SOP FOR OPERATION AND CLEANING AIR JET CLEANING MACHINE
OBJECTIVE: To lay down a procedure for the operation and cleaning of Air Jet cleaning machine.
SCOPE: This procedure is applicable for operation and cleaning of Air Jet cleaning machine placed in Dry Syrup area.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during dry cleaning of bottles through Air Jet cleaning machine.
Officer Production/Supervisor or designee is responsible for execution of SOP and maintaining the records.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the machine 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.
ACCOUNTABILITY: Head of the Production Department.
PROCEDURE:
Precaution & safety
Ensure that no remnants of previous product/batch are present.
Visually check the equipment and area for its cleanliness.
Do not touch the electrode because high voltage is present
Ensure “cleaned” label status on the equipment.
Replace “cleaned” label with “Under process” label.
Get the line clearance from In Process Quality Assurance (IPQA) person and record in BMR.
After decartoning, tap the bottles on table equipped with taflon sheet covered with poly bag. Take the bottles in hand and tap the bottles from mouth end to clear any glass piece in the bottle from manufacturer. After tapping, load the bottles on the turn table in vertical position.
Initially arrange the bottles on the Air Jet cleaning machine in a vertical position.
Operation:
Before start the machine adjusts the distance between ionizer sensor & HDPE/Glass bottle upper part, it should NMT 10 mm.
Put the main switch ‘ON’.
Required compressed air pressure 1.50 to 3.0 kg/cm2 for HDPE bottles and 2.0 to 4.0 kg/cm2 for glass bottle.
Green light indicates the low potential charge is active.
Red light alarm indicates.
For Manual mode: Press manual button to go Manual Mode.
Press ON button to on the main motor and Vacuum motor.
Press ‘ON’ button to On the Solenoid Valve and ON the Ionizer.
Press off button to OFF the Ionizer, Solenoid valve, and Vacuum motor.
Switch “OFF’ the main power after completion of activity.
For Auto mode: Press Auto button to go Auto Mode.
Set the Speed and Press Green button to START the machine.
Press “STOPS” the machine.
Affix duly filled “TO BE CLEANED” Label on the equipment and cleans as per cleaning procedure.
Record the equipment usage in the activity log book.
Challenge Test:
Challenge test for the bottle air wash and ionizer sensor shall be performed by production and shall be verified by IPQA.
Challenge test shall be performed by putting some small pieces of tissue paper in the 6 empty bottles and pass these bottles through the bottle air jet cleaning & ionization machine.
After passing the bottles, check the cleanliness of the bottles for any remaining pieces of tissue paper.
If piece of tissue paper not observed in all 06 bottles and all bottles found cleaned then challenge test is passed.
Fill the log book of challenge test as per Annexure-I of this SOP.
After completion of challenge test, discard all the 06 bottles which were used for challenge test.
Frequency of Challenge Test:
Before start of bottle’s air washing of new batch or days operation.
Whenever bottle air washing machine stopped and re-starts after every breakdown or Lunch, Tea break etc.
Type-A Cleaning procedure:
During batch to batch change of the same product, Type-A cleaning shall be performed.
Switch “OFF” the mains of machine.
Remove the empty bottles if any from machine and discard.
Open the infeed and outfeed invertor and clean the same.
Clean the turn table, conveyor, air jet cleaning machine including railing guide using dry lint free mop.
Clean the nozzles of compressed air with the help of lint free cloth.
Open the clamps of Vacuum generator and clean the bag fitted in it.
Check the bag for the presence of any glass piece. If any glass piece observed in it, record the same in Annexure II of SOP.
Affix “CLEANED” status label and record the cleaning details in usage log book.
Type-B Cleaning procedure:
During product to product change of the different product or drug strength decrease, Type-B cleaning shall be performed.
Switch “OFF” the mains of machine.
Remove the empty bottles if any from machine and discard.
Open the infeed and outfeed invertor and clean the same.
Clean the turn table, conveyor, air jet cleaning machine including railing guide using wet lint free cloth followed by dry lint free mop.
Clean the nozzles of compressed air with the help of lint free cloth.
Open the clamps of Vacuum generator and clean the bag fitted in it.
Check the bag for the presence of any glass piece. If any glass piece observed in it, record the same in Annexure II of SOP.
Mop the machine by using 70% IPA. Mopping shall be done by a lint free cloth.
Ensure that all the parts of machine are clean and dry.
Affix “CLEANED” status label and record the cleaning details in usage log book.