Filter cleaning procedure, Purpose:
Filter cleaning procedure, The purpose of this SOP is to define the cleaning procedure of filters of various process machines of Production, Product Development and Warehouse departments.
Scope:
This Standard Operating Procedure applies to the fluid bed dryers, coating machines, dust collectors of tablet compression machine, laminar air flow unit, dispensing and sampling booths of production, product development and warehouse department which are located of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]FBD: Fluid Bed Dryer.
[][]HEPA: High Efficiency Particulate Air.
[][]EHS: Environment Health and Safety.
[][]PPE: Personal Protective Equipment.
[][]SOP: Standard Operating Procedure.
[][]W.C: Water column (pressure unit).
[][]PD: Product Development.
[][]PAO: Poly Alpha Olefin.
Responsibilities:
[][]The roles and responsibilities are as follows:
Engineering (Validation) Department
[][]Preparing the SOP and revise it when necessary.
Engineering (Maintenance) Department
[][]To provide necessary support to the technician for cleaning the filters.
[][]To check that the filters are properly cleaned/changed.
[][]To check that the log book is properly filled.
Technician
[][]To clean/change the filters when necessary.
Head of Engineering
[][]To ensure filters are cleaned/changed according to the SOP.
Head of Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precautions:
[][]All operational work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use all Personal Protective Equipments such as goggles, masks, hand gloves etc. during cleaning/changing the filters.
[][]Disconnect the electrical power before opening the filters.
[][]Ensure all utilities before doing any kind of cleaning/changing task.
Cleaning and Changing procedure:
[][]Filters of FBD: There are five types of filters in FBD such as pre filter, medium filter, HEPA filter, product retaining filters and the cartridge filters of dust collector.
[][]To clean the cartridge filters and pre filters following procedures are followed:
Dismantle the filter from the filter housing.
[][]Clean the filters using compressed air at a pressure of 1-2 bar.
[][]Then take the filters to the filter cleaning area and keep the filters drowning in the potable water for 2-3 hours.
[][]Then take out the filters from the water and partial drying is done by blowing compressed air at a pressure of 1-2 bar.
[][]After that, dry the filters under the sunlight.
[][]Finally, compressed air is used after sunlight to remove any dirt from the filters.
[][]Fix the filter into the filter housing.
[][]The pre filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]The cartridge filters are cleaned if the differential pressure is equal to or more than 4 in. of W.C. An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The medium filters and HEPA filters of inlet air handling unit are checked on every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]The product retaining filters are cleaned through production SOP.
[][]Filters of Coating machine: There are four types of filters in the coating machine such as: pre filter, medium filter, HEPA filter and cartridge filters of dust collector
[][]The cleaning procedure of pre filter and cartridge filter of dust collector is as same as it is described in the previous section The filters are cleaned after every 15 days. An exchange is only required, if dirt is visible or any part of the filter is worn out.
[][]An exchange of the filters is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filters is worn out.
[][]The medium filter and HEPA filters of inlet air handling unit are checked every 3 months. Change the filters if the differential pressure is equal to or more than 4 in. of W.C.
[][]Filters of Dust Collector of Tablet Compression machine: They are cleaned using compressed air at a pressure of 1-2 bar after each batch of operation. Full cleaning (as per the procedure described in the previous section is done after 5 batches of operation.
Filters of Dispensing and Sampling Booth:
[][]There are pre filter, medium and HEPA filters in dispensing and sampling booths.
[][]The pre filters are cleaned on every month according to the procedure described in the previous section.
[][] The medium filters are cleaned using compressed air at a pressure of 1-2 bar when the differential pressure across the filter is equal to or more than 250 Pa.
[][]An exchange is only required, if dirt is visible or the differential pressure does not decrease after cleaning or any part of the filter is worn out.
[][]The HEPA filters are changed when the differential pressure across the filter is equal to or more than 400 Pa.
Filters of Laminar Air Flow unit of Dialysis Fluid area:
[][]There are two types of filters in the Laminar Air Flow unit such as: Pre filter and HEPA filter.
[][] The cleaning procedure of pre filter is as same as it is described in the previous section .
[][]The pre filter will be cleaned after every 15days.
[][]The HEPA filter will be checked on every month and will be changed if the differential pressure exceeds 250 Pa.
[][]An exchange is only required, if dirt is visible or any part of the filters is worn out.
[][]The filter integrity test (PAO test) of all the HEPA filters will be performed on every year.
[][]The filters will be changed in case of failure to meet the acceptance criteria of this test.
The technician will fill up the log books of filter cleaning/changing after cleaning or changing the filters.
Annexure:
Annexure – I: Log book of cleaning the filters of process machines
Annexure – II: Log book of changing the filters of process machines