What is an acceptable bioburden level or count when working in cleanroom ISO class7

C

chandr

#1
Hi all

I'm new to all of this and find this forum very helpful, although I do apologize as I'm not sure how to set up a new thread or create my own discussion.

Here is my question: How do you determine what is an acceptable bioburden level or count when working in a cleanroom ISO class 7 manufacturing medical devices. This is not referring to the product bioburden but rather the environmental bioburden?
Is it necessary to use swabs as well as air plates? We work with ISO 13485.

I would really appreciate it if someone could help me. I have searched everywhere for answers but struggle to find one.

Thank you
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: what is an acceptable bioburden level or count when working in cleanroom ISO clas

Welcome here chandre ...
I have moved your 1st post into a new thread for more better responses.
You can do a lot of things yourself now that you are a registered member. Read through These Threads
 
Last edited:
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
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
K How do you determine what is acceptable base on an FMEA RPN FMEA and Control Plans 6

Similar threads

Top Bottom