Pharmaceutical Equipment

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PHARMACEUTICAL

EQUIPMENT

GRANULATION
To impart good flow properties to the
material,
To increase the apparent density of the
powders,
To change the particle size
distribution,
Uniform dispersion of active
ingredient.

WET GRANULATORS

DRY GRANULATORS

SHEAR GRANULATORS

TABLET MACHINE

HIGH SPEED
MIXER/GRANULATORS

ROLLER COMPACTORS

FLUIDIZED-BED
GRANULATORS

SINGLE equipment

save labor cost

automation

Time

Transfer losses

Hopper
for holding and feeding granulation to be compressed

Dies
that define the size and shape of the tablet

Punches
for compressing the granulation within the dies

Cam tracks
for guiding the movement of the punches

Feeding mechanisms
for moving granulation from the hopper into the dies

TABLET COATING EQUIPMENT


1. Standard coating pan
Pellegrini pan system
Immersion sword system
Immersion tube system

2. Perforated pan system


Accela-Cota
Hi-coater system
Glatt coater system
Driacoater system
3. Fluidized bed coater

TABLET COATING EQUIPMENT


Standard pans
Perforated pan system
Fluid pan coater

PHARMACEUTICAL
DRYERS

SPRAY DRYERS
Can handle only liquid as solution, Slurries,
dispersed as fine droplets into a moving
stream of hot gas.

Tablet defects

Problem in tablets are either related to


imperfections in any one or more of the
following factors:

Tableting
Excipient Machine
Process

TABLET DEFECTS
PROCESS
CAPPING
LAMINATION
CRACKING

TABLET DEFECTS
EXCIPIENT
CHIPPING

STICKING/ FILMING
PICKING

BINDING
MOTTLING

TABLET DEFECTS
MACHINE
DOUBLE IMPRESSION

PEELING

ORANGE
PEEL EFFECT

MOTTLING

BRIDGING

TABLET
EROSION

COATING PROBLEMS

PICKING

TABLET PACKAGING
PROTECTION

stability test conditions

COMPATIBILITY

REGULATORY

COMMERCIAL
image
market
requirements/trends
dosing/patient
compliance
security/tamper
evidence
manufacturing
economics - COG

TABLET PACKAGING

BLISTER PACKS

STRIP PACKAGE
BOTTLES

PACKAGING: BLISTER BASE


Material should preferably be opaque white unless clear is

a specific market requirement (e.g. US, Japan).


Meet shelf-life requirements and also prevents tampering.
PVC, PCTFE, AND PP

THERMOFORM
BLISTER
COLD FORM
BLISTER

plastic base web


blister formed with aid of heating
low to high barrier
blister formed mechanically (no heat)
high barrier

PACKAGING: BLISTER BASE


THERMOFORM BLISTER

COLD FORM BLISTER

PACKAGING: BLISTER BASE


TROPICALISED
BLISTER
thermoform blister plus
cold form tray
once tray opened, in use
life determined by
primary thermoform
blister
high barrier before use

PACKAGING: STRIP PACK


Is formed by feeding 2 webs of a
heat sealable flexible film through a
heating crimping roller. The product
is dropped into the pocket formed
before forming the final set of seals.
Cellophane, polyester, polyethylene,
polypropylene and PVC.
STRIP PACK are produced at lower
speeds and occupy greater volume
than blister pack.

PACKAGING: BOTTLES
GLASS

type III (solids)

type I (parenterals)

PLASTIC

low density polyethylene LDPE


high density polyethylene HDPE
polypropylene PP
polyester PET, PETG
Cyclo-olefin copolymer (COC)

EVALUATION OF PRIMARY PACKAGING MATERIALS


LEAKAGE TEST
HYDROLYTIC RESISTANCE
COLLAPSIBILITY
RESIDUE ON IGNITION
BUFFERING CAPACITY
LIGHT TRANSMISSION
WATER VAPOR PERMEATION
HEAVY METALS AND NON-VOLATILE

RESIDUES

EVALUATION OF PRIMARY
PACKAGING MATERIALS
1.Leak testing is the measurement of the amount of
media leaking through material over time.
2.Residue on Ignition Test is designed to measure
the weight of the residual substance when sulfuric
acid is added to the sample and then ignited.
3.Water vapor transmission is a measure of how
much water vapor will pass through a material per
unit area per unit time.

EVALUATION OF TABLET
GENERAL APPEARANCE
Size and Shape
Organoleptic Properties

DRUG CONTENT AND


RELEASE

Content Uniformity
Weight Variation test
Tablet Thickness
Disintegration test
Dissolution test
(Apparatus 1 and 2)

MECHANICAL STRENGTH

OF TABLET

Friability
Tablet Hardness

EVALUATION OF TABLET
OFFICIAL TESTS

Weight variation
Disintegration
Dissolution
Drug content.

NON-OFFICIAL TESTS
Hardness
Friability

The End

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