1. Pharmaceutical Packaging Products - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory
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    Pharmaceutical Packaging Products

    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.

     

    PARAMETERS

    WET CHEMISTRY:
    • Acidity/ Alkalinity of extractant • Absorbance of extractant • Global Migration , Specific migration

    INSTRUMENT (ICP-MS):
    • Heavy Metals ( Total & Leachable)
    • Extractable and Leachable (different stimulant) Heavy Metals like Al, Pd, As, Cd, Co, Cr, Hg, Zn, Ni, Ti, V, Zr, Sb, Ge, Ba, Mn etc.

    INSTRUMENT (TOC Analyser):
    • TOC of extractant

    PHYSICAL:
    • Identification • Material • Ink adhesion test • Product Resistance

    INSTRUMENT (Transparency Tester):
    • Transparency

    DART IMPACT TESTER:
    • Dart Impact Resistance

    DEAD WEIGHT THICKNESS GAUGE:
    • Odour/Thickness/ Width of film

    BURSTING STRENGTH TESTER:
    • Bursting strength

    TENSILE TESTER:
    • Tensile Strength, Tensile elongation & Tensile index

    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)
    • Indian Standards (BIS)
    • U.S. Pharmacopoeia National Formulary (USP-NF)
    • European Pharmacopoeia (EP)
    • British Pharmacopoeia (BP)
    • Japanese Pharmacopoeia (JP)
    • International Organization for Standardization (ISO)
    • American Society for Testing and Materials (ASTM)