The Safety and Efficacy of all Pharmaceutical Products are inextricably linked to their packaging. Containers or Container Closures that do not meet the Physical, Chemical, or Biological Specifications of Major Compendia will compromise the Quality of the Drug Product itself. EFRAC’s Container Testing Services help ensure the Quality and Protection of Drug Products. The Packaging System used to deliver Pharmaceuticals to patients is a crucial part of New Product Development. Containers must be capable of retaining the Therapeutic Efficacy of the Drug Product from the moment it is packed through to their Administration. Containers that do not meet the Specifications of the Major Compendia can compromise the Safety and Effectiveness of the Drug Product.
EFRAC performs testing on virtually all container types requiring evaluation, including plastic bottles, glass vials, stoppers and raw plastic (resin pellets, sheets, etc.). We provide professional testing services for containers, container closures and pharmaceutical packaging on a broad range of polymer containers to several pharmacopeia methods, including USP, EP, BP, IP and JP methods.
EFRAC also offers Atomic Absorption Spectrometry with Hydride Generation to support Full EP Monograph Requirements. The Extractable and Leachable Analysis examines the potential for the Migration of Chemicals from Container Closures into the product and demonstrates that the Package being tested meets the requisite specifications. EFRAC’s Pharmaceutical Container and Packaging Testing Service is supported by state-of-the-art Laboratory Equipment, including a fully-validated Autoclave System enabling accurate results to be made available to Clients.
PARAMETERSWET CHEMISTRY: INSTRUMENT (ICP-MS): INSTRUMENT (TOC Analyser): PHYSICAL: INSTRUMENT (Transparency Tester): DART IMPACT TESTER: DEAD WEIGHT THICKNESS GAUGE: BURSTING STRENGTH TESTER: TENSILE TESTER: |
OTHER PARAMETERS• Non Volatile Residue • Controlled Extraction Studies • Total Terephthaloyl Moieties, and Ethylene Glycol of extractant • Colorant Extraction • Residual pigments & colorants • Residual additives • Water Vapour Transmission Rate (WVTR) • Non volatile residue & residue on ignition • Buffering capacity of extractant • Oxygen Transmission Rate (OTR) INSTRUMENTS• FTIR • DSC • GC MS/ MS • GC-FID • LC-MS • ICP-MS & ICP-OES • Ion Chromatogram • Karl Fischer Auto Titrator • Transparency Tester • Drop Tester • Hot Air Oven • Vibration Leakage Tester • Humidity Controller • Analytical Balance • Vernier Caliper • Digital Screw Gauge • Autoclave • OTR & WTVTR apparatus STANDARDS / REGULATIONS• Indian Pharmacopoeia (IP) |