Converting an ISO Class 8 Cleanroom to ISO 7

T

TheBigChill

#1
Hi there,

I'm not quite sure that this is the best place to ask this but, as a recently appointed "Cleanroom Coordinator", I've been tasked with implementing an ISO 7 clean-space within our existing ISO 8 cleanroom.

Our customer is requesting that their product be built in an ISO 7 clean-space, and I'm currently weighing different options regarding how I can implement this. Below are my options, ordered from most to least preferred.

Options:

1) Re-work existing ISO 8 cleanroom to ISO 7 level. (What's involved?)
2) Install modular IS0 7 softwall cleanroom in existing ISO 8 area (encompassing project specific tooling and workspace).
3) Install vertical laminar flowhoods over the project specifictooling and workspaces.

In terms of particle counts, we actually monitor data daily, and with the exception of 5 micron particles we are well within ISO 7 limits. Should I be looking more at better gowning and operator contamination controls, or a better cleaning protocol? Basically, that 5 micron count is all that's keeping us from being ISO 7.

We currently don:

-Bouffant caps.
-Beard covers.
-Washable ESD frocks.
-Disposable ESD cleanroom gloves.

HEPA Coverage:
-5 HEPAS providing ~10% ceiling coverage.

Air changes will be calculated shorty, but I'm fairly certain even those already meet ISO 7, or can with some tweaking of fan speeds and air handler damper adjustments.


Perhaps making shoe covers and sleeve guards (we have a cuff exposure issue) mandatory, that will help.

Thoughts?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Converting an ISO 8 Cleanroom to ISO 7

What does your count data tell you about sources of particles? I.e., if the room has less of a 5 micron issue with systems running but no persons working; or less of an issue with persons working but not circulating; or with some kinds of work-activity/products compared to others; or in parts of the room where particular activity occurs or a particular source may be concentrated. That should point toward what to change first if you choose to bring the whole room to 7.

Is the cheapest solution the one that will be chosen? If so, I assume that the cheaper of the modular and hoods ideas would determine the cost threshold for whole room modifications. Does it seem plausible that the cost of whole room upgrades could fit within that budget?
 

BradM

Staff member
Admin
#3
Re: Converting an ISO 8 Cleanroom to ISO 7

Miregmgr points are sound.:agree1: Basically you need to determine what the cleanroom (irrespective of people and activities) is capable of reproducing.

I've seen situations where clean suites are constructed to meet requirements two grades better than what they were currently classified at. I've also seen situations where the suites were barely passing their current desired specification.

I assume the HEPA filters are testing for downstream velocity and are acceptable. Also, I assume that differential pressures are acceptable.

So, if the room (at rest) can meet the specifications, then to your point, you will need to minimize the burden carried in/out of the room.
 
T

TheBigChill

#4
Re: Converting an ISO 8 Cleanroom to ISO 7

What does your count data tell you about sources of particles? I.e., if the room has less of a 5 micron issue with systems running but no persons working; or less of an issue with persons working but not circulating; or with some kinds of work-activity/products compared to others; or in parts of the room where particular activity occurs or a particular source may be concentrated. That should point toward what to change first if you choose to bring the whole room to 7.

Is the cheapest solution the one that will be chosen? If so, I assume that the cheaper of the modular and hoods ideas would determine the cost threshold for whole room modifications. Does it seem plausible that the cost of whole room upgrades could fit within that budget?

Because particle counts for all sizes are within ISO 7 spec with the room "At Rest", that tells me that our biggest contamination burden is likely personnel. Shortly after a couple of people walk in the room ("In Use"), the 5 micron particle count goes outside ISO 7 spec, while all others stay in. Having said that, it's a bit perplexing as to why this happens, as we don all suggested and required apparel. Perhaps we need to look at upping our cleaning standards?

In terms of processes within the cleanroom that contribute to contamination, we use primarily hand tools and electronics test equipment, with three, slow rotating fixtures. I'd consider them pretty low contributors to contamination. Occasionally soldering takes place, and even with a elephant trunk sucking the smoke away, sometimes our particle counter goes nuts.

The cheapest option won't necessarily be the chosen option, but we do have an unused modular softwall cleanroom, and 4 HEPAs / FFUs that are currently unused and could be applied to the project. The issue with the modular softwall room is ceiling height; Our ISO 8 cleanroom has an 8' ceiling, and the top of the HEPAs for the softwall room are also around 8'. You must have 1' of clearance between HEPA ceiling outlets and HEPA inlets of hoods or modular cleanrooms.

Some Technical Data:

- 5% of our ceiling is HEPA filters (I misspoke earlier).
- We have 28 Air Changes / Hour.
- 60% Humidity and 69F temp.
- Room pressure differential is .08.

In order to convert to ISO 7, we'd have to add ~ 10 more HEPAs to achieve 16% ceiling coverage, and fine-tune the fan speeds on all units in order to achieve 40-60 Air Changes / Hour. (Based on Flanders Air cleanroom design guidelines.)


One thing I'm currently handling is our personnel and their bad habits of bringing paper, ESD cardboard, and other non-cleanroom approved material into the room. Additonally, we don't have a gowning room. People use the tacky mat outside the door, and gown-up in a corner near the entry door. This is also changing, as we're building a gowning room.

Thanks for the responses, guys, and any help is appreciated.
 

BradM

Staff member
Admin
#5
Re: Converting an ISO 8 Cleanroom to ISO 7

I wished all posters provided details like this. :agree1:

Because particle counts for all sizes are within ISO 7 spec with the room "At Rest", that tells me that our biggest contamination burden is likely personnel. Shortly after a couple of people walk in the room ("In Use"), the 5 micron particle count goes outside ISO 7 spec, while all others stay in. Having said that, it's a bit perplexing as to why this happens, as we don all suggested and required apparel. Perhaps we need to look at upping our cleaning standards?
I couldn't imagine the 5 micron shooting up, and not the .5 micron. I agree with your statement about cleaning. Something (or somebody) is bringing in some nasty stuff.

Have you measured with increased gowning requirements in place?

In terms of processes within the cleanroom that contribute to contamination, we use primarily hand tools and electronics test equipment, with three, slow rotating fixtures. I'd consider them pretty low contributors to contamination. Occasionally soldering takes place, and even with a elephant trunk sucking the smoke away, sometimes our particle counter goes nuts.
Do you perform this work in flow hoods?

The cheapest option won't necessarily be the chosen option, but we do have an unused modular softwall cleanroom, and 4 HEPAs / FFUs that are currently unused and could be applied to the project. The issue with the modular softwall room is ceiling height; Our ISO 8 cleanroom has an 8' ceiling, and the top of the HEPAs for the softwall room are also around 8'. You must have 1' of clearance between HEPA ceiling outlets and HEPA inlets of hoods or modular cleanrooms.
It's nice to have options. :D

Some Technical Data:

- 5% of our ceiling is HEPA filters (I misspoke earlier).
- We have 28 Air Changes / Hour.
- 60% Humidity and 69F temp.
- Room pressure differential is .08.
Is that room differential to.. open (unclean air) that seems kind of low. I would like to see that up higher if possible. Now... if you were talking a cascade scenario and this was three tiers up, .08 may be all you can get. Are they going in and out of the door a lot? Is there a gown room leading in?

One thing I'm currently handling is our personnel and their bad habits of bringing paper, ESD cardboard, and other non-cleanroom approved material into the room. Additonally, we don't have a gowning room. People use the tacky mat outside the door, and gown-up in a corner near the entry door. This is also changing, as we're building a gowning room.
Um... maybe if I actually read everything, I could see your answers to my questions! :D:tg:

Personally, I think having a gown room will make a big difference. Since you already have this under Change Control and such, can you up the air flow in the clean room, up the air flow in the gown room, and then have cascading positive differentials? I think that would help a lot.
 
Thread starter Similar threads Forum Replies Date
Q Converting Manufacturing Drawings from a Contract Supplier ISO 13485:2016 - Medical Device Quality Management Systems 7
N Converting ETO Residual Limits from PPM to mg ISO 13485:2016 - Medical Device Quality Management Systems 6
P Converting DMF III into eCTD (Electronic Common Technical Document) Medical Information Technology, Medical Software and Health Informatics 4
N Converting Paper Records to Electronic Format Records Document Control Systems, Procedures, Forms and Templates 6
V Converting Newtons to Newton Meters APQP and PPAP 4
optomist1 Converting Defect Rate To Capability index Capability, Accuracy and Stability - Processes, Machines, etc. 11
B Conversion and Rounding Standard for converting metric to english and vice versa Other ISO and International Standards and European Regulations 4
A Converting 1-Sided Design Tolerance to a Bilateral Tolerance Statistical Analysis Tools, Techniques and SPC 8
D Converting to Electronic Document Control - Procedure Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Stijloor Converting a Bear... Funny Stuff - Jokes and Humour 0
optomist1 ASME GD&T Certification Test - Converting Coordinate Tolerances to Profile Tolerances Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J Converting SOUP to "SOKP" ... IEC 62304 - Medical Device Software Life Cycle Processes 1
M Converting PowerPoint Presentations into MS Word Documents After Work and Weekend Discussion Topics 6
N Thermocouple Calibration - Digital Display vs. Converting the Millivolt into ?C General Measurement Device and Calibration Topics 8
R Converting Best Measurement (BMC) to Calibration & Measurement Capability (CMC) Nonconformance and Corrective Action 2
A Basic Math training - I.e. fractions converting from inches to mm, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I Converting mG(milli g's of acceleration) to dB(deciBel) Misc. Quality Assurance and Business Systems Related Topics 20
J Converting solid model formats for a Calypso CMM Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Curve Surface Roughness Measurement & Converting Ra to Rz General Measurement Device and Calibration Topics 8
Sidney Vianna Converting PowerPoint presentations into video - software recommendations? After Work and Weekend Discussion Topics 12
A CMM Software Conversion - Converting from Zeiss/Calypso to Brown & sharpe PCDMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
ScottK Learning about converting an AutoCAD .dwg to a .STEP file Manufacturing and Related Processes 5
B Converting from QS9000 to TS 16949 ... HOW? WHO? HOW MUCH? IATF 16949 - Automotive Quality Systems Standard 2
J Converting torque to pressure - One for the Math Folks Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Converting ISO9001:1994 to new ISO9001:2000 - Transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Converting to Process Audits - Seeking: Process Audit Form layout Process Audits and Layered Process Audits 4
J Table for converting Cp values into corresponding Capability % Statistical Analysis Tools, Techniques and SPC 1
J Converting DPMO to SIGMA - Seeking Forumula Statistical Analysis Tools, Techniques and SPC 16
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 8
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0

Similar threads

Top Bottom