Package Testing and Validation Services A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary package must maintain its sterile barrier properties for this period of time. It must be able to maintain its seal strength and package integrity under the stress of production, sterilization, distribution and handling, and after aging for the shelf-life claimed.
AppTec’s experts can help you plan a package testing program that will meet your needs and the applicable regulatory requirements. A package validation program (per ANSI / AAMI / ISO 11607)
would include such services as: Protocol, Sealer Performance Verification, Product Qualification
(3 lots), Simulated Shipping Qualification, Shelf Life Studies (Aging) and Summary Report(s).
NOTE: Package testing samples should be sent directly to AppTec’s Camden facility. In this section
The test methods described in this section provide a comprehensive
means of establishing that package integrity is compliant with
International Standard ISO 11607,
"Packaging for Terminally Sterilized Medical Devices." |
| Seal Integrity Testing Back to Top |
Regulations dictate that the seal strength and specification limits be determined for pre-sterilization sealer performance verification (high, low & standard parameter settings) and seal strength consistency qualified for post-sterilization production, shipping and shelf-life qualifications.
| 38030 | This method will determine the strength of a specific area of the seal for a medical device package. It may be used for pouch or tray/lid type packages having two components joined by an adhesive or heat seal process. The method does not measure seal continuity. Its most common application is for establishing process control parameters, package performance specifications and support package validation. A 1-inch wide seal strip is obtained from each side of the package (e.g., 4 samples). The seal is pulled apart using a tensile-testing apparatus. The peak force required to completely separate the two components is recorded.
SAMPLE REQUIREMENTS
10 (minimum) primary packages per process variable |
Seal Tensile Strength
[ASTM F 88] |
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| 38039 | This method is used to determine a package’s ability to resist internal pressure and is a measure of the strength of the package seals. Its most common application is for establishing process control parameters, package performance specifications, and support package validation. SAMPLE REQUIREMENTS
10 (minimum) primary packages per process variable | Burst Strength
[ASTM F 1140]
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 38040
Creep Strength
[ASTM F 1140] |
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| 38061 | This method is specifically for pressure sensitive tapes but has been used as a basis for performing a peel adhesion or seal uniformity measurement for medical device packages. The methodology may be used to determine the maximum and continuous force required to peel a pouch open or a lid from a tray over some predetermined seal distance. SAMPLE REQUIREMENTS
10 (minimum) primary packages per process variable | Peel (Seal) Adhesion Strength
[ASTM D 3330] |
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| Package Integrity Testing Back to Top |
Regulations dictate that the integrity of sterile packages be maintained during the production, shipping and shelf-life of the product. Physical testing for package leaks has been shown to be more sensitive than the microbial challenge test, and is the generally preferred method.
| 38033 | This method, which covers the determination of gross leaks in flexible packaging, is applicable to nonporous packages and to test porous packagings which have their porous component sealed using polycrylic solution. It is used to detect leakage of air through a channel in the seal or pin-hole in the package. The test is performed by submerging the package underwater and observing for leaks. This provides attribute data on the integrity of the primary package directly after production or after experiencing a dynamic or environmental related event. SAMPLE REQUIREMENTS
30 primary packages recommended |
Bubble Emission Test
[FPA/SPMC 005-98] |
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| 38038 | This method, which covers the determination of gross leaks in flexible packaging, is applicable to porous and nonporous medical device packages. It is used to detect small leaks in materials or seals of packages where harmful biological or particulate contamination may enter. The method may be used to detect holes in package materials or channels in seals as small as 0.0025 inches. This provides attribute data on the integrity of the primary package directly after production or after experiencing a dynamic or environmental related event. SAMPLE REQUIREMENTS
30 primary packages recommended |
Dye Penetration
[ASTM F 1929] |
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| 38062 | This method covers the testing of empty containers for resistance to leakage under differential pressure conditions such as those which can occur during air tranport. It may be suitable for testing pharmaceutical containers without modification to closures or body. SAMPLE REQUIREMENTS
30 (minimum) primary packages per process variable | Leak Test by Vacuum
[ASTM D 4991] |
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| 38051 | This method is used to evaluate the ability of an intact, production package to maintain its sterile environment until it reaches its point of end use. The procedure includes preliminary test validation with the subject package, followed by an aerosol or talc challenge in the test chamber, package exterior decontamination, and subsequent sterility testing to determine the presence of the indicator organism inside the package or on the product. The aerosol may be performed under static or dynamic conditions. Dual-barrier packages may have one or both barriers validated for sterility. SAMPLE REQUIREMENTS
12 primary packages recommended
(10 test, 1 positive control, 1 negative control) | Whole Package Microbial Aerosol Challenge with
Sterility Test
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 38059
Whole Package Microbial Talc Challenge with Sterility Test |
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| 38060 | This method is used to assess the ability of a non-porous package to provide a microbial barrier. Packages containing sterile growth medium are immersed in a buffer solution containing a known concentration of an indicator organism. After the challenge, the packages are dried under laminar flow, then incubated and inspected for growth of the indicator organism. The method may be used for foil-lidded trays, foil pouches, and rigid containers with closures. SAMPLE REQUIREMENTS
30 packages recommended |
Microbial Ingress / Immersion Challenge |
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| Transportation/Distribution Simulation Testing Back to Top |
| Manufacturers must evaluate the package’s and shipper’s ability to adequately protect the product through the handling, shipping and distribution environment. Damage such as puncture, abrasion and seal failure may result. NOTE: The ASTM procedure is the method of choice as it provides a more realistic simulation of the distribution environment and uses test levels which are more indicative of actual occurrences. |
| 38052 | This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (e.g., shock, drop, vibration, compression) which are encountered in various distribution environments. The test plan provides a uniform basis of evaluating, in a controlled and repeatable laboratory environment, the ability of the shipping units and contents to withstand the distribution environment. The test plan uses established test methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13, Assurance Level I, which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined. SAMPLE REQUIREMENTS
One or more shippers
(to provide 40 units for seal and package integrity tests) |
Distribution Simulation
Shipper Test
[ASTM D 4169 - DC 13] |
|
| 38057 | These tests provide a means for a manufacturer to predetermine the probability of the safe arrival of their packaged-products at their destination through the utilization of tests developed to simulate the shocks and stresses normally encountered during handling and transportation. SAMPLE REQUIREMENTS
One or more shippers
(to provide 40 units for seal and package integrity tests) |
Shipper Simulation Test
[ISTA Project 1A] |
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| 30659 | Temperature Cycling Sequence
1. Frozen or winter ambient
-29°C for 72 hours, no RH control
2. Tropical wet then dry
38°C @ 85% RH for 72 hours, then 60°C @ 30% RH for 6 hours
SAMPLE REQUIREMENTS
Varies |
ISTA Environmental
Conditioning
[ISTA Project 2A] |
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| 30660 | Temperature Cycling Sequence
1. 50°C/20% RH, 30 minute transfer, 30 minute dwell
2. -40°C, 30 minute transfer, 30 minute dwell
3. Repeat steps 1 and 2 five times
4. 50°C/20% RH, 30 minute transfer, 24 hour dwell
5. 40°C/80% RH, 30 minute transfer, 24 hour dwell
6. -40°C, 30 minute transfer, 24 hour dwell
SAMPLE REQUIREMENTS
Varies |
ASTM Environmental Conditioning
[ASTM 810 E] |
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| 38053 | Temperature Cycling Sequence
10 Cycles of the following:
1. -55°C for 30 minutes
2. Room temperature for 5 minutes
3. 85°C for 30 minutes
4. Room temperature for 5 minutes
SAMPLE REQUIREMENTS
Varies |
Thermal Shock
[Mil Std 202-F, Method 107G] |
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| Accelerated Aging/Shelf-Life Studies Back to Top |
Some domestic regulations and all international directives require expiration dating on sterile medical device packages. The package integrity and maintenance of a sterile barrier must be supported by documented test data after accelerated and/or real-time aging for the shelf-life claimed. Environmental factors such as exposure to low and high humidity as well as freezing conditions are also considerations. ACCELERATED AGING TESTING (ASTM F 1980) Information required: •Volume of Material •Expiration Date
•Test Temperature •Ambient (Storage) Temperature
•Aging Factor (Q10) [The most common Q10 is 2.0]
Von't Hoff Theory of Q10 - Sample Calculation
Accelerated Aging Rate (AAR) = Q10 ((elevated temp. – ambient temp)/10)
Where: Q10 = 2.0 Ambient Temp. = 22°C Test Temp. = 55°C
Real-Time Equivalent (RTE) = Desired Real Time Aging
AAR
So... AAR = 2 ((55-22)/10) AAR = 9.85 1 year RTE = 365/9.85 = 38 days |
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| 38034 | Condition primary packages at a test temperature of 55°C for a period of 1 year of equivalent real time aging. This test may include exposure to high humidity and low humidity plus 2 days of freezing conditions to provide maximum stress to packages. Ambient storage temperature = 22°C.
TEST DURATION 40 days = 1 year RTE | Accelerated Aging
@55°C/1 year |
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| 38058 | Condition primary packages at a test temperature of 37°C for a period of 1 year of equivalent real time aging. Ambient storage temperature = 8°C. TEST DURATION 49 days = 1 year RTE | Accelerated Aging
@37°C/1 year |
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| 38036 | Condition primary packages at a test temperature of 60°C for a period of 1 year of equivalent real time aging. This test may include exposure to high humidity and low humidity plus 2 days of freezing conditions to provide maximum stress to packages. Ambient storage temperature = 22°C. TEST DURATION 29 days = 1 year RTE | Accelerated Aging
@60°C/1 year |
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| 38037 | Condition primary packages at a custom test temperature for an equivalent real time aging period to be determined. Environmental factors may be considered. TEST DURATION Use equation above to determine RTE. | Accelerated Aging -
Custom |
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