Bioburden testing for Class 10000 (Grade C) clean room

mpfizer

Involved In Discussions
#1
we have a class 10k grade c clean room, what is the standard applicable for microbiological testing for bacteria and fungi . and where the settle plates should be placed and how many ?? there is a standard for particle count but i am not finding a standard for bacterial and fungal count testing and how alert and action limits should be fixed..Is there a relation between the size of room and number of locations to test?

Thanks

michelle
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
F Bioburden Testing requirements for Non-Sterile Dental Products EU Medical Device Regulations 6
R Simulated product for bioburden testing Other ISO and International Standards and European Regulations 2
O Bioburden Testing - Non Sterile Product / Tapes - ISO 11737-1 Other ISO and International Standards and European Regulations 9
P Serial Testing of Bioburden for Medical Devices Other Medical Device Related Standards 2
P Frequency of Bioburden Testing EU Medical Device Regulations 3
M Sterility Testing vs Bioburden Testing - Differences Qualification and Validation (including 21 CFR Part 11) 7
I Bioburden and Endotoxin (LAL) Testing proposal help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C ISO 11737 - Bioburden testing for non-sterile products Other ISO and International Standards and European Regulations 10
I Microbiological Testing - Bioburden and Identification of Micro-Organisms ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
V Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices Other Medical Device Regulations World-Wide 7
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
M Bioburden numbers and ECA gloves 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Biological Monitoring Program Environmental Bioburden Test Method Needed ISO 13485:2016 - Medical Device Quality Management Systems 1
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
B BioBurden and EndoToxin Questions Other Medical Device Related Standards 6
S Bioburden Monitoring Sample Size Increase ISO 13485:2016 - Medical Device Quality Management Systems 4
I Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Bioburden Monitoring - 'Off the Shelf' Bioburden/Microbiological Monitoring Software ISO 13485:2016 - Medical Device Quality Management Systems 4
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
0 Guideline/Method for Raw Material Roll Stock Bioburden Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q Bioburden Requirements on Device used on Unbroken Skin Other Medical Device and Orthopedic Related Topics 4
A Microbial Limit (Bioburden)on dry nonwoven that used for making Hand sanitizing wipes ISO 13485:2016 - Medical Device Quality Management Systems 1
D Bioburden and Product Labels - VD Max studies on all the BOMs Other Medical Device and Orthopedic Related Topics 9
H Determining a New Product Bioburden Limit ISO 13485:2016 - Medical Device Quality Management Systems 11
L Validation of transfer materials - Bioburden of items from lab into cleanroom Other Medical Device and Orthopedic Related Topics 2
L Monitoring bioburden on clean room gloves Other Medical Device and Orthopedic Related Topics 1
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
E Bioburden tests duration and Monitoring of gloves ISO 13485:2016 - Medical Device Quality Management Systems 6
S What is a reasonable Bioburden limit? ISO 13485:2016 - Medical Device Quality Management Systems 13
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
P Testing cloud-based backups IT (Information Technology) Service Management 7
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5

Similar threads

Top Bottom