Average Peel Strength - Interpretation of BS EN 868-5:2018 and ASTM F0088/F0088M

#1
Hi Friends,
I am a process validation engineer in a medical device manufacturing company and we are in the process of validating the Tyvek pouch peel strength requirements in accordance with the revised standard BS EN 868-5:2018.

Here are the key guidelines from the relevant stndards:
  1. BS EN 868-5:2018 states that:
  1. Follow ASTM F88/F88M.
  2. Record the average force over the middle of measured profile by discarding 10% on each side of curve.
  1. ASTM F88/88M states that:
  1. The initial ramp-up from zero to the force required to peel is not indicative of seal strength so it should not be included in the calculation of average strength.
  2. The amount of data discarded on each end must be same for all tests within any set of comparisons of average seal strength.
  3. Section 9.8.1 – Follow machine manufacturer’s instructions to select the desired algorithm.
My question is .....
the instructions in 1b and 2a are contradictory as they both cannot be met.

Please help me understand the interpretation / intent of this requirement.

At the same time is it possible to access the documents which will explain the intent behind this requirement...discussions which the technical committee had while finalising this requirement.

Thanks in advance,

Player64
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
Player64,

the intention of both guidance documents is that you measure the "plateau phase" (with all its method-instrinsic ups&downs/variations during this phase) during the peeling experiment, without including potential artefacts at the beginning and end of the peel phase.

Typically, technical committee documents are purely internal and are not publicly shared. You could contact technical committe members directly: in my experience they are quite open to interpretation questions.

HTH,

Gerhard
 
#3
Thanks Gerhard,
that clarifies it and will help me to convince my friends in QA and RA.
I have never done it in the past but would still like to connect with one of the technical committee members to experience their response.

Thanks
Player64
 
Thread starter Similar threads Forum Replies Date
Q Best approach to get a real value as average? Statistical Analysis Tools, Techniques and SPC 6
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Average and standard deviation of Cumulative Data Statistical Analysis Tools, Techniques and SPC 5
F Calibration certificate content - Average Value and True Value ISO 17025 related Discussions 6
P Average access height into an industrial machine (average base plate height) Human Factors and Ergonomics in Engineering 2
Q Cycle times, value stream mapping, inventory, average values? Lean in Manufacturing and Service Industries 1
Proud Liberal How long does your company take to close an 8D on average? Problem Solving, Root Cause Fault and Failure Analysis 12
L How to interpret the average R bar Value shown in the R Chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M Cp & Cpk about a diameter measured with min.,max. and average values. Capability, Accuracy and Stability - Processes, Machines, etc. 13
J0anne GCC Submissions - Average review time for SGH qualification files Other Medical Device Regulations World-Wide 10
K Average height of adults by sex by state Other Medical Device and Orthopedic Related Topics 10
M What is the difference between X Bar - R Charts and Average Chart? Statistical Analysis Tools, Techniques and SPC 7
M Average Run Length (Student Question) Statistical Analysis Tools, Techniques and SPC 3
F Statistical Comparison of Product: High Average vs. Low Range Capability, Accuracy and Stability - Processes, Machines, etc. 13
G Improve final GR&R value by taking average of more measurements? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Can I do an average measurement values for a sample? Statistical Analysis Tools, Techniques and SPC 1
M MSA 4 - Results of GR&R Study using Range & Average Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
T Counting the Average Times of Alarms in a Process using Minitab Using Minitab Software 5
Q How to determine the average baseline for the following data in SPC Quality Tools, Improvement and Analysis 3
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
T Bias & Linearity Study - How to calculate the P value for the Average Bias Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
G Product Returns are above average for Labeling Problems Quality Manager and Management Related Issues 4
R GR&R (Gage R&R) - Average Range Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
B XbarR or EMWA (Expontionally Weighted Moving Average) or MA Chart - Which to Use Statistical Analysis Tools, Techniques and SPC 6
R What is the Sigma Level of the Average Company? Six Sigma 11
Stijloor Toyota drags down new-vehicle quality average World News 9
P ISO 27001 Controls - Industry average % IEC 27001 - Information Security Management Systems (ISMS) 3
Stijloor The ARMA (Autoregressive Moving Average) Chart Statistical Analysis Tools, Techniques and SPC 6
D Influence of the Coverage Factor - Worksheets based on the Average and Range Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
B To IMR or Moving Average chart now that's the question! Statistical Analysis Tools, Techniques and SPC 11
M Inferences from Distribution? (Average per hour/the average pay of the staff) Six Sigma 2
O Average Life Cycle Duration for a large number of medical equipment types Other Medical Device and Orthopedic Related Topics 2
Randy US Average Hourly Employee Cost Career and Occupation Discussions 3
K Calculating Control Limits in Average and Range Charts Statistical Analysis Tools, Techniques and SPC 3
C What does the average employee need to know about the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
B Control Chart - Minimum point & average insulation thickness for Automotive Wires Statistical Analysis Tools, Techniques and SPC 9
DanteCaspian 5S Workplace Average for those that score 5 S Lean in Manufacturing and Service Industries 5
T Monitoring a shift of the average in an SPC chart Statistical Analysis Tools, Techniques and SPC 11
T What is Average Run Length & Average Production Length when used in Control Charts? Statistical Analysis Tools, Techniques and SPC 4
C Is Parts/Process Average Testing SPC by Another Name? Statistical Analysis Tools, Techniques and SPC 3
D Average fill label - "e" Mark, probably a UK specific requirement. Manufacturing and Related Processes 8
D Queuing System - Calculating Average Arrival Rate λ Statistical Analysis Tools, Techniques and SPC 3
W Advice on the best way to approach a double moving average using Minitab 15 Using Minitab Software 3
K Average Salary for Quality Personnel? Career and Occupation Discussions 12
E Moving Range Average Calculation in Excel (in a single cell only). Excel .xls Spreadsheet Templates and Tools 9
S Average Cost of ISO 13485 Registration in US ISO 13485:2016 - Medical Device Quality Management Systems 10
D How to Measure a Diameter - Average or Maximum/Minimum? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 25
D When to Create a New Baseline Average for a Process Statistical Analysis Tools, Techniques and SPC 2
D Stable process but the average baseline is unacceptable Statistical Analysis Tools, Techniques and SPC 8
N Average range of measurement system NDC number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Similar threads


















































Top Bottom