Standard

“the regularly Operating

recurring operations • A document Procedures or
relevant to the quality which SOPs
of the investigation.” describes:
 To carry out the
operations correctly
and always in the same Purpose
manner.
 A SOP should
be available at
the place where
the work is
done.
Where should it
be available?
Types of SOP’s for manufacturing
apparatus

Operating

Training SOP’s Cleaning

Maintenance
Operational & cleaning SOP’s for
FLUIDIZED BED DRYER
 “A device which is used to
produce dry particulate
products by employing the
principle of fluidization is
called fluidized bed dryer.”

Fluidized Bed Dryer

Fluidized Bed Dryer.
Operational & cleaning SOP’s for
Fluidized Bed Dryer

Rotate the lever

anticlockwise to separate
the bowl from upper part.

Load the bowl with

material to be dried.
Position the bowl.

Lift the bottom of the FBD

by moving the jack handle
clockwise and seal the
trolley to the chamber.
Adjust time and
temperature according to
requirement.

A string joined with upper

part of filter bag is pulled
to de-dust the filter bags.
Lever, present
on the upper
side of the
apparatus is
pulled so that
air comes out.
After drying is
complete switch off
the main switch

Unlock & withdraw

the bowl
Cleaning:

Clean outside of the dryer

with wet duster and then
with clean dry lint free
duster.

Wash chamber container

first with tap water and then
with detergent (2% v/v).
Then rinse it with
purified water and
dry it.

After cleaning cover

the apparatus.
Operational & cleaning SOP’s for
Laminar flow hood
Laminar Flow Hood

“A laboratory
device which flows
filtered air onto a
specially enclosed
work surface.”
Laminar Flow Hood
OPERATIONAL & CLEANING OF
SOPs for LAMINAR FLOW HOOD

Simply turn on the main

supply.

Turn on cabinet blower and

light.

Give it some time to

stabilize.
Cleaning:

Clean the inside,

cabinets and protective
screen with suitable
disinfectant
Precaution:

It is recommended to
run for laminar flow
hood for 15- 20
minutes prior to use.
Operational & cleaning SOP’s
for Stability Test Chamber
Stability testing chamber

What is stability Process that tests how

testing? well a product retains
its properties over the
lifetime of the
product.”
Stability chamber
• If the chamber has a control panel/ system,
this can be checked too:
2
• Buttons, switches, alarm, door etc.
• Check the correct positioning of the 1
chamber.
Operational SOP
• At this point the mapping is
performed with empty
4
chamber.
• Perform a thermal/humidity
mapping of the chamber for the
3
established set point.
 Assure that Assure that the
temperature and established
humidity are acceptance
Mappings:
evenly criteria are
purpose
distributed met at any
inside the point of the
chamber. chamber.
Precaution

Carefully open the

glass door of
chamber.
 Cleaning

•Clean the entire apparatus with

mop wetted in clean water.
•Then dry with lint free mop.
Operational & Cleaning SOP
for Ointment Filling Machine
Ointment Filling Machine
 Operational & Cleaning SOP for
Ointment Filling Machine

Clean the hopper to remove

any dust.

Switch on the button.

Screw is adjusted by pouring material other
than the desired product in order to set the
desired quantity to be filled in bottle.

After adjusting desired product is poured into the

hopper
Place the ointment bottle under the nozzle.

When the containers get filled it automatically

stops.

Place the next bottle under the nozzle and

filling of next container will automatically start.
Precaution

•The filling machine must be

assured to fill required
volume.
•Use only clean bottles and
caps.
 Cleaning

Cleanclean
Then the whole
with machine
cloth withdetergent
having the help (2%v/v)
of dry duster.
and
Disconnect the electrical supply.
with dry duster again.
 Open
Clean
Drythe nozzle
nozzle
withparts by
by rotating
dry lint means ofclockwise
free duster. and
stirrer with
which lint clean its parts.
free cloth is attached.
Operational & Cleaning SOP’s for Tablet
Compression Machine
Tablet Compression Machine
Operation

Hopper is positioned
by fixing the spring to
the support.
Switch Then put the
on the granules in
hopper.
button.
 Operate it accordingly.

Tablet formation will

be started.

Dies can be changed according

to required shape of tablets.
Precaution

Grease is applied to avoid

erosion to dyes.
Cleaning
Turn off
the
electric
supply.

Remove the parts and wash

with hot water having
detergent and then rinse
with cold clean water.
 Dry
them...
Operational & cleaning SOP’s for
Tablet Coating Pan
Operation

Fix the hot air

blower unit with
coating pan.

Coating
Switch on the mains
of the following: pan & Hot
air unit.
 Ensure the
working and
effectiveness
of hot air unit.

Arrange the Load tablets

position of from
hot air container into
blowers unit the coating
and coating pan.
machine.
 A Spray of coating After completion,
is done with the help switch off the hot
of spraying gun air unit first, then
until smooth coating off the Tablet
achieved. coating machine.
Precautions:

•Accurately arrange the position of

coating machine with hot air unit.
•Spray should be done carefully.
 Remove the
dry powder
from pan.
Pour about 10 liters
Switch off the of hot water in pan
power supply. and allow rotating
for about 10 minutes.

Cleaning
Is done.
Then drain out in a
Then dry with lint container and clean
free duster. inside of pan with
nylon brush.

Then wash with

water having
detergent. Rinse
with warm water
Thanks!!!
Any question???