Using real time shelf life study as accelerated

#1
Hi,

I wasn't sure where I can find information to clarify whether we can use our RL study data as an accelerated study data if we change the storage conditions.

E.g., Product A was stored in room temperature for 6 months but we decided to lower the storage temperature. Can you use the real life data as accelerated by using Q10 so that it can be claimed as 12 months?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Hi,

I wasn't sure where I can find information to clarify whether we can use our RL study data as an accelerated study data if we change the storage conditions.

E.g., Product A was stored in room temperature for 6 months but we decided to lower the storage temperature. Can you use the real life data as accelerated by using Q10 so that it can be claimed as 12 months?
Theoretically, the Q10 model assumes that reaction rates double every 10C degrees change. However, it is an approximation, and the entire model relies on several assumptions that don't necessarily hold in your case. Did you look into that?
If you assume (or are confident) that the Q10 model is valid in your case, you might be able to apply it to any temperature difference "around" room temperature. Use the Arhenius equation and pop in the exact delta T, then compute.
BTW, what is your "room temperature"? Did you monitor it during the ageing?
There's also the question of what the new storage temperature is. If it's near 0C (or lower) there's likely to be some non-linearity which will undermine your calculations.
 
Thread starter Similar threads Forum Replies Date
S Pulling Data In Real Time From Excel using Minitab 15 Using Minitab Software 2
W Making Minitab support real time data acquistion using digital gages interface Using Minitab Software 4
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
P Comparing Two Test Variables Using Attribute Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
R Using Scrapped NC items for training Medical Device and FDA Regulations and Standards News 15
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
J Using MD on a flight EU Medical Device Regulations 9
K Using Google Drive/Docs ISO 13485:2016 - Medical Device Quality Management Systems 16
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
T Poisson regression using Minitab Statistical Analysis Tools, Techniques and SPC 3
T Using NICE for guidance during CER CE Marking (Conformité Européene) / CB Scheme 0
T Using Review articles from Pubmed for CER CE Marking (Conformité Européene) / CB Scheme 8
Tagin Using a meme generator to poke fun at quality Funny Stuff - Jokes and Humour 2
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
V MSA - Using a R&R study for a Tape Measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Using a Non Certified vendor Supplier Quality Assurance and other Supplier Issues 8
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 3
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
rerusk1 MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
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
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1

Similar threads

Top Bottom