Blister Packaging Liding

1.0 Executive Summary

Planned maintenance has to begin with a plan in mind. Developing
preventive maintenance tasks or procedures for your plant or facility
without a solid plan will result in inconsistent and unreliable procedures.
Because it is important to document the development process, build-in
consistency, and develop a good understanding of expected results, the
Equipment Maintenance Plan is a powerful tool.

2.0

Introduction

Maintenance is a routine and recurring activity of keeping a particular

machine or facility at its normal operating condition so that it can deliver
its expected performance or service without causing any loose of time on
account of accidental damage or breakdown.
Once

equipment

is

designed,

fabricated

and

installed,

the

operational availability of the same is looked after by the maintenance

requirement. The idea of maintenance is very old and was introduced
along with inception of the machine. In the early days, a machine was
used as long as it worked. When it stopped working, it was either
repaired/serviced or discarded.
The

high

cost

sophisticated

machines

need

to

be

properly

maintained/serviced during their entire life cycle for maximizing their

availability. The development of mechanization and automation of
production systems and associated equipment, with the accompanying
development of ancillary services and safety requirements, has made it
mandatory for engineers to think about proper maintenance of equipment.
Maintenance is a function to keep the equipment/machine condition
by

replacing or repairing some of the components of the machine. The

maintenance concept is an outline plan of how the maintenance function

will be performed. Based on the feedback obtained from the users and the
history of the equipment, detailed procedures are drawn to concretize the
maintenance concept. The procedures developed thus are collectively

called the maintenance plan. The development of such a maintenance

plan is one of the most important requirements of the maintenance
program that requires interaction between the user and the manufacturer.
With this information, the manufacturer will be in position to rearrange the
design as per users maintenance requirements.

2.1

Objective

The objectives of maintenance should be formulated within the framework

of the overall organizational setup so that finally the goals of the
organization are accomplished. For this, the maintenance division needs to
ensure that:
(a) The machinery and/or facilities are always in an optimum working
condition at the lowest possible cost
(b) The time schedule of delivering to the customers is not affected
because of non-availability of machinery/service in working condition
(c) The performance of the machinery /facility is dependable and reliable.
(d) The performance of the machinery /facility is kept to minimum to the
event of the breakdown.
(e) The maintenance cost is properly monitored to control overhead costs.
(f) The life of equipment is prolonged while maintaining the acceptable
level of performance to avoid unnecessary replacements.
Maintenance is also related with profitability through equipment output
and its running cost. Maintenance work enhances the equipment
performance level and its availability in optimum working condition but
adds to its running cost.

2.2

Scope

2.3

Machice Details

2.3.1 Blister Packaging

Blister

pack is

plastic packaging used

term
for

for
small

several

types

of

pre-formed

consumer

goods,

foods,

and

for

pharmaceuticals. The primary component of a blister pack is a cavity or

pocket made from a formable web, usually a thermoformed plastic. This
usually has a backing of paperboard or a lidding seal of aluminum foil or
plastic. A blister that folds onto itself is often called a clamshell. Blister
packs are useful for protecting products against external factors, such
as humidity and contamination for

extended

periods

of

time.Opaque blisters also protect light-sensitive products against UV rays.

Blister packaging is an inexpensive option for creating packages that are

durable, transparent, and tamper proof. These clear plastic blister packs
are used in conjunction with a cardboard blister card to keep the product
in full view for the customer to examine.
The blister packaging is attached to the blister card through a heat-sealing
process that allows the product to be displayed in a wide variety of
methods. While this heat sealing process can be done with highly
automated equipment, the use of blister packs is somewhat limited to light
weight items. For heavier items, one should consider using plastic
clamshells.
3.0

Machine Details

3.1

Blister Packaging Components

The four basic components of pharmaceutical blister packages are the

forming film, the liding material, the heat seal coating, and the printing
ink. The most common blister package in the Unoited States is made of a
foil, film, paper or multimaterial backing that is adhered to a sheet of
thermoformed plastic bubbles. Forming films account for approximately
80-85% of the blister package, and liding material make up 15-20% of the
total weight of the package. Because the forming film and the liding
material form an an integrated package, they must match precisely.

3.1.1 Forming Film

The forming film is the packaging component that receives the product in
deepdrawn pockets.One key to package success is selecting the right
plastic film for the blisters in terms of its property type, grade,and
thickness.Consideration must be given to the height and weight of the
product, sharp or pointed edges of the final package,and the impact
resistance, aging, migration, and cost of the film. The plastic also must be
compatible with the product.Factors influencing package production and
speed of assembly must be taken into account, including heatsealing
properties and the ease of cutting and trimming formed blisters.

4.0

Blister Packaging Machinery and Assembly

Modern thermoformfillseal machines can operate at speeds <800

packages/min. Today,much of the emphasis in improving production is
placed on applying microprocessor controls that electronically connect the
filling and forming equipment with other downstream machinery for
cartoning and wrapping. These controls also feed tablets or liquids into the
unit-dose blisters,ensuring that an exact volume is put into each.Modern
machinery also uses integrated vision systems to help ensure the accuracy

of the fill and the integrity of the product in the blister.These machines
have become quite versatile and can readily accommodate several types
of lidstocks and basestocks, allowing the manufacturer to obtain better
compatibility between the medicine and its packaging material as well as
better patient compliance. Blister packaging offers many advantages to
the industry and to the public, and the machinery will continue to support
this proven form of pharmaceutical packaging. Improvements in the form,
materials,and machinery for blister packaging will continue to increase the
applicability of this method for containing and distributing pharmaceutical
products.

4.1

General Assembly

The sequence involves heating the plastic,thermoforming it into blister

cavities,loading the blister with the product,placing lidding material over
the blister,and heat-sealing the package.This can be a simple manual
process,or it can be partially or fully automated.Although purchasing
empty,preformed blisters and lidding material and then filling the product
in a separate step is possible, this is rarely done. Instead, the package is
created and filled on the same machine.
4.2

Detailed Assembly

Blister packaging machines typically operate with intermittent motion.The

seal is made during the dwell time required for thermoforming.The

essential parts and functions of an intermittently operating packaging

machine include the following

4.2.1 The unwinding station

The unwinding station supplies the forming films and the lidding material
at a rate corresponding to the speed of the packaging machine

4.2.2 The Heating station

The heating station raises the temperature of the plastic forming films to a
level suitable for deep drawing. Forming films containing the polyvinyl
chloride (PVC) support material are heated to 120140 8C. Polypropylene
(PP) forming films are heated to 140150 8C. Forming films containing
aluminum are not heated before the forming.

4.2.3 The Forming station

The forming station forms the plastic blister cavities via compressed air or
die plates.Films containing aluminum are formed with mechanical forming
tools only.

4.2.4 The Cooling station

The cooling station cools PP films after the forming process. Laminates
containing PVC or aluminum do not need to be cooled.

4.2.5 The Feeding machine (Part C)

The loading area fills the blister cavities with product.The feeding machine
can be linked, or the product to be packaged can simply be swept into the
blisters.

4.2.6 The Sealing station (Part D)

The sealing station heatseals the lidding material to the forming film that
contains the product All heat-sealing methods mate the blister and lid
under constant pressure for a specified time,during which heat is supplied.
The mating surfaces fuse and bond,setting almost instantaneously when
heat input stops. Depending on the type of machine,the sealing
temperature typically ranges between 140 and 340 8C.

4.2.7 The Cooling station (Part D)

The cooling station is necessary with all forming films.PP forming films
must be cooled longer than other types of film.

4.2.8 Labeling through packaging

types of film. Labeling through packaging. Packages are labeled, notched,
and then marked with a batch number at the coding station. The
perforating device makes a cross-shaped perforation along the sealing
seams.At the punching station, the packages are then
separated into sheets that typically contain from 10 to 20 individual
blisters. The vision system checks the filled packages for defects. Finally, a
multipacking machine packs the individual packages into bigger cartons.

5.0

Maintenance

5.1

Breakdown Maintenance

The basic concept of breakdown maintenance is not to do anything as long

as everything is going on well. Hence, no maintenance or repair work is
done until a component or equipment fails or it cannot perform its normal
performance. In other words, the maintenance work is called upon when
the machine is out of order, and repairs are required to bring back the
equipment to its original working condition.
If the system is alone followed, it will lead to poor operational
availability of the equipment, as spare parts may not be readily available.
Though it appears to be economical proposition, work would greatly suffer
if the machine is not restored to operational condition at the earliest. In
this type of maintenance, during the repair time, no proper care is taken to
know the real cause of the breakdown, which in turn may lead to frequent
failures of the same kind.

5.2

Preventive Maintenance

5.3

Predective Maintenance