1.0 Purpose: To lay down a procedure operation of the pouch sealing machine.
2.0 Applicable to This SOP applies to Pouch Sealing machines located on the production floor.
3.0 Responsibility: 3.1 The line coordinators trained in cleaning and operation processes shall carry out the process of Bung processor.
3.2 Scientific officers/ Sr. scientific officers shall supervise the process.
3.3 Production Manager shall be responsible for the implementation of SOP.
3.4 Head-Quality Assurance/designee shall be responsible for compliance of SOP.
4.0 Safety consideration:
4.1 Do not touch the hot surface of the machine.
4.2 Do not transport the machine on the peel edge setting.
4.3 Do not carry the machine when power is connected to the machine.
5.0 The Equipment:
5.1 Pouch sealing machine
6.1 Insert the plug into the power socket and switch on the machine.
6.2 The Operating face of the machine has the following features.
6.3 Data input:
6.3.1 After approximately 30 sec, the machine displays the date, time, actual temperature, and set temperature.
6.3.2 The machine will reach the set temperature after about 5.0 minutes.
6.3.3 Adjust the temperature of the machine (if required) by pressing the “TEMP” button and set the temperature NMT 185°C (NLT 170 °C), then store the set point by pressing the “OK” button.
6.3.4 Check the date and time of the machine, adjust if required by pressing the “DAT” button, and set the date in DD-MM-YY format and time in hh: mm format. Store the data by pressing the “OK” button.
6.3.5 Adjust the Expiry date of the packed material by pressing the “EXP” button. Give the expiry date in DD-MM-YY format by selecting the additional period over the current date and saving the data by pressing the “OK” button.
6.3.6 Input the charge number of the sterilization cycle, piece number of the item to be charged in the cycle by pressing “LOT/CHARGE”, “COUNT”, respectively, save the data by pressing the “OK” button.
6.3.7 Add the additional text information by pressing the “down arrow key” and typing the text; save the data by pressing the “OK” button.
6.4 Sealing operation
6.4.1 Adjust the peeling edge width (5mm to 30 mm as per the requirement) of the pouch to be sealed.
6.4.2 Inset the sterilization pouch in the side port of the machine; the drive in the machine should draw the pouch and seal the same.
6.4.3 Remove the sealed pouch and allow cooling briefly.
6.4.4 Verification of seal done as per validation protocol no. VP/QA/XX.
Master Copy: Archived with Quality Assurance Department
Controlled Copy: Production Department
Subsequent Controlled copies: Departments making requisitions
Related post: SOP Operating of Vials Labeling Machine
VF: Vaccine Formulation
QA: Quality Assurance
SOP: Standard Operating Procedure
NLT: Not less then
NMT: Not more then
°C: Degree centigrade