Ceutics Sop 2

Dissolution Test Apparatus
OPERATION :
 Transparent plastic Perspex Bath with cover and 1000 cc vessel
made from Corning Glass.
 Bath is fitted with 500 Watts heater.
 Electric motor provided with electronic speed regulator which

varied from 25 R.P.M TO 250 R.P.M approx.
 A stainless Steel stirring Rod fitted with Electric Motor to rotate

smooth and without any perceptible wobble in the vessel.
.
 A thermostat is provided to maintain water temperature at 37 oC
only distilled water should be filled in Bath before operation.
 The apparatus consists of a 36 mesh stainless steel basket.
 The basket is placed at the end of the stirring shaft of a variable

speed motor.
 The tablets are placed in the basket, which is then immersed in the
dissolution fluid and rotated at 100 rpm.
 The sample fluid are removed at decided intervals and fluid

volume is immediately made up by using equal to that fluid
volume removed for sampling purpose.
 Complete unit supplied with 3 core and plug to work on 220 Volt
A.C.
MONSANTO HARDNESS TESTER
OPERATION :
 The tablet to be tested is placed between the spindle anvils.

 And the pressure is applied by turning the screw knob to hold the
tablet in position.
 The reading of the indicator on the scale is adjusted to zero.
 Now the pressure is applied until the tablet breaks.
 Note the reading.
SUPPOSITORIES MOULD
OPERATION :
 The suppositories mould is made of Brass.
 These moulds are calibrated by adding the sufficient quantity of
melted base into the cavities.
 After the calibration all the components of base are melted on a
steam bath and the medicament is added.
 The melted mass is then added into the suppository moulds.
 Now allow to congeal and keep in refrigerator for thirty minutes to
get hardened.
 The top of the suppositories is then trimmed of with a spatula.
 The mould screw is loosened and the suppositories are ejected by
pushing them gently from the bottom.
WATER BATH
OPERATION :
 Ensure that sufficient amount of water is available in the water
bath
 Ensure that the instrument is properly connected to power
supply.
 Fill the bath to the level little above the falls bottom
 Switch on the supply. Put the toggle switch On.
 Set the thermostat knob to the required temperature and rising in
the temperature is indicated by glowing the RED INDICATOR
LAMP.
 When required temperature is reached, the RED INDICATOR
LAMP will go OFF.
 The bath is then allowed to work .
 After completion of heating process , reduce the temperature to
zero , by rotating the temperature setting knob to zero position.
 Switch off the power supply and allow the bath to cool to the
desired temperature before the control knob is turned
backwards . This is to eliminate unnecessary strain on the
thermostat..CLEANING
 The calibration done by external agency

SINGLE PUNCH TABLET MACHINE
OPERATION :
Stage 1:
 Top punch is withdrawn from the die by the upper cam.

 Bottom punch is low in the die so powder falls in through the hole
and fills the die.
 The granules are fed from the hopper into the feeding shoe ,which
guides the material into the die cavity.
Stage 2:
 Bottom punch moves up to adjust the powder weight-it raises and

expels some powder
Stage 3:
 Top punch is driven into the die by upper cam.

 Bottom punch is raised by lower cam.
 Both punch heads pass between heavy rollers to compress the

powder
Stage 4:
 Top punch is withdraw by the upper cam.
 Lower punch is pushed up and expels the tablet.
Tablet is removed from the die surface by surface plate
FRIABILITY TEST APPRATUS DOUBLE DRUM
OPERATION :
 Used for tablets to determine the determine the durability at the
time of production.
 A transparent plastic Perspex drum 300 mm Diameter x 35 mm

deep with cover approx.
 Also shaped radial fixed blades which the tablets along with it up
to the central height and let them off while drum is rotation, thus
the tablet rub against each other without any hard impact.
 The drum rotates at a fix speed of 30 R.P.M by geared motor.
 Electric timer in between 1 to 5 R. P.M/ Digital revolution

counter(preset counter) The motor unit is covered in steel cabinet
controls the rotation period and shaft extended on one side which
the plastic drum rotate.
 Tablets are weighed before and after the test and the difference is
weight for a particular time prior indication the rate of abrasion.
 Compressed tablet should not lose more than 1% of their weight.
 This friabilator evaluates the ability of the tablet to withstand

abrasion in packing, handling and shipping.
O
HOT PLATE – STIRRER
OPERATION :
 Ensure that the Hot plate has been electrically tested.
 Examine the electrical cable.
 Turn on the stirrer and hot plate.
 Place beaker with the solution on the hot plate.
 If the temperature is over 45ºC be careful, touching the apparatus
surface may burn you.
a) Wear Heat Proof Gloves as required.
b) Place a “HOT SURFACE” sign at the hot plate
when in use.
c) Do not use Mercury thermometer – (use only
alcohol thermometers).
 When completed, turn off.
 Remove the “Hot Surface” Sign when the hot plate has cooled
down.
HAND OPERATED CAPSULE FILLING MACHINE
OPERATION :
 For filling, empty capsules are placed in the machine.

 A clamp provided in the lower plate holds the capsule bodies and
removes and replaces the caps mechanically.
 The lower plate can hold three sizes of the capsules in the
perforations.
 In the initial step separation of cap from the body.
 Filling the body of the capsule with active pharmaceutical

ingredient and additives.
 Rejoining the cap and the body.
 Imperfect capsules are sorted out by visual checking method.
SIMPLE DISTILLATION OPERATION :
 Select a distillation flask and fix it to the stand.

 Take a double holed cork and fix it to the stand.
 Fix thermometer in one hole of the cork.
 Fix the condenser in the other hole of the cork.
 Arrange water line to the condenser.
 Prepare different compositions of mixtures of acetic acid and water
 Place the first mixture (40ml acetic acid + 10 ml water) in the distillation
flask.
 Heat the distillation flask and distill until a constant temperature is reached
i.e. no further increase in temperature.
 At this movement ,note the temperature of the thermometer which is
boiling point of mixture of acetic acid + water .
 Collect about 5ml of condensate in a small beaker and simultaneously
measure 1gm of distillate using a weighing bottle.
 Transfer the 1 gm of distillate to a conical flask and titrate with 1 N
sodium hydroxide using phenolphthalein as indicator.
 Determine the weight of acetic acid present in 1gm sample.
 At the same time the remaining weight from the 1gm sample will give us
the weight of water present in the mixture.
 Determine mole fraction of acetic acid and water present in the distillate.
 Similarly determine the mole percentage of acetic acid and water in the
contents of the distillation flask.
 Repeat the entire experiment for the remaining three samples and
determine different compositions of acetic acid and water in liquid as well
as water phase.
 Construct boiling point diagram by plotting percentage composition of
acetic acid and water on x-axis and the corresponding boiling points on y-
axis.
COATING PAN
OPERATION :
 Standard coating pan systems consist of circular metal pan.
 This pan is mounted on stand angularly.
 It is rotated in horizontal axis by a motor.
 Coating is normally applied by spray pan method.
 And the tablets are fed into the pan through the circular opening.
 It is connected with inlet for supply of warm air.
 There is provision of outlet for exhaust.
DISINTEGRATION TEST APPARATUS
OPERATION :
 Used for determination of disintegration of time of Tablets.
 The test equipment consists of 1 liter Beaker.

 Tablet can be tested simultaneously through motorized shaft moves
up and down direction of 28 to 32 R.P.M approx.
 Carrying a rigid basket rack assembly. On the upper end of the

shaft is fitted a horizontal strip to support cylindrical standard size
glass tubes with stainless steel wire gauge bottom.
 Cylindrical basket moves up and down with standard perforated

made of acrylic sheet inside in one liter glass beaker of distilled
water.
 Unit having hot plate rating 65 watts fixed on the top for BEAKER
 Temperature can be maintained by thermostat in between 35 C to

37o C.
 The tablets are kept immersed in the liquid within the tubes by the
cylindrical guided disc.
 One tablet is placed in each of the six tubes of the basket and disc
is added to each tube.
 The tablet pass the test if all six have disintegration in not more
than 15 minutes.
 Disintegration time for coated and enteric coated tablets should not
exceed 1 and 3 hours respectively.
DOUBLE CONE BLENDER

OPERATION :
 Check and make sure that Double cone blender has been
autoclaved.
 Adjust the angle of the blender with the help of a moving wheel
to a required position for convenience in loading the materials.
 Load the materials from the container to the blender .
 After loading the materials, close the lid of the blender.
 Put the safety pin on the lid and fit it properly within its groove.
Lock the blender lid by moving the wheel in clockwise
direction.
 Before starting the operation, ensure that the lid and the safety
pin lock has been assembled properly.
 Put the safety guard before commencement of the operation.
 Switch on the equipment and note down the starting time.
 To unload the material, Remove the safety guard.

Ceutics Sop 2

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What are the different types of equipment described in the document and what are they used for?

What are the different types of equipment described in the document and what are they used for?

What are the steps involved in coating tablets using a coating pan?

What are the steps involved in coating tablets using a coating pan?

Dissolution Test Apparatus

 Bath is fitted with 500 Watts heater.

 Electric motor provided with electronic speed regulator which

 A stainless Steel stirring Rod fitted with Electric Motor to rotate

 The apparatus consists of a 36 mesh stainless steel basket.

 The basket is placed at the end of the stirring shaft of a variable

 The sample fluid are removed at decided intervals and fluid

 The tablet to be tested is placed between the spindle anvils.

 The calibration done by external agency

 Top punch is withdrawn from the die by the upper cam.

 Bottom punch moves up to adjust the powder weight-it raises and

 Top punch is driven into the die by upper cam.

 Both punch heads pass between heavy rollers to compress the

 Top punch is withdraw by the upper cam.

 Lower punch is pushed up and expels the tablet.

Tablet is removed from the die surface by surface plate

FRIABILITY TEST APPRATUS DOUBLE DRUM

 A transparent plastic Perspex drum 300 mm Diameter x 35 mm

 The drum rotates at a fix speed of 30 R.P.M by geared motor.

 Electric timer in between 1 to 5 R. P.M/ Digital revolution

 Compressed tablet should not lose more than 1% of their weight.

 This friabilator evaluates the ability of the tablet to withstand

HAND OPERATED CAPSULE FILLING MACHINE

 For filling, empty capsules are placed in the machine.

 In the initial step separation of cap from the body.

 Filling the body of the capsule with active pharmaceutical

 Rejoining the cap and the body.

 Imperfect capsules are sorted out by visual checking method.

SIMPLE DISTILLATION OPERATION :

 Select a distillation flask and fix it to the stand.

DISINTEGRATION TEST APPARATUS

 The test equipment consists of 1 liter Beaker.

 Carrying a rigid basket rack assembly. On the upper end of the

 Cylindrical basket moves up and down with standard perforated

 Temperature can be maintained by thermostat in between 35 C to

DOUBLE CONE BLENDER

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