Biological Monitoring Program Environmental Bioburden Test Method Needed

M

medguy123

#1
Hello,

We're a small device manufacturer needing to set up a biological monitoring program in our assembly area that we can perform ourselves. Can someone please recommend a simple (yet effective) method we can implement? Also, any details on required supplies/equipment to carry out would be much appreciated.

Thank you!
 
Elsmar Forum Sponsor
#2
Hello,

We're a small device manufacturer needing to set up a biological monitoring program in our assembly area that we can perform ourselves. Can someone please recommend a simple (yet effective) method we can implement? Also, any details on required supplies/equipment to carry out would be much appreciated.

Thank you!
I would suggest you to take a look at USP <1116> (United States Pharmacopeia)
 
Thread starter Similar threads Forum Replies Date
B Number of Biological Indicators for Routine Monitoring of ETO Sterilization Cycle Other Medical Device Regulations World-Wide 8
Doninina Biological evaluation procedure or plan EU Medical Device Regulations 3
M Biological testing at the end of the real time of MD Other Medical Device Related Standards 3
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 9
T Biological equivalency - Dermal filler EU Medical Device Regulations 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
B Biological evaluation plan and report Other Medical Device Related Standards 7
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
B Self Contained Biological Indicators as internal PCD Other Medical Device Related Standards 2
S IV Catheter Biological Evaluation - EtO Residuals - Permanent Contact Definition Qualification and Validation (including 21 CFR Part 11) 2
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
S Requirements of USP24 NF18 1995 for the Biological Test for Plastics Other Medical Device and Orthopedic Related Topics 3
M Biological Indicator Ethylene Oxide Sterilization Other Medical Device and Orthopedic Related Topics 11
D MDD 2007/ - Essential Requirement Checklist - Physical and Biological Properties EU Medical Device Regulations 4
I Glass Packaging Material (Jars) - Chemical, Physical and Biological Controls Manufacturing and Related Processes 1
T How to treat something (biological hazard) you know is there... Food Safety - ISO 22000, HACCP (21 CFR 120) 7
J Effects of substrate on biological indicator organisms US Food and Drug Administration (FDA) 2
I Certify the MD of remote monitoring according to the chronic pathologies EU Medical Device Regulations 0
K ISO 17025 Query Relating to Monitoring of Equipment ISO 17025 related Discussions 2
R UK Compliance monitoring (Auditing) of EASA/CAA Regulations 1321/2014 & 748/2012 EASA and JAA Aviation Standards and Requirements 0
eule del ayre Clause 7.1.5 Monitoring and measuring resources IATF 16949 - Automotive Quality Systems Standard 14
S Environment Monitoring System Validation ISO 14001:2015 Specific Discussions 1
armani Monitoring and measuring equipment for occupational health and safety purposes Occupational Health & Safety Management Standards 10
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
Quality Runner Continuous monitoring of validated process – sample sizes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Moncia Customer satisfaction monitoring - ISO 9001 and 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
J Revamping Supplier Qualification, Re-evaluation, and Monitoring Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
T EN 17141 - number of monitoring locations Other Medical Device Related Standards 2
Q 8.4.2.4 supplier monitoring IATF 16949 - Automotive Quality Systems Standard 3
Q IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Sub-contractor cleanroom monitoring ISO 13485:2016 - Medical Device Quality Management Systems 0
B Bioburden Monitoring ISO 13485:2016 - Medical Device Quality Management Systems 3
B Routine Bioburden Monitoring ISO 13485:2016 - Medical Device Quality Management Systems 5
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
I Calibrating the monitoring device but not the unit General Measurement Device and Calibration Topics 7
J Register of the monitoring and measuring equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Cleanroom Differential Pressure Monitoring, frequent manual observation US Food and Drug Administration (FDA) 6
J Need a contract monitoring Tool General Information Resources 0
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3

Similar threads

Top Bottom