How to perform validation for an epoxy curing station

W

wfong3

#1
#1
Hi All,

Need some advice on how to perform validation for an epoxy curing station. Basically what we do is to pour epoxy into one of our sub assembly and bake it in the oven for 10-12hours at 70 degree celcius. According to the engineer, the temperature is not critical because the epoxy can also cure at room temperature but it may take longer time. The problem is we have no way of testing whether the epoxy has cured thus we have to validate this process.

Thank you in advance for your help :D
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
W

wfong3

#2
#2
Attached is the datasheet for the epoxy that we are using. Actually i am thinking is validation necessary for this process? If not then how to justify that validation is not required?

Thank you!
 

Attachments

somashekar

somashekar

Staff member
Admin
#3
#3
wfong3 said:
Attached is the datasheet for the epoxy that we are using. Actually i am thinking is validation necessary for this process? If not then how to justify that validation is not required?

Thank you!
Click to expand...
There are variables suggested in the data sheet and you are going to pick the one that best suits your application. So we are talking about a simple validation, and this is not rocket science at all.
You will also consider the curing temperature taking into consideration the temperature capability of other materials involved in the system, like ex: the material of the case in which the casting is done.
One sure way is to test the hardness after curing (use details provided in the data sheet). You could do this on your product directly if possible., or cast a specimen for the hardness test.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#4
#4
wfong3 said:
Attached is the datasheet for the epoxy that we are using. Actually i am thinking is validation necessary for this process? If not then how to justify that validation is not required?

Thank you!
Click to expand...
Start off with a risk evaluation - what might happen if it doesn't properly cure? What would have happened if you didn't bake it at all?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V Is it required to perform Process Validation for food or dietary supplements? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
A Do we need to perform Qualification and Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Do we need to perform Analytical Method Validation upon Relocation? General Measurement Device and Calibration Topics 5
R Can a Distributor perform Packaging Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Design Validation - How to perform Design Validation? ISO 13485:2016 - Medical Device Quality Management Systems 1
T Outsourced Manufacturing - Do we or our manufacturer has to perform the validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 7
J Starting a Weibull Analysis: Source on how to perform Weibull Reliability Analysis - Predictions, Testing and Standards 2
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
E Input to ANOVA 1-WAY - How can I perform this analysis in minitab? Using Minitab Software 2
B AS9102 FAI & Lower Level Drawings - How should we perform the FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Perform a coating weight test within 3 hours of processing the parts Manufacturing and Related Processes 2
D How to ensure independence and authority necessary to perform QM tasks ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q How to perform Process Capability for true position Statistical Analysis Tools, Techniques and SPC 11
H Do you have to perform an full internal prior to IATF 16949 audit? IATF 16949 - Automotive Quality Systems Standard 21
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6
S When will notified bodies be ready to perform audit to the MDR? EU Medical Device Regulations 1
chris1price Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall? CE Marking (Conformité Européene) / CB Scheme 5
P Can CEO perform internal audit Internal Auditing 11
B How to perform a MSA - GRR (Gage R&R) A&R/ANOVA Vs GUM/VDA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W DCMA and AS9100C - Dedicating a week and 5 auditors to perform a AS9100C audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C How to perform Gauge R & R on Automated Test & Measurement Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
E How do you perform a GR&R for system software generated values? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
B Do I need to perform Gage R&R on a Digital Temperature & Humidity Gage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 18
G Plant Relocation - Is it necessary to perform FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
L Who can perform ISO 9001:2008 Internal Audit prior to our Registration Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Registrars offering to perform Second Party Audits - Have they failed their role? Registrars and Notified Bodies 112
M How to perform Chelex DNA Method Verification in the lab General Measurement Device and Calibration Topics 2
E Should companies that perform calibration services be ISO 17025 accredited? ISO 17025 related Discussions 13
R How do you perform verification of a NCR (Nonconformance)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Hiring an External Auditor to perform our AS9100 Compliance Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E How to perform Discrimination check for Dial Indicator? General Measurement Device and Calibration Topics 2
A Does ISO/TS 16949:2009 require us to perform Final/Pre-dispatch Inspection? IATF 16949 - Automotive Quality Systems Standard 5
N Example of how to perform a Visual Attribute Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
J How do you perform a S3 Stability Study for a Non-Replicable Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
K How to perform Verification for a Gage that is used in Destructive Testing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Looking for service provider to perform residual dirt test, GME7061 General Measurement Device and Calibration Topics 2
J Is MS Outlook a sufficient reminder to perform yearly supplier evaluations? Quality Manager and Management Related Issues 10
T How to perform an MSA on Cross Hatch Test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Is it necessary to perform Root Cause Analysis for each failed part? Problem Solving, Root Cause Fault and Failure Analysis 16

Similar threads

Top Bottom