and after washing it is subjected to drying (drying zone). The
dried cake is usually scraped with sharp knives (removal zone).
Some ltration operation might need special considerations, for instance, if the
cake shrinks upon drying, it is slightly compacted with the help of compression roll-
ers in order to ensure efcient washing. Similarly, scrapers for removal of cake
might occasionally pose problems; a string discharge is added. The cake is formed
over the strings that is detached when the strings pass through small rollers to get a
sharp bend, thus releasing the cake from the surface.
Advantages It has large surface area and offers continuous ltration. The speed
can be varied according to the thickness of the cake.
Limitations The equipment is complex and expensive. It is less effective for sol-
ids of impermeable cake.
Fig. 4.5 Rotary drum lter (www.nfm- lter.com)
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4.6.5 Bag Filter Assembly
Design Features It consists of a nylon bag held in a stainless steel or high-quality
plastic cage that is enclosed in a stainless-steel housing.
Operational Mechanism The feed is introduced from the top into the lter hous-
ing, it passes through the lter bag, the cake (residue) is left in the bags, and the
liquid (ltrate) drains down to the outlet, as shown in Fig.4.6.
4.6.6 Cartridge Filter Assembly
Design Features It utilizes cartridges for ltration. Cartridges are made with dispos-
able or cleanable lter media that is either string wound or pleated wound on a
plastic hardware [13]. The receptacles (cavities) in the base of the housing hold
many cartridges, as shown in Fig.4.7.
The cartridge size, the housing design, and the construction material depend on
the intended application. Cartridge lters are mainly used for ltration of water.
Operational Mechanism Feed enters through the inlet at the side of the housing;
it passes through the thick layer of lter medium into the central tube of the car-
tridge and subsequently drains down to the receptacles at the base of the housing
that leads to a common outlet.
Fig. 4.6 Bag lter
assembly (
www.
waterdroplters.co.za
)
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References
1. Nagy B, Szilágyi B, Domokos A, Tacsi K, Pataki H, Marosi G, etal. Modeling of pharma-
ceutical ltration and continuous integrated crystallization-ltration processes. Chemical
Engineering Journal. 2021;413:127566.
2. Kahshan M, Lu D, Abu-Hamdeh NH, Golmohammadzadeh A, Farooq AA, Rahimi-Gorji
M.Darcy-Brinkman ow of a viscous uid through a porous duct: Application in blood ltra-
tion process. Journal of the Taiwan Institute of Chemical Engineers. 2020;117:223–30.
3. Khar RK.Lachman/liebermans: the theory and practice of industrial pharmacy: Cbs Publishers
& Distribu; 2013.
4. Tien C.Principles of ltration: Elsevier; 2012.
5. Aulton M, Taylor K.Aulton's pharmaceutics: the design and manufacture of medicines. 2013.
Elsevier Health Sciences.
6. Sparks T, Chase G.Section 7 - Filter Selection, Process Design, Testing, Optimization and
Troubleshooting Guidelines. In: Sparks T, Chase G, editors. Filters and Filtration Handbook
(Sixth Edition). Oxford: Butterworth-Heinemann; 2016. p.383–413.
7. Harcum S. 2– Purication of protein solutions. In: Abbott A, Ellison M, editors. Biologically
Inspired Textiles: Woodhead Publishing; 2008. p.26–43.
8. Prager G.Practical Pharmaceutical Engineering: Wiley Online Library; 2019.
9. Guerrini L, Masella P, Migliorini M, Cherubini C, Parenti A.Addition of a steel pre-lter
to improve plate lter-press performance in olive oil ltration. Journal of Food Engineering.
2015;157:84–7.
10. Civan F.Chapter 12 - Cake Filtration: Mechanism, Parameters and Modeling. In: Civan F,
editor. Reservoir Formation Damage (Third Edition). Boston: Gulf Professional Publishing;
2016. p.295–341.
11. Liu X, Hu Z, Wu W, Zhan J, Herz F, Specht E.DEM study on the surface mixing and whole
mixing of granular materials in rotary drums. Powder Technology. 2017;315:438–44.
12. Rotary drum vacuum lter for small-scale industrial processes or pilot trials. Filtration &
Separation. 2004;41(8):14.
13. Cartridge lters target applications where the cost of ltration is critical. Membrane
Technology. 2021;2021(5):4.
Fig. 4.7 Cartridge lter
assembly (
www.
qmstainless.com
)
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55© The Author(s), under exclusive license to Springer Nature Switzerland AG 2022
S. A. Khan (ed.), Essentials of Industrial Pharmacy, AAPS Advances in the
Pharmaceutical Sciences Series 46, https://doi.org/10.1007/978-3-030-84977-1_5
Chapter 5
Pharmaceutical Packaging
FawadAli andInzemamKhan
Abstract Packaging is one of the major sections of the pharmaceutical industry.
The role of packaging evolves from time to time due to the new regulatory guide-
lines and scientic developments. Each product possesses unique properties.
Depending upon the product characteristics, the packaging material may differ from
product to product. The choice of the packaging material also depends upon how the
drug is produced, transported, and stored. The basic purpose of packaging is to pro-
vide efcacy, safety, uniformity, and purity and minimize impurities to comply with
the standards. This chapter presents sound knowledge about pharmaceutical pack-
aging, most importantly the different types of material used in packaging of
pharmaceuticals.
Keywords Primary packaging · Secondary packaging · Tertiary packaging ·
Blister packaging · Strip packaging · Collapsible tubes
5.1 Introduction
Packaging is one of the most important pharmaceutical parameters and may be
dened as the art, science, and technology of wrapping or protecting products for
distribution, storage, sale, and use. Wrapping material around the product serves to
contain, protect, promote, identify, and make the product marketable and keep it
clean [1].
In other words, packaging can be dened as an organized system whose function
is to prepare pharmaceutical goods for transport, sale, logistics, warehousing, and
F. Ali (*)
Department of Pharmacy, Kohat University of Science and Technology, Kohat, Pakistan
e-mail: fawadali@kust.edu.pk
I. Khan
Department of Pharmacy, University of Peshawar, Peshawar, Pakistan
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56
end use safely and effectively. The main function of packaging is to contain and
protect the enclosed product for safe transporting to sell it [2].
5.2 Properties ofPharmaceutical Packaging
The suitable packaging, labeling, and storage of all dosage forms are essential for
product stability and safe use. The following are some main properties of packaging:
– Packed content should be enclosed within the packaging material.
– Flavor of the packed content should be intact.
– It should be able to show resilience to a large range of temperature.
– It should have sufcient compulsive strength to withstand heat during steraliza-
tionand to sustain shock and external stress during shipment.
– Good mechanical strength is also a requirement for packaging to bear the pres-
sure of handling, lling, closing, and transportation.
– The shape of the packaging should be attractive and easy to use.
– If the content of the packaging material contains alkali, it should not leach to the
content.
– It should be nontoxic, inert, colorless and tastless.
– The container of the packaging material should not favor the growth of microbes.
– Closure should alsobe nontoxic and chemically stable with container contentsas
it is part of the container.
5.3 Types ofPackages
5.3.1 Primary Package
Primary packaging is the smallest unit of distribution/or use and is dened as the
packaging which is in direct contact with the formulation [3]. For example, bottles
for syrup, jar for cream, and pouch for powder, syringes, ampoule, exible bag, etc.
The basic aim of primary packaging is to hold, protect, and/or preserve the nal
product, especially against contamination.
5.3.2 Secondary Package
It holds the primary package and offers additional protection to the product during
handling. It also provides detailed information about the product [4]. For example,
carton/paper provides additional safety against mechanical and other environmental
hazards. Secondary packaging is the outermost covering. The most common
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secondary covering is carton. The main composition of the carton is cardboard. The
secondary package is not in direct contact with the drug. The secondary package
may contain associated components such as a dosing dropper and calibrated spoon.
5.3.3 Tertiary Package
Tertiary packaging is one of the three types of coveringwhich is used to protect, the
prepared pharmaceuticals during its shipping and storage.In order to easily trans-
port the bulk of secondary packages, they are often combined and grouped and
packed in tertiary packages. The main purpose of the tertiary package is the conve-
nient transport of bulk secondary packages. For example, efcient product shipping
is enabled by stretch-wrapped pallets containing several cardboard boxes (Fig.5.1).
5.4 Common Material forPharmaceutical Packaging
The selection of packaging material depends on the chemical and physical proper-
ties of pharmaceutical product, degree of protection required, compatibility with the
dosage form, size and weight of dosage form, lling method, sterilization method to
be employed and the cost of product. The most common materials used for packag-
ing of pharmaceuticals are Metals, Polymers, Glass, Plastics, Paper and Rubber.
These materials will be discussed in more detail in coming section.
5.4.1 Metal
Metal containers are often used for packaging of non-parenteral pharmaceuticals.
Metal is durable, dense, and impervious to moisture and gases. Metal is particularly
useful for packaging pressurized containers. Metal containers may be in the form of
Fig.5.1 Different types Packagingtypes of packaging
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tubes, blisters, cans and jars, etc. Common metals used in pharmaceutical pack-
aging are:
5.4.1.1 Aluminum
Aluminum is used in pharmaceutical packaging generally as layered material. It is
highly customizable. It protects the product from light, oxygen, and moisture. As a
result, it ensures longer shelf life of the product. Thickest aluminum is used in prep-
aration of tough containers like aerosol cans, and tubes for effervescent tablets.
Aluminum of intermediate thickness are used in preparing collapsible tubes for
semi-solids or roll on screw caps while thinnest one is used in exible foil that are a
component of laminated packaging material.
5.4.1.2 Tin
Tin containers are preferred for food, pharmaceuticals and any product for
which purity is critical. Itis the most chemically inert among the metals used in
pharmaceutical packaging. Nowadays, some eye preparations like eye ointments are
packaged in purely tin-made containers. The main disadvantage of tin is that it can-
not be used for extremely acidic products.
5.4.1.3 Other Metals
Iron is less common in pharmaceutical packaging; nevertheless, tin-coated steel
screw caps for jars and aerosols are used. Lead is the most economical metal.
However, due to possible toxicity, it is not common in pharmaceutical packaging.
5.4.2 Glass
Glass containers are usually the most preferred material for the packaging of phar-
maceutical products. Glass containers are usually employed as primary packages.
5.4.2.1 Composition ofGlass
Glass is a three-dimensional network that produces a network by linking silicon
atoms with four oxygen atoms in a tetrahedral fashion. Silica (60–80%) and oxides,
such as calcium oxide (5–12%), sodium oxide (12–17%), aluminum oxide (0.5–3%),
barium oxide, boric oxide, potassium oxide, and magnesium oxide, are the main
constituents of glass composition [5]. The presence of silica imparts a high melting
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