SBS - The best value in QMS software

Bacteriostasis/Fungistasis Testing

mpfizer

Involved In Discussions
#1
Hi,

Is the B & F test same as sterility test ?

Is it used over and above normal sterility testing ?

What are the ISO standards or USP for B & F testing?

Thanks
michelle
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Michelle,

No, B&F testing is intended to determine whether or not the product has intrinsic antimicrobial properties that inhibit microbial growth, potentially introducing an undesired bias falsifying your sterility test. Test of sterility is a separate test. The related standard is ISO 11737-2:2019.

Hope this helps,
 

mpfizer

Involved In Discussions
#3
Michelle,

No, B&F testing is intended to determine whether or not the product has intrinsic antimicrobial properties that inhibit microbial growth, potentially introducing an undesired bias falsifying your sterility test. Test of sterility is a separate test. The related standard is ISO 11737-2:2019.

Hope this helps,
Thanks
We manufacture orthopedic implants made of steel , the lab where we get sterility test done says that B & F test is only done on implants with drug coatings ?? so we don't require to do the test ...........any idea if that is right ?

Thanks

michelle
 

chris1price

Trusted Information Resource
#4
I think your lab may not have complete knowledge of the subject. Bacteriostasis and Fungistasis should be considered whenever a sterility test is being performed, including device sterilisation processes. It has nothing to do with drug coatings
 

planB

Super Moderator
#5
Michelle,

concurring with chris: you may want to interprete the lab's note the following way: typically, steel is known to not to inhibit microbial growth, and drug coatings are sometimes known to have antimicrobial properties.

However, there are high chances that regulators will ask for objective evidence for the lab's educated guess. So I would recommend to not skip this fast and cheap test according to ISO 11737-1, section A.6.6:

Product being tested should be screened to determine if any inhibitory substances are released into the medium which can cause a false negative (see A.7). This is performed by the inoculation of low numbers of representative organisms into the medium containing a product as is carried out in the bacteriostasis/fungistasis test.
Hope this helps,
 

mpfizer

Involved In Discussions
#6
I think your lab may not have complete knowledge of the subject. Bacteriostasis and Fungistasis should be considered whenever a sterility test is being performed, including device sterilisation processes. It has nothing to do with drug coatings
Hi,

you mention "whenever a sterility test is being done " please clarify...do you mean every time a sterility test is done ( as per USP 71 ) after gamma sterilization for batch release or when the sterilization validation is done and tested as per ISO 11737?

Thanks

michelle
 

planB

Super Moderator
#7
Michelle,

bacteriostatic and fugistatic properties are typically determined by the materials used in your device . So you typically perform B&F testing during (initial) validation and again when you change something in your product that might have an impact on the initial B&F test results.

Note that within the framework of ISO 11137-1 you release product from routine gamma sterilization by verifying whether the delivered routine dose for the batch is in the specified range; You do not perform tests of sterility when you release routine product.

Hope this helps,
 
Thread starter Similar threads Forum Replies Date
D Sterility (bacteriostasis/fungistasis) Testing by Membrane Filtration validation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 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
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
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 When is Bioburden Testing Required? Other Medical Device Related Standards 4
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 3
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4

Similar threads

Top Bottom