Acceptable Visible Particulate Size on Sterile Medical Devices

Q

qualgk

#1
I've been searching the internet for the last two days to find a standard, a book or anything that will tell me what visual particulate size is acceptable for sterile medical disposables. No luck there.

Can anyone give me some suggestions or point me to a website I can reference in my procedure? Thanks -- Michael
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

None of our Class-I-device customers will accept any visible particulate.

As far as I know, there is no relevant standard. My guess as to why is that it's a simple go/no-go test...if you can see any particulate or other contamination, especially with the naked eye, both the product and the underlying production process are unacceptable.
 
Q

qualgk

#3
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

Well thank you for responding.

Okay, so what you're saying is anything that can be visible at 18" (or other required viewing distance) on the TAPPI Chart is unacceptable for the customer.

See, we had a customer in my last job that had a specific requirement, but that was for a class III electronic medical device with no sterile accessories. What's my utmost concern in this case, however is from a microbiological point of view. What particle size and surface area (i.e. how many particles over a square millimeter pose) a possible threat to the bioburden?
 
M

MIREGMGR

#4
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

Our product handling and packaging operations are conducted in rooms that are third party tested and rated to ISO Class 8 per the ISO standard family 14644. Note however that neither FDA, EC or HC specify a minimum acceptable Class.
 
Q

qualgk

#5
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

So it would be an internal standard decided based upon what the customer recommends. Good advice. Thanks.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

None of our Class-I-device customers will accept any visible particulate.
Visible - by who? under what conditions (lighting, magnification, distance etc.). It's a slippery slope, seen that in action.

As far as I know, there is no relevant standard.
That's also what I know. I have searched for one or for clinical guidance for much longer than 2 days.

:(
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

Our product handling and packaging operations are conducted in rooms that are third party tested and rated to ISO Class 8 per the ISO standard family 14644. Note however that neither FDA, EC or HC specify a minimum acceptable Class.
Certified clean rooms are a good start but they are far from assuring no visible particles. Especially ISO 14644 class 8 ones.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

What's my utmost concern in this case, however is from a microbiological point of view. What particle size and surface area (i.e. how many particles over a square millimeter pose) a possible threat to the bioburden?
Hi,

Although the issues may be related, there is no direct correlation between the presence of particulate matter and bioburden (at least none that I know of). You colud have high bioburden levels with quite little particulate matter, and, although less probable, higher levels of pariticulate matter presence with resulting acceptable bioburden levels.

You should establish the requirements and controls for these two topics independently.

Bioburden levels should be established upon applicable standards, as part of establishing, validating and maintaining the sterilization process(es).

Particulate matter levels should be established upon clinical application, client requirements and (with the lack of a standard) your own risk management process. It matters a lot what sort of device you make and for what/how it is used.

Operating inside standard certified clean-rooms may be a viable way to control both, once documented requirements are in place.

Cheers,
Ronen.
 
M

MIREGMGR

#9
I fully agree that ISO 14644 is minimally relevant to control of macro particles. It however is a shorthand way to describe the standardized measureables in our working environment, in a way that medical/pharma-packaging-experienced people understand.

And I certainly agree on the nature of bioburden manageability.

After considerable effort and experience at engineering sources of variability out of the controlled environment and at understanding the contaminant population, microparticle measurements have become indirect indicators for us of what we really need to control, i.e. macroparticles and sterilization-affecting bioburden.
 
Q

qualgk

#10
Re: Acceptable Visible Particulate Size on Sterile Medical Devices ... HELP!!!

@Ronen -- we're working under standard lighting conditions (flourescent lights), at a distance of about 18". It is hard to get everything completely free of particulate, simply because people have hair, other processes may generate a menial amount of particulate, be it plastic parts that have flash that comes off or something blown onto the piece by a fan on a piece of equipment that has just a little dust ... the list goes on.

Zero particulate was the standard I submitted. Whether or not people will agree with it, who knows. Our clean room is ... not exactly a cleanroom ... we have class 100 hoods where most of the assembly and packaging operations take place, with the exception of tray sealing and adhesive bonding.

We'll see how that turns out.
 
Thread starter Similar threads Forum Replies Date
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Fungal counts acceptable in class 1000 clean rooms? Other ISO and International Standards and European Regulations 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
samer Acceptable limits for Spills - Tracking Hydraulic Spills ISO 14001:2015 Specific Discussions 3
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Gage R&R Acceptable (10-30%), deduct Total Variation from Tolerance Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Q Acceptable calibration accuracy of a 60" linear measuring device General Measurement Device and Calibration Topics 16
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Acceptable NDC for %GR&R part inspection to Tolerance (%Tolerance) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
S Dates on Labels acceptable to the USA - GS1 General Specification 3.4.4 Other US Medical Device Regulations 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
W Unattached (stand-alone) Forms acceptable for AS9100C? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
V Why Gauge R&R 10% is acceptable for variable instruments ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
X Acceptable methods to store and archive records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Is it acceptable to audit to the Nuclear Principles? Quality Manager and Management Related Issues 9
I Is it acceptable it is to list new products under an existing 510(k)? Other US Medical Device Regulations 14
S If this EN ISO 11137 certificate acceptable for Contract Sterilization? ISO 13485:2016 - Medical Device Quality Management Systems 2
D What is satisfactory & acceptable for Coliform - Staphylococcus - Hands and Surfaces Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
C Lowest Acceptable Grade for Master Gage Set Calibration and Metrology Software and Hardware 1
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Is a ndc less than five is also acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
T Technical regulations that determine the acceptable limits of cigarettes General Measurement Device and Calibration Topics 4
L IEC 60601-1 3rd edition Clause 9.2.2 Trapping Zone (Acceptable Gaps) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is it acceptable to sterilize products without claiming and labeling "sterile" ? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is embedding documents within a Contract an acceptable practice ? Contract Review Process 9
B Non Acceptable % Tolerance Result - Decrease Sorting Limits Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
F ANSI ASQ Z1.4 - Is the following process acceptable? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Maximum acceptable Tolerance - Uncertainty Ratio (TUR) General Measurement Device and Calibration Topics 2
S Is it acceptable to have an ASL for Critical suppliers alone? Supplier Quality Assurance and other Supplier Issues 4
S Is this Quality Policy acceptable in the context of ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 24
A Help with acceptable screw gage values per standard BS 919 for Go/ No Go gage General Measurement Device and Calibration Topics 4
S What are typical Acceptable Quality Levels (AQL) adopted in Food industry? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6
D Root Cause and Corrective Action - Is our Practice Acceptable? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Application of AQL (Acceptable Quality Level) Concept AQL - Acceptable Quality Level 15
H Acceptable Time to provide proof of CAR (Corrective Action Report) Nonconformance and Corrective Action 4
A Sample Size for Mathematical Model with acceptable Confidence Level Using Minitab Software 7
M AQL (Acceptable Quality Level) for Mixed Part Defect IATF 16949 - Automotive Quality Systems Standard 1
C Comparing Two Test Methods - Acceptable Difference(s)? Statistical Analysis Tools, Techniques and SPC 3
S AQL (Acceptable Quality Level) Report Form example wanted AQL - Acceptable Quality Level 1
M What is an acceptable PPM for large volume fasteners? APQP and PPAP 6

Similar threads

Top Bottom