Filter Integrity Test Machine, Purpose :
Filter Integrity Test Machine, The purpose of this SOP is to describe the operation and sanitization procedure of filter integrity test Machine in order to comply with cGMP standard.
Filter Integrity Test Machine, Scope :
The scope of the procedure is applicable to the filter integrity test machine at the DFU Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]Filter integrity test machine is a high precision machine. It is covered by special sealing profile with metal body, large size (10 inch) of touch PLC windows. This machine is associated with data control unit with networking system. BPT/ DFT/BDT are loaded into the machine by Supplier.
Responsibilities:
[][]The roles and responsibilities are as follows:
Operator/Supervisor
[][]Operation and cleaning of the filter integrity test machine
[][]Maintaining operation and cleaning log book.
Executive, Production
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
Manager Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Head of 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.
[][]The cover must be kept in close position during operation.
Instructions:
[][]Use Nitrogen (7 to 8 bar) during operation of filter integrity testing.
[][]Keep the machine dry and cool environment.
[][]Keep the nitrogen and other silicon pipe free from any other instrument, naught and coiling during operation and after completion of job.
Machine Assembling :
[][]Remove the SS cover of the Upper side of the machine.
[][]Setting of in and out pipe line of the machine.
[][]Ensure that the 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.
[][]Open the flap of automatic data controller (which is situated on the Upper side of the machine) & on the UPS switch.
[][]On the control power of automatic data controller.
[][]Login the password.
[][]After completion of assembling,
[][]Fix the recommended test method setting.
[][]Fix the pre-pressure on the nitrogen pressure gauge setting.
[][]Fix the main-nitrogen pressure setting.
[][]Log in by the main user.
[][]Select the “Program Test” on PLC.
[][]Press the “Page Down” on the PLC of machine.
[][]Select the “Test Technique” (Like: BPT, DFT, BDT).
[][]Press the “Page Down” On PLC of machine.
[][]Set the minimum and maximum range of nitrogen pressure (3000mbar to 4000mbar) as per recommendation of filter certificate.
[][]Press the “Page Down” on PLC machine.
[][]Then set the Product Name, Batch No., and Filter Identity No. on the PLC of machine.
[][]Press “Page Down” and press “Save” button.
[][]Then check all the pipe line again and plug on the nitrogen out line to the filter housing.
[][]Placed the well wetted (soaked by purified water) filter (02 micron) at “O” ring of the filter housing.
[][]Cover the filter housing and tightly locked with TC clam.
[][]After obtaining required steps lock the solution “In” line “OFF” with dead valve and TC clam tightly.
[][]Then press the “Start” button to start the filter integrity testing.
[][]During operation if we want to change (increase/decrease) any parameter or batch no. we have to Press “Stop” button and then put the data again.
Machine Dismantling :
[][]First “OFF” the nitrogen line valve and then remove the pipe from the source and the machine.
[][]Remove the nitrogen line from the filter housing.
[][]Press the “Main Menu” on the PLC of the machine.
[][]Remove the main power supply form the socket.
Machine cleaning :
[][]Remove dusts from the PLC of the machine with a dry lint free cloth.
[][]Clean all the machine parts (silicon pipe and metal parts) with dry lint free cloth.
Annexure:
Annexure I Equipment Use Log Book