Standard Operating Procedures or SOPs

•A document which describes:

“the regularly recurring operations

relevant to the quality of the investigation.”

Purpose

To carry

out the operati

ons correctly and always in the same

manner.

Where should it be available?

A SOP should be available at the place where the work is done.

Types of SOP’s for manufacturing apparatus

SOP’s

Operating

Cleaning

Maintenance

Training

Operational & cleaning SOP’s for FLUIDIZED BED DRYER

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.

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 switchUnlock & 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

Simply turn on the main supply.

Turn on cabinet blower and light.

Give it some time to stabilize.

OPERATIONAL & CLEANING OF SOPs for LAMINAR FLOW HOOD

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 testing?

Process that tests how well a product retains its properties

over the lifetime of the product.”

Stability chamber

Operational SOP

1

•Check the correct positioning of the chamber.

2

•If the chamber has a control panel/ system, this can be checked too:•Butt

ons, switches, alarm, door etc.

3

•Perform a thermal/humidity mapping of the chamber for the established set point.

4

•At this point the mapping is performed with empty chamber.

Assure that temperature and

humidity are evenly distributed

inside the chamber.

Assure that the established acceptance

criteria are met at any point of the chamber.

Mappings: purpose

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

Clean the whole

machine with the help of dry duster.

Then clean with cloth having

detergent (2%v/v) and with dry duster again.

Disconnect the

electrical supply.

Open the nozzle by rotating

clockwise and clean its parts.

Clean nozzle parts by means of stirrer with which lint free

cloth is attached.

Dry with dry lint

free duster.

Operational & Cleaning SOP’s for Tablet Compression Machine

Tablet Compression Machine

Operation

Hopper is positioned by fixing the spring to the

support.

Switch on the button.

Then put the granules in

hopper.

Tablet formation will be started.

Operate it accordingly.

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.

Switch on the mains of the following:

Coating pan & Hot air

unit.

Ensure the working and effectiveness of hot air unit.

Arrange the position of hot air blowers unit

and coating machine.

Load tablets from container

into the coating pan.

A Spray of coating is done with the help of

spraying gun until smooth coating

achieved.

After completion, switch off the hot air unit first, then off the

Tablet coating machine.

Precautions:

•Accurately arrange the position of coating machine with hot air unit.•Spray should be done carefully.

CleaningIs done.

Remove the dry powder from pan.

Pour about 10 liters of hot water in pan and

allow rotating for about 10 minutes.

Then drain out in a container and clean inside of pan with

nylon brush.

Then wash with water having detergent. Rinse with warm

water

Then dry with lint free duster.

Switch off the power supply.

Thanks!!!

Any question???