Package Validation Testing & Accelerated Aging Studies
Microtest offers a comprehensive portfolio of package validation testing and accelerated aging studies. Our services include:
Accelerated Aging Studies
Accelerated aging studies can be predictions of what will occur to the packaging or product during normal storage conditions. Studies are used to set preliminary shelf life dates (i.e. expiration dates). Shelf life is the period during which the product remains stable for its intended use. Our studies include:
- Standard chamber temperature:
- -70C, -20C, 25C 60% RH), (30C 65%RH), (35C 75% RH), (40C 75%RH), (50C 10-50% RH),( 55C 10-50%RH), (60C 10-50%RH)
- Custom studies available
- All chambers monitored by SCADA – a 24-hour temperature monitoring system that alerts Microtest personnel to out of tolerance conditions
- Backup storage guaranteed
- Post-stability/aging testing available
Package Validation/Flexible Package Testing
Before accelerated aging of the product or package begins, the integrity of the packaging should be determined. Our services include:
- ISO 11607 regimens
- Package integrity testing
- Burst test
- Dye ingress testing
- Seal integrity testing
Real-Time Aging Studies
Medical Devices are required to have expiration dates based on accelerated and then real-time data. Real-time aging studies are recommended by the FDA
- Side-by-side real-time aging studies conducted in conjunction with accelerated aging available
ISTA Ship Testing
The purpose of a ship test is to challenge the strength and robustness of the product and package when faced with transport hazards.
- ISTA 1A/2A: Follows ISTA guidelines
Q10 temperature coefficient
Seal Strength
Seal Integrity Tests
Sterile Barrier Systems
ASTM F88-05, “Standard Test Method for Seal Strength of Flexible Barrier Materials” (West Conshohocken, PA: ASTM International, 2005).
ASTM International F2096-01, “Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test).”
ASTM D4169 and International Safe Transit Association (ISTA) Preshipment tests
- Common laboratory tests used to simulate the forces inherent in the distribution and handling environment
ASTM D2240
- Durometer, Form, Fit, and Function.
USP Volume 32, Section 1079
Federal Register 74, FR: 48423
ASTM packaging tests
Gel Permeation Chromatography (GPC), and Gas Chromatograph/Mass Spectrometry (GC/MS) testing for Leachates
Thermodynamic Temperature Coefficient by Von’t Hof
Arrhenius Reaction Rate Theory
Burst, Creep, Creep to Fail, Peel, and Leak
USP Volume 32, Section 1079
Federal Register 74, FR: 48423
ASTM packaging tests
ICH stability issues
- Bacterial, fungal, and mycoplasma sterility testing (USP sterility and FDA mycoplasma test).
- Viral sterility test (FDA virus assay).
- Particulate test (USP).
- Cytotoxicity (USP).
- Container integrity testing (MBD immersion test).
- pH analysis.
- Buffering capacity (container) USP.
- Leachate testing (container) GC/MS analysis.
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