SBS - The Best Value in QMS software

When is Bioburden Testing Required?

#1
If we are manufacturing a medical device in a non-certified clean room that is sent out to be packaged in a cleanroom & sterilized does routine bioburden testing monitoring need to be done during manufacturing or can it be done during packaging or by the sterilizer? Do some sterilization validations contain bioburden testing and monitoring?
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
Not certain but there is a question before that answer. What method are you using to sterilize? Ethylene Oxide? Radiation? I think the method determines the standard to use.
 

indubioush

Quite Involved in Discussions
#5
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
 
Thread starter Similar threads Forum Replies Date
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
M Bioburden testing for Class 10000 (Grade C) clean room ISO 13485:2016 - Medical Device Quality Management Systems 1
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
M Bioburden Frequency (sterile MD) Other Medical Device Related Standards 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
T Mold Limits for Microbiology Testing Other Medical Device Related Standards 3
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Testing criteria - where to place Design and Development of Products and Processes 2
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11

Similar threads

Top Bottom