SBS - The best value in QMS software

Simulated product for bioburden testing

RDSally

Starting to get Involved
#1
Hi all!

I'm looking for your help on defining a simulated product for bioburden testing of vd max 25 method as described in EN ISO 11137-2. Since the final product is very expensive consisting of several components, I'm trying to find a solution where the bioburden sample would be simpler, but still fulfill the criteria of the standard.

With the current proposed bioburden sample, all processes and materials and size are considered but the surface area is somewhat smaller. Do you think this would be an issue? Or, is there another suggestion for determining the bioburden for a complex device?

In a case, where a simulated product is used for initial bioburden determination, how is the biourden level tested later during production; with the actual product or with the simulated product?

Thank you already in advance for you input on this!
 
Elsmar Forum Sponsor
B

brianthermophilus

#3
If the product has a claim of sterility for part of the product, you could perform bioburden testing on that portion of the product only.

If this route isn't feasible, I would recommend the Sample Item Portion (SIP) that is detailed in ISO 11137-2.

To answer your last question, Bioburden levels shall be tested on the actual product manufactured under similar conditions. From there you can determine whether the bioburden is evenly distributed on the item. If it is, you can establish your SIP from portions of the device that represent each of the materials from which the product is made.
 
Thread starter Similar threads Forum Replies Date
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
R Medical Equipment in Simulated Animal Enclosures IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Calibrating Thermometer with Simulated Output Temperature from Fluke 5520A General Measurement Device and Calibration Topics 6
T Simulated Use Cardiac Catheter Test Fixture Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
8 Simulated Factory - Assistance in simulation of a factory with a view to improving it Lean in Manufacturing and Service Industries 3
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 1
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
P EU MDR Translation of Product Name EU Medical Device Regulations 1
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
S How long does it take to register a product with MHRA? UK Medical Device Regulations 4
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1

Similar threads

Top Bottom