HVAC System Filters Numbering, Purpose:
HVAC System Filters Numbering, The purpose of this SOP is to define the procedure for the establishment of identification number of terminals/filters of HVAC system of XX Pharmaceuticals Limited.
HVAC System Filters Numbering, Scope:
All types of filters, diffusers and return risers/grilles of HVAC system of both Solid and Sterile Blocks are covered by this SOP.
Definitions / Abbreviation:
[][]HVAC: Heating Ventilation and Air Conditioning.
[][]HEPA: High Efficiency Particulate Air.
[][]AHU: Air Handling Unit.
Responsibilities:
[][]The roles and responsibility are as follows:
Engineering Person(related to HVAC)
[][]To fill up the request form (Annexure – 1) to get the ID of newly fitted filters/diffusers/return grilles.
[][]To inform validation (engineering) department if there is any replacement of terminals/filters.
Engineering (Validation) Department
[][]To give the ID of filters/diffusers/return grilles.
[][]To maintain a register for terminals/filters of HVAC system.
Functional Head
[][]To ensure that all the terminals/filters of HVAC system are numbered according to this SOP and any inclusion or exclusion is reported to the Validation (Engineering) department.
Head of Quality Assurance
[][]To ensure overall implementation of this SOP.
Procedure:
[][]Supply Diffuser and Filter Numbering
[][]Filters will be numbered using the following convention:
[][]AAAA – BBBB – CCC – XXX
Where,
[][]AAAA/AAA/AA: 4/3/2 characters to indicate the area of the plant.
[][]BBB/BB/B: 3/2/1 characters to indicate the diffuser and filter.
[][]For a diffuser and filter combination the code will be ‘DF’. If there is a swirl diffuser and filter, the character will be ‘SDF’.
[][]For a supply terminal without filter, the code will be only ‘D’ for diffuser. Only ‘F’ is used for the filters inside the AHUs.
[][]CCCC/CCC: 4/3 characters to indicate the grade and type of filter.
[][] First 2/3 characters indicate the grade of filters and last character indicates the type of filter (bag type, flat type etc.).
[][]The character will be 000 in case of having no filter with the supply diffuser.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of filter in an area.
For an example, a terminal flat type HEPA filter of grade H13 of Production Area of Sterile Block will be numbered according to the following way:
SPRD – DF – H13F – 001
001=Sequential Number for that area
H13F=H13 Grade and Flat type filter.
DF =Diffuser and Filter
SPRD=Sterile Production Area
Return Grille/Riser, Filter and Exhaust Grille Numbering
[][]All diffusers and return grilles of HVAC system of the plant 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.
[][]BBB: 3 characters of which first 2 characters indicate either low return riser or high return.
[][]Last character indicates filter or grille. ‘RR’ or ‘HR’ is used to indicate the low return riser and ceiling return respectively. ‘
[][]F’ and ‘G’ is be used for last character to indicate the filter and grille correspondingly. For exhaust grille the code will be 2 letters ‘EG’.
[][]CCC: 3 characters to indicate the filter grade and type of filter.
[][]If there is no filter in the return, the character will be 000.
[][]XXX: Three digits numerical code to indicate the sequential number of the same type of terminals/filters of a particular area.
[][]For an example, a low return riser of production area of general block with a G4 bag type filter is identified according to the following way:
PRD – RRF – G4B – 001
001=Sequential Number.
G4B=Filter grade and type
RRF =Low return riser with filter
PRD=Solid Block Production Area
[][]All terminals/filters of HVAC system 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 of Terminal/Filter ID will be reserved in the validation (Engineering) department. (See Annexure – III).
[][]To get the ID of newly installed filters/terminals, 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 Terminal/Filter is replaced with a new one, the new ID no. will be provided and the previous ID no. will not be used again.
[][]If any filter of new grade (which is not listed in the Annexure – I) is installed, the new filter will be added in the Annexure – I by handwriting of Head of QA with signature and date without reviewing the whole SOP. The Annexure – I will be added on the next version of this 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 New Terminal/Filter of HVAC system.
Annexure-III : Register of Terminal/Filter of HVAC system.