Induction Sealing Machine, Purpose :
Induction Sealing Machine, The purpose of this SOP is to describe the Set up, operation, and cleaning of Induction Sealing Machine (Model: IND-130HC ) in the Dialysis Fluid Unit of XX Pharmaceuticals Limited.
Induction Sealing Machine, Scope :
This SOP is applicable for the Production and Primary Packaging of Dialysis Fluid Unit XX Pharmaceuticals Limited.
Definition / Abbreviation :
[][]SOP: Standard Operating Procedure.
[][]Induction Sealing: Non-contact method of eddy (electromagnetic current) heating to a metallic disk that accomplishes the hermetic sealing.
Responsibilities :
[][]The Roles and Responsibilities are as follows :
Operator
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Quality Assurance
[][]To approve the Document.
Annexure
Annexure-I: Operation Logbook of Induction Sealing Machine ( Model: IND-130HC )
Precautions :
[][]Never unscrew the Sealing Head valves of the handle.
[][]Have the meter serviced only by the Mettler Toledo service.
[][]Any spillage should be wiped off immediately some solvents might cause corrosion of the housing.
[][]Avoid the following environment influences:
[][]Powerful vibrations
Operation:
[][]Ensure that working area is clean.
[][]Switch on the power its main.
[][]Power on the Sealing Machine.
Set the Sealing Temperature and Time.
[][]Check the Time 0.8 sec and temperature 250° c.
[][]Placed the Aluminium Sealing Foil top of the Container (Filing Mouth).
[][]Sealed the Cap (HDPE) With Aluminium Sealing Foil.
[][]For Induction Sealing, Press wait until a stable endpoint (0.8 sec) has been reached.
[][]Hear the “beep” sound.
[][]See the sign (Blue Light) at the Front side of the display.
[][]Put Off the Induction Sealer and then Transfer the Sealed Container.
[][]Collect the Filled Container For Next Sealing.
[][]Press OFF if any Emergency Problem Arises.
[][]Record the Sealing data in the Operation Logbook of Sealing Machine (Model: IND-130HC) as per Annexure-I.
[][]Power off the Sealing Machine.
[][]Switch off the power from its main.
Cleaning and maintenance:
[][]Wipe the Induction Sealing Machine with dry cloth.
[][]The Body of the instrument may attack by KDF Solution.
[][]Wipe away any spillage immediately.