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Pharmaceutical Packaging Testing

Pharmaceutical Packaging is one of the important criteria of the Pharmaceutical Industry as it helps in controlling the degradation of the Drugs. Every Drug Manufacturing or the Pharmaceutical Companies have to Evaluate the Viability and Ruggedness of the Packaging Options for each Specific Drugs. The Containers or Containers Closure with any kind of Contamination can degrade the Quality of the Drug products. The Packaging of the Pharmaceutical Products needs to comply the Pharmacopeia Standards and the Test Protocols. Generally, the Packaging of the Drug for example, Containers of the Drug helps in retaining the Therapeutic efficacy of the Drug Product and therefore maintaining the Standard Quality of the Pharmaceutical Packaging is Mandatory for every Pharmaceutical Companies.

EFRAC Testing and Analysis Laboratory is Accredited with ISO/IEC 17025 (NABL) Standards providing Testing Services for Containers and Containers Closures and Pharmaceutical Packaging based on several Pharmacopeia Methods like USP, EP, BP, IP and JP Methods. At EFRAC, the Highly Experienced Lab Technicians has been also conducting Atomic Absorption with Hydride Generation with the required specifications of the Pharmaceutical Packaging.

Parameters

• Materials (PE / PVC / PET / PBT/ Polypropylene / Polycarbonate / Polystyrene)
• Non Volatile Residue
• Transparency
• Buffering Capacity of Extractant
• Extractable and Leachable
• Acidity and Alkalinity of Extractant
• Absorbance of Extractant
• Oxygen Transmission Rate (OTR)
• Water Vapour Transmission Rate (WVTR)
• Dart Impact Resistance

Instruments

• GC MS/MS • GC FID • ICP MS & ICPE OES • Transparency Tester • Drop Tester • FTIR • Humidity Controller • Auto Clave • OTR & WTVTR Apparatus • Vibration Leakage Tester • Karl Fisher Auto Titrator • Tensile Strength Tester • GSM Round Cutter • Tensile Tearing Machine • Bursting Strength Tester • Box Compression Tester • Dart Impact Tester (PDI-350) • Drop Tester (PDT-0134) • Leak Test Apparatus • Humidifier • Vernier Caliper • Glass Thermometer • Digital Electronic Balance • Micro meter

Methods

• USP-NF (U.S Pharmacopoeia National Formulary
• IP (Indian Pharmacopeia)
• EU (European Pharmacopeia)
• BP (British Pharmacopeia)
• JP (Japanese Pharmacopeia)
• IS (Indian Standards)
• American Society for Testing and Materials (ASTM)