SOP FOR OPERATION AND CLEANING OF SQUARE CONE BLENDER
OBJECTIVE: To lay down the procedure for Operation, cleaning, setting, and in process check of Square cone blender.
SCOPE: This standard procedure is applicable to carry out Operation, cleaning, setting, and in process check of square cone blender.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during Operation, cleaning, setting, and in process check of square cone blender.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the equipment if any break down occurs during the operation.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records. Check and ensure blender and the area are clean before start the blending activity.
Officer/Supervisor or designee of IPQA is responsible for the line clearance and verification of the related documents along with ensuring the compliance of SOP.
User wise responsibility:
Operator:
To start and end of operation.
To review the process parameter against the operation parameter mentioned in respective product BMR.
To perform the cleaning of respective equipment as per procedure defines in the SOP.
To rectify any troubleshooting command.
Supervisor:
To set the validate parameter of operation as mentioned in respective product BMR.
To review the process parameter against the operation parameter mentioned in respective product BMR.
To ensure the cleanness to respective equipment as per SOP.
To take the line clearance before start of the activity/ Operation.
IPQA personal:
To review the process parameter against the operation parameter mentioned in respective product BMR.
To ensure the cleanness to respective equipment as per SOP.
To ensure the respective operation will carried out with validate parameter as mentioned in respective product BMR.
To give line clearance before start of the activity/ Operation.
Engineering personal:
To perform the preventive maintenance as per procedure described in respective SOP.
To ensure the respective operation will carried out with validate parameter as mentioned in respective product BMR.
Administration:
To rectify any troubleshooting command.
To calibrated of Date, time and RPM.
To change the user password.
ACCOUNTABILITY:
Head Production: To implementation of this SOP.
Head of the Quality Assurance: Head QA shall authorized the SOP and ensure its proper implementation to ensure that manufacturing process is carried out in a manner that the product meets all specified quality attributes
PROCEDURE:
Definition: The Square cone blender is a simple unit used for dry blending and lubrication of powder and granules. It uses the principle of tumbling of powder in a partial void to cause mixing. Motion is achieved by mean of a motor coupled to a gear box and final speed reduction through coupling driven assembly. The entire drive assembly and the bearing housing are enclosed with S.S. cover.
Equipment Description: The machine basically consists of
Blender frame with motor and electrical assembly
Drive unit
Pre start up:
Check and ensure blender and the area are clean before start the blending activity.
Ensure “Cleaned” label on the equipment.
Replace “Cleaned” label with “Under process” label.
Check and make sure that Square Cone Blender has been cleaned.
Visually check the equipment and area for its cleanliness.
Do not touch the moving part of the machine when the machine is in operation mode.
Do not operate the machine without a safety guard.
Take the line clearance from IPQA person and record in Batch Manufacturing Record (BMR).
Operation:
The flow diagram below represents the steps in routine operation of the
- Machine Preparation
- Charge the material to be blended
- Set the timer for blending
- Machine Operation
- Pres the start button
- Machine Stop automatically after blending
- Unload the blending materials
Auto Process:
Before starting the operation, ensure that the lid and the safety pin lock have been assembled properly.
Power on the Blender machine and LOGIN at supervisor levels by Password.
Auto switch on the main screen which is used to auto process Data.
Press the RECIPE option to set different Parameters:
Set the RPM, Blending time
Set the code, product code, Blending, Running time etc.
The screen shows Auto start CONFIRM by switching this we can Safety Confirm and Run the Machine after confirm.
Manual Process :
Set the RPM, Blending time and start the machine.
To unload the material, ensure that the equipment is put off. Remove the safety guard.
Adjust the position of the blender at the required angle for convenience in unloading the materials.
Unlock the safety pin and remove the lid from the blender.
Unload the blended materials. After completion of operation, transfer blend to respective quarantine area.
Replace “Under process” label with “To be cleaned” label.
Record the equipment uses details in activity log book.
Note:
Use latex gloves during loading and unloading of materials.
Before loading of the materials, ensure that the inner and outer surface of the drum blender is cleaned as per the standard procedure respectively.
During blending operation attach status label to the drum blender specifying the name of the product, Batch no., Mfg Date, and Exp. Date along with signature of production officer.
The following procedure is to be followed for charging the material for blending into the Square cone
Ensure that the Square cone Blender is thoroughly clean and ready to receive the material for blending.
Bring the Mixer in the upright position (the butterfly valve is at the bottom) manually, by pressing the inching switched.
Rotate the blender and bring it in upright position (the butterfly valve is at the bottom)
By the help of SS trolley Bring the raw material which were filled in polybag and place it blending area. Area operator Climbs to the ladder provided with the equipment and will be load the all raw materials polybags into the blender bin.
Open the upper lid slowly by losing Nut & bolt. Now the powder starts flowing into the blender.
When powder is fully charged into the blender close the upper lid.
Lock the upper lid by tightness of nut& bolt.
Rotate the blender and bring the mixer in upright position (the butterfly valve is at the top).
Close the butterfly valve slowly through tightness of pin provided below, which is attached to the valve.
Do not charge the material quantity more than the rated capacity of the blender.
The following procedure is involved in discharging the blended material.
After the blending is over, make the Square cone Blender in upright position (the discharge port is at the bottom) manually, by pressing the inching switched.
The area operator Unclamp the upper lid by losing nut & bolt provided above of Lid.
Bring an empty clean bin below the discharge port.
Open the butterfly valve slowly through Pin handle, which is attached to the butterfly valve. Now the blended powder starts flowing into the bin through gravity pressure.
If more than one bin is required to collect the total blend, close the butterfly valve fully and remove the filled bin then placed the new one container.
After the Square cone Blender is totally emptied out, close the butterfly valve. The Square cone Blender is ready for the further upcoming activity.
If there is a product change, the Square cone Blender is to be cleaned thoroughly as per the procedure describes in point no. 5.5
The following procedure is involved in cleaning the Square cone Blender.
Cleaning at the time of batch changeover/same product of ascending potency:(Type A cleaning)
Remove loosely stacked powder from the machine using vacuum cleaner and lint free mop.
Dismantle the machine in the following sequence and keep them on pallet-
- Back lid
- Charging lid
- Clean the dismantled parts by using vacuum cleaner and dry lint free mop.
- Clean the machine and dismantled parts with a dry lint free mop.
- Clean the room thoroughly.
- Assemble the cleaned dismantled parts.
After cleaning affix, the “CLEANED” label on the equipment.
Record the cleaning details in the Usage logbook.
Cleaning at the time of product changeover/same product of descending potency/preventive maintenance of the contact parts( Type B Cleaning)
Make the Square cone Blender (in empty condition) in upright position manually by pressing the inching switched.
Clean the machine with Purified water.
Fill approximately 100 litter’s purified water in to blender, close valve and run blender for 10 minutes.
- Remove water from blender, collect in container and drain.
- Again, Wash the blender properly with purified water.
- Clean the charging port with purified water.
- Clean all above parts in purified water using lint free cloth.
Rinse the machine and the dismantled parts with purified water and intimate to IPQA to collect the rinse water sample.
IPQA will send the rinse water sample to Q.C. department to confirm the absence of previous product.
Sanitize all cleaned parts with 70% IPA and assemble.
Assemble the machine. Cover the hopper & delivery chute with polythene bags.
Affix “CLEANED” status label and record the cleaning details in activity log book.
MMI Operation& setting of machine parameters
Home Screen
Switch on the main supply; confirm MCB & UPS is in ON state.
When we power up MMI screen this shows display as below (Figure no. 01). So first we have to login at different level by password.
The screen is displayed after the HMI (Human Machine Interface) boots up.
During different-different levels wise operation kindly fill the user code as mentioned below.
Operator level login ID is denoted with “O”.
Supervisor/ Manger level login ID is denoted with “S”.
Engineering personal/ Maintenance personal level login ID is denoted with “M”.
Administration level login ID is denoted with “Solace”.
User click the login now button.
Now User enters the user I.D. and password then
After that new HMI screen will open (Figure no. 02) we can see different switches which used for different functions.
Manual switches are used to manual mode from menu screen.
I/O Status switched is used for shown digital input/ Output status.
In screen we see ACK switched to acknowledge of all alarms.
Now on the main screen we see auto switched which is used to Auto process data.
On the main screen we can see change user level. This switched is used to change user level.
When we did the click on this switched then new screen will be open (Figure No. 03).
In this screen we cans see login switched to login at different level.
Logout switched is used to log out.
Change password switched is used to change password.
On main home screen (Figure No. 01) we can see alarm switch by pressing this we can see alarm screen
In above screen display we see ACK switched to acknowledge all alarms.
On main home screen we can see I/O status switch by pressing this we can see No of inputs and outputs used.
On main home screen (Figure No. 02) we can see calibration switch by pressing calibration switch we can see new screen.
Now on main home screen we have two different switches for manual mode and auto mode.
By pressing manual mode, we can see and set the different set parameter.
By pressing Auto mode, we can see and set the different set parameter as given below in figure no.08.
In the screen to activation of safety feature kindly press OK. If someone disturbed the safety guard, then the process will be discontinued.
To continue this process, press OK command.
After feed the validated values of above describe parameter, we can start the operation by confirmed Ok command. This one is safety confirmation. After confirmation of or pressing the command of Run (as define in figure no. 09) the process will start.
Auto Process:
Before starting the operation, ensure that the lid and the safety pin lock has been assembled properly.
Power on the Blender machine and LOGIN at supervisor levels by Password.
Auto switch on the main screen which is used to auto process Data.
Press the RECIPE option to set different Parameters:
Set the RPM, Blending time
Set the code, product code, Blending, Running time etc.
The screen shows Auto start CONFIRM by switching this we can Safety Confirm and Run the Machine after confirm.