Trimming Machine, Purpose :
Trimming Machine, The purpose of this SOP is to describe the operation procedure of Trimming Machine in order to comply with cGMP standard.
Trimming Machine, Scope :
The scope of the procedure is applicable to the Trimming machine at the Dialysis Fluid Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]Trimming machine is a precision machine. It is covered by metal body. This machine consisting of a lever-operated knife and adjustable guides for container surfaces true to required angle.
Operator/Supervisor
[][]Operation and cleaning of the Trimming machine
Executive/ Sr. Executive
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Preparation and timely review of the SOP.
Manager Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation, cleaning and maintenance procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. Master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure :
Precaution(s) :
[][]Ensure that no unauthorized person gains operational access to the machine.
[][]Care must be taken to ensure that the drive units and accessory parts cannot be switched on inadvertently after servicing or maintenance work.
Instruction :
[][]Use Air (1 to 1.5 bar) during operation of Trimming machine.
[][]Keep the machine dry and cool environment.
[][]Keep the air pipe free from any other instrument, naught and coiling during operation and after completion of job.
Machine Assembling :
[][]Setting of in air pipe line of the machine.
[][]Ensure that the air pipe locks are tightly locked and cleaned.
Machine Operation :
[][]Check the machine that there is no abnormal setting of pipe in the machine.
[][]Connect the main electric supply with the socket.
[][]“On” the electric power.
[][]Then “On” the machine control power.
[][]After completion of assembling
[][]Placed the well required position of HPDE Container.
[][]Machine lever-operate HPDE container up the adjustable knife.
[][]Then Knife cutting the container mouth surfaces true to required.
Machine Dismantling :
[][]First “OFF” the air line valve and then remove the pipe from the source and the machine.
[][]“OFF” the machine control power.
[][]Then “OFF” the electric power.
[][]Remove the main power supply form the socket.
Machine cleaning :
Remove dusts from the machine with a dry lint free cloth.
Clean all the machine parts (air pipe and metal parts) with dry lint free cloth.
Annexure:
Annexure I Equipment Use Log Book