Package Validation Testing
Package Validation Testing LSO Medical device manufacturers are called upon to obtain approval on each individual medical device package. According to the ISO 11607 standard, the manufacturer must ensure the product and package system conjoin to create a complete product which performs efficiently, safely, and effectively in the hands of the user. Package Validation Testing […]
MPT Services
ISTA Standard 3A
ISTA Standard 3A LSO General Simulation Performance Tests Test Procedure 3A is for packaged-products weighing 150 lb. (70 kg) or less, and is a general simulation test for individual packaged-products shipped through a parcel delivery system. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number […]
ISTA Standard 2A
ISTA Standard 2A LSO Partial Simulation Performance Tests ISTA 2A tests are for packaged-products 150 lb. (68 kg) or less, and are a combination of basic test elements from ISTA 1A (Non-Simulation Integrity Performance Testing) and advanced test elements from ISTA 3A (General Simulation Performance Testing). Procedure 2A simulates some actual transport hazards such as temperature and […]
ISTA Standard 1G
ISTA Standard 1G LSO Non-Simulation Integrity Performance Tests ISTA 1G is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product and package combination to withstand transport hazards. ISTA procedure 1G is similar to ISTA 1A. The primary difference is that the vibration method used for ISTA 1G is […]
ISTA Standard 1A
ISTA Standard 1A LSO Non-Simulation Integrity Performance Tests ISTA 1A is for packaged-products 150 lb. (68 kg) or less, and challenges the strength and robustness of the product and package combination to withstand transport hazards. Procedure 1A is useful particularly when used as a consistent benchmark over time. Many medical device manufacturers use ISTA Procedure […]
ISTA Standards
ISTA Standards LSO International Safe Transit Association (ISTA) is the author of test procedures that define how packages should perform to ensure protection of their contents. ISTA has created the industry’s testing standards and is trusted worldwide to inform global manufacturers how to survive the ever-changing hazards of a global transportation environment, as well as […]
ASTM-F2096
ASTM-F2096 LSO Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Leak Test) The Bubble Leak test, which follows the ASTM F2096 standard, is conducted by visually inspecting for bubble streams caused from a defect in the packaging/sterile barrier system – all while it is submerged under water and gently […]
ASTM-F88
ASTM-F88 LSO ASTM F88 Seal Strength Testing for Medical Device Packaging ASTM F88 / F88M is the industry-standard test method for measuring seal strength in flexible sterile barrier systems. It confirms the mechanical integrity of a package seal after manufacturing, sterilization, transit simulation, and shelf-life aging. Under ISO 11607, seal strength testing is a required […]
ASTM-F1886
ASTM-F1886 LSO Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can bring forth evidence of sterile package […]