Pace Analytical Services, LLC
- Service Details
AMRI's cGMP, FDA-registered and ISO 17025-accredited laboratories provide integrated services for primary container and packaging performance testing for the world’s leading pharmaceutical and biotech manufacturers.
- Service Details
Following an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate.
- Service Details
Pace Analytical Life Sciences (PLS) is a full-service contract testing laboratory providing physical and functional testing services to the pharmaceutical and medical device industries.
Complete suite of testing services is provided by the analytical services provider which include pharmaceutical package testing. Drug product packaging must be able to withstand the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity and protects the primary product. Our services help your life-saving therapies reach the patient in usable form. Medical Device Package Testing: Per ISO 11607 standards, medical device manufacturers are required to ensure the integrity of their sterile medical device packaging. Medical device package validation includes package stability testing, performance/dynamics testing and strength and integrity testing following the guidelines of ISO 11607. Consumer Product Package Testing: Distribution testing of packaging designs per ISTA and ASTM methods to eliminate the problem of damaged goods and lost business before they happen. Services simulate the conditions that consumer products experience throughout the distribution cycle: vibrations, stacking, dropping, baking or freezing. Drug product packaging must be capable of withstanding the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity, protects the primary product, preserves critical labeling and patient information and can easily be administered by the end-user. Analytical labs assist clients to better understand the testing requirements and the available test options from simple over-the-counter (OTC) products and topical creams to prescription drugs such as tablets, capsules and liquids to sophisticated drug delivery devices. Selection and validation of appropriate packaging for OTC, biologics and pharmaceuticals. Routine pharmaceutical packaging testing services are Distribution Simulation: Distribution simulation services in accordance with the most current test methods from ASTM and ISTA (International Safe Transit Association) such as ASTM D4169, ASTM D7386 and ISTA 1, 2, 3 and 4 Series Tests. Laboratory distribution simulation testing provides a uniform and repeatable way of evaluating drug product packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products. Container Testing: Comprehensive qualification testing for all primary container components – plastics, glass and elastomeric closures. Testing required for regulatory compliance to USP, EP and JP standards for Container Permeation Testing, Material Identification Testing, Extractable Testing and Functionality Testing. Container Closure Integrity Testing: Container Integrity Testing laboratory offers numerous state- of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. Container Closure Integrity test programs have been successfully used to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world. Shelf Life Testing: Product storage programs that help ensure product safety throughout the product’s shelf life. Accelerated Aging (AA), Real Time Aging, Freeze/Thaw and full ICH Stability programs etc. come under this category. Visual Inspection and Functional Testing: Inspection services for container / product defects, routine QC dimensional testing and essential performance / functionality testing for prefilled syringes and other drug delivery devices. Packaging Materials Barrier Properties: Tests to characterize adsorption, dissolution, diffusion, and desorption of packaging materials, including Oxygen Transmission Rate or OTR via ASTM D3985 or ISO 15105-2 and Water Vapor Transmission Rate or WVTR via USP <671>, ASTM F1249, D7709, ISO 15106-2 and ASTM E96, These barrier properties tests help plan the optimal packaging material choice for specific applications to maximize preservation and prolong the shelf life of the product. cGMP and ISO 17025 accredited services that cover the complete package system from package development to market.
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