Number of HEPA filter in a room

I

ifserav

Involved In Discussions
#1
#1
Good day

I need information, s there any regulation where be established the number of HEPA filter according to the ISO classification?

Thanks in advance

Sergio Ávila
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
I have not seen any regulation on the number of HEPA filters in a room. Typically, it depends on the number of air changes you intend to have in the clean room; so greater the number of HEPA filters, greater are the air changes.
 
C

cward

Registered
#3
#3
Ajit Basrur said:
I have not seen any regulation on the number of HEPA filters in a room. Typically, it depends on the number of air changes you intend to have in the clean room; so greater the number of HEPA filters, greater are the air changes.
Click to expand...
Would you know or know how I could find out how many air changes I would need for a class 8 cleanroom?
 
N

noumanumar

Registered
#5
#5
Ajit Basrur said:
I have not seen any regulation on the number of HEPA filters in a room. Typically, it depends on the number of air changes you intend to have in the clean room; so greater the number of HEPA filters, greater are the air changes.
Click to expand...
Hi,

Just wanted to ask if there is any ISO standard requirement for air changes or is it just a simple design element for the HVAC manufacturer?

Thanks!
 
Ninja

Ninja

Looking for Reality
Trusted Information Resource
#7
#7
I agree with Ajit... but don't lose sight of one particular fact... "The purpose" as it were.

It isn't about number of inlets (filters).
It isn't about number of air changes.
It's about the air. (It's about whether or not the result meets the needs.)
All the rest are tools you use to get there.

As I've said before, my living room (No HEPA, curtains, carpet, upholstered furniture, plants) is ISO8.
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#8
#8
Ninja hit the nail on the head!

Before you decide on how many HEPA filters to be used, there are other parameters namely, which cleanroom class are you looking for (ISO Class 5, or 7, 8 etc.), what is the process to be employed in the cleanroom, does that process generate particles and is it heavy or moderate or low; number of air changes needed to keep the room "clean" (meet the particulate and if required, microbiological; type of HEPA filter; type of filtration etc.

Your cleanroom experts will have all this info. And as Ninja explained, it is paramount that the quality of air must meet the requirements.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
H Notified Body Number with CE Mark CE Marking (Conformité Européene) / CB Scheme 4
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
R UDI Number Identification EU Medical Device Regulations 5
G Number of Destructively Tested Devices Needed for Ethylene Oxide Validation Other Medical Device Related Standards 4
D Number of people to be interviewed during an internal audit? Internal Auditing 10
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
N How to find column number for the last non-empty column? Using Minitab Software 0
S Business Number versus Company ID? Canada Medical Device Regulations 3
B Document Issued with incorrect Document number code Document Control Systems, Procedures, Forms and Templates 3
M Are you allowed to reuse the same asset number if the device was replaced? General Measurement Device and Calibration Topics 10
D Control Number for Class III and IV devices Canada Medical Device Regulations 1
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
K How can Acceptance Number and Reject Number be larger than Sample Size on Z1.4 Table? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
D Determining the the maximum number of reprocessing cycles of attachments CE Marking (Conformité Européene) / CB Scheme 2
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 7
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
Q How is Medical Device Number (MDL) assigned to companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 19
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
I Number of decimals in equation calculated by MiniTab Using Minitab Software 0
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Z Two Payment Identification Number (PIN) for the same order in DFUF website 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
G Belgium - How do I get an enterprise CBE Number Other Medical Device Regulations World-Wide 0
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
S How to number and control translated SOPs - Three languages Document Control Systems, Procedures, Forms and Templates 4
qualprod Calculate number of people in processes, considering cycle time/takt time = quantity of people Lean in Manufacturing and Service Industries 9
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
J DoE - Number of runs in Plackett-Burman (Minitab) Using Minitab Software 2
G Heat Number on CofC - Stainless steel tube Manufacturing and Related Processes 2
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
qualprod What tier number fits in a company producing paper labels stuck on automotive parts? IATF 16949 - Automotive Quality Systems Standard 7
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
J Question on very low NDC number with tolerable GRR ratio's Capability, Accuracy and Stability - Processes, Machines, etc. 7
S Is Lot Number required in addition to UDI serial number? Other Medical Device Regulations World-Wide 7
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
D IMDS for machining - Can my customer request a IMDS number for a part? APQP and PPAP 2
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0

Similar threads

Top Bottom