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

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player64

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#1
#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
 
QMS for Medical Device Companies
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planB

planB

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#2
#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
 
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player64

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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
 
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