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Sharp Packaging Solutions Allentown, PA USA

Opened in 2005, our Allentown site is our flagship facility and the newest of all our contract packaging plants. Operations here focus on high-tech and biotechnology solutions.

  • 270,000 sq. ft. of cGMP product packaging space
  • Automated storage & retrieval system warehouse (8,600 pallet capacity & temperature controlled)
  • Cold storage (2 – 8° C), 500 pallet capacity
  • 40 enclosed packaging suites (HEPA filtered & pressure controlled, all primary rooms designed for less than 30% relative humidity)
  • DEA schedule II drug vault
  • FDA, DEA, EMEA, ANVISA Inspected
  • ISO 13485 Certified (Medical), ISO 9001 Certified (Drug Packaging)

Contract Services

  • Blisters / Carded Blisters Packaging
  • Bottle Packaging
  • Pouches / Stick Packs
  • Thin Film Pouching (oral dissolvable & transdermal patches)
  • Flow Wrap Packaging
  • Vial & Syringe Labeling & Kitting
  • Biotech Pen Assembly
  • Customized Packaging
  • Compliance Packaging
  • Serialization & E-Pedigree Services
  • Medical Device Packaging
  • Cold Storage
  • Specialty Distribution
  • Physician Sampling Program
  • Child Resistant Packaging

 

Products Packaged

  • Solid oral dose (tablets, capsules)
  • Specialized drug delivery systems
  • Liquids
  • Creams
  • Powders
  • Ointments
  • Gels

Quality History

  • Food & Drug Administration Inspections (FDA)
    • PMA – Feb. 2013 (No 483 issued)
    • GMP – Jan. 2012 (No 483 issued)
    • GMP – Apr. 2011 (No 483 issued)
    • GMP – Jul. 2009 (No 483 issued)
    • GMP – May 2008 (No 483 issued)
    • GMP – Sep. 2006 (No 483 issued)
    • GMP – Dec. 2004 (No 483 issued)
    • GMP – Jun. 2004 (No 483 issued)
    • GMP – Dec. 2003 (No 483 issued)
  • Drug Enforcement Administration Inspections (DEA)
    • Aug. 2013 (Mfg./ Importer/ Distributor)
    • Sep. 2011 (Exporter)
    • Sep. 2010 (Mfg./ Importer/ Distributor)
    • Jun. 2008
    • May 2007
    • Dec. 2006
    • Oct. 2006
    • Jun. 2005
    • Dec. 2004
    • Dec. 2003
  • European Medicines Agency (EMEA)
    • GMP – Jul. 2012 (United Kingdom – Site Approved)
    • GMP – May 2011 (Germany – Site Approved)
    • GMP – Jun. 2008 (Germany – Site Approved)
    • GMP – Jan. 2006 (France – Site Approved)
  • ISO 13485:2003 (Medical Device) – Certified Feb. 2009
  • ISO 9001:2008 (Drug Packaging) – Certified Jul. 2009
  • National Health Surveillance Agency (ANVISA)
    • GMP – Jun. 2011 (Brazil – Site Approved)
  • Pennsylvania Department of Agriculture
    • Inspected Apr. 2012 (No Observations)
    • Inspected Apr. 2010 (No Observations)
Sharp Packaging Services
We are an international leader in contract packaging and supply chain services. We provide unique and often complex commercial and clinical packaging solutions to the pharmaceutical and biotechnology industry. We're committed to quality and strive to add value by offering a range of extra services.