HEPA Filters Numbering, Purpose:
HEPA Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of G4, F5, F7, F9 and HEPA filters of any machine (except HVAC system) of XX Pharmaceuticals Ltd.
HEPA Filters Numbering, Scope:
The G4, F5, F7, F9 and HEPA filters of any machine of all area of XX Pharmaceuticals Ltd are covered by this SOP.
Definitions / Abbreviation:
[][]N/A
Responsibilities:
[][]The roles and responsibility are as follows:
Engineering Person
[][]To fill up the request form (Annexure – 1) to get the ID of filters of newly installed machines.
[][]To inform validation (engineering) department if there is any replacement of filters.
Engineering (Validation) Department
[][]To give the ID of filters.
Functional Head
[][]To ensure that all the filters of machines are numbered according to this SOP and any Inclusion or Exclusion will be reported to the Validation (Engineering) department within 7 days of Inclusion/Exclusion.
Quality Assurance
[][]To ensure overall implementation of this SOP.
Procedure:
Filter Numbering
[][]Filters will be numbered using the following convention:
AAAA – BBB – CCC – XXX
Where,
[][]AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant. (See the Annexure – I )
[][]BBB: 3 digits numerical code to indicate the machine. (See the Annexure – II)
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter (see Annexure – I). First 2/3 characters indicates the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter of that machine.
[][]For an example, a flat type HEPA filter of grade H14 of Dispensing booth of production area of Solid Block will be numbered according to the following way:
SPRD – 030 – H14F – 001
[][]001 =Sequential Number for that filter
[][]H14F=H14 Grade and Flat type HEPA filter.
[][]030=Numerical code of dispensing booth
[][]SPRD=Solid Production Area
[][]All G4, F5, F7, F9 and HEPA filters of Machines will be tagged containing ID number. Format of filter identification tag is as follows:
ID Number:
[][]The length and height of the box is 4.0 inch and 0.4 inch respectively. Arial font of size 10 shall be used for all the letters. A register ID numbers of filters will be maintained by the validation (Engg.) department.
[][]To get the ID of newly installed filters, the request form for ID (Annexure – II) will be filled up by the respective engineers and sent to the validation (engineering) department. Validation department will provide the sticker of ID and photocopy of the request form after giving new ID.
[][]If a Filter is replaced with a new one, the ID of previous one will be used for the new filter. For this, the respective engineering person will inform the validation (engineering) department and validation engineer will update the Filter list with the newly fitted one and replacement will be noted in the remarks section.
[][]If any filter of new grade (which is not in the list of Annexure – I) is installed, the Annexure – I will be updated by handwriting of Manager, QA with signature and date. The new grade filter will be added on the next version of SOP.
[][]Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easier to handle, the exact format of the approved form can be used (except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form”
Annexure:
Annexure-I : Code for Grade and Type of Filters.
Annexure-II : Request Form for ID Number of filters.
Annexure–III: Register of filters.