About the Author
by Charlie Webb | Nov 7, 2016 | Sterile medical device packaging, Uncategorized | 0 comments
As the quality manager for our ISO-17025 laboratory it is become native for me to evaluate machine purchases through a global and perhaps a more cynical vista. With medical device packaging machinery, you need to consider a multitude of factors. How easily will I be...
Please carefully read and agree to the test methods that we utilize for medical pouch testing. It is important to remember that we do not interpret the data as to its value to your process as this function should be determined by your quality team against your packaging validation plan. Again it is vital that you read and understand the limits of our medical pouch study and to make sure that our procedures meet your regulatory and internal quality requirements. Please note that these factors may not all be applicable to your particular material.
We only provide raw data to be analyzed by your quality team
Any special requirements must be in writing on our submission form
We cannot perform any test procedures that falls outside our scope of accreditation
We do not perform statistical analysis of your study
We do not perform DOE’s (design of experiments)
1. Ensure that the number of samples that you are sending is sufficient to perform the tests. Remember that some of the material may be sacrificed during the process of determining the upper and lower limits of the material.
2. For every different type of material, or different size of pouch, an individual form must be filled out with the required information so that the test report can be completed properly.
3. Our test method is the following method as stated in the ASTM F88/F88M-15:
4.2.1 Technique A: Unsupported — Each tail of the specimen is secured in opposing grips and the seal remains unsupported while the test is being conducted.
4. Seal your pouch samples or gather samples from production that you wish to have evaluated. Be sure to note the sealing machines serial number that created the samples. If you require pouch normalization periods longer than our standard 48 hours, please indicate your normalization dwell preferences.
5. Provide us with adequate seal samples (35 for our standard test program) as well as additional buffer samples. If you are sending samples sealed at various times and temperatures settings, please mark specimens individually to thwart confusion. Please indicate any special conditions on this form.
6. Be sure to read our peel study SOP and disclaimer to be certain that our testing methodologies are in sync with your regulatory and internal requirements. Send in sturdy box to our Laboratory.
Scope: In accordance with section one of the ASTM F88/F88M:
This test method covers the measurement of seal strength in flexible barrier material, in this case medical device pouches (F88 1.1). This test method measures the force required to separate one side of a fin type seal from the other and also identifies the method of seal failure (F88 1.4).
Significance and Use: In accordance with section four of the ASTM F88/F88M:
The measurement of seal strength is important not only in determining opening force but also determining the ability of the process to produce consistent seals (F88 4.1). While measuring the opening force is important there are times when the force may need to be lessened to facilitate opening (F88 4.1). Besides maximum force the average force to open the seal may be useful for some applications and in those cases should be reported (F88 4.1.1). Because some of the force measured may be caused by other influences beside seal strength it is important to use only one technique throughout a set of tests (F88 4.2). We have standardized our usage to the following: Technique A: Unsupported—Each tail of the specimen is secured in opposing grips and the seal remains unsupported while the test is being conducted (F88 4.2.1).
Apparatus: In accordance with section six of the ASTM F88/F88M:
We use a PTT-100V test unit that has a system for measuring the force required to separate the sample and the rate of jaw separation, these systems are accurate to +/-2% (F88 6.1) This sealer utilizes a constant rate of separation that is adjustable from 200 – 300 mm/min and has lever action grooved jaws to prevent slippage of the specimen during testing (F88 6.1).
We use either an SPC-1 or SPC-2 specimen cutter to create a sample with a size of 1.00 in. [25.4 mm] in width within a tolerance of +/-0.5 % (F88 6.2, Test Methods D882: 5.4).
Sampling:
In accordance with section seven of the ASTM F88/F88M the sample population should be of sufficient size to determine overall performance of the seal and sealing system (F88 7.1). Indiscriminate removal of samples with defects may bias the results and should be considered carefully depending on the purpose of the investigation (F88 7.2).
Aging and Conditioning:
In accordance with section eight of the ASTM F88/F88M a minimum of forty hours shall be allowed for conditioning of any samples received, unless otherwise requested by the customer or if other information shows that seal strength stability is reached in a shorter time (F88 8.1, 8.2). The conditioning period may be shortened if necessary to meet certain test objectives, such as the testing of seal strength after a specific period of storage (F88 8.3).
Procedure: In accordance with section nine of the ASTM F88/F88M:
The test unit is calibrated per the manufacturer’s specification (F88 9.1). The specimens are cut to size following the guidelines in section 9.2, making allowances where it is permitted due to smaller grip separation (F88 9.2). Ensuring that only Technique A: Unsupported is used to minimize variance, each leg of the specimen is fixed into the grips with the sealed area being placed an equal distance between the grips (F88 9.3). Center the specimen in the grips, aligned so the seal line is perpendicular to the direction of pull, making sure no stress is put on the specimen prior to the test (F88 9.4). Please note on the test report the orientation of the fin seal as a significant difference has been measured based upon orientation (F88 9.5) If the specimen peels apart in the seal area, either by adhesive failure, cohesive failure, or delamination, the average peel force is measured by the testing machine as a part of the test cycle (F88 9.8, 9.8.1). If the specimen does not peel significantly in the seal area and failure is largely by breaking, tearing, or elongation of the substrate material, average force to failure may have little significance in describing seal performance (F88 9.8.2).
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