Short Term Storage of Finished Drug Substances

 

Project Scope:

  • Secure short term storage for three one pallet shipments of finished drug substance in drums at-22.5ºC +/- 2.5ºC
  • Environmental and security monitoring, data recording and redundancies required by GMP standards

Personnel:

  • 1 Product Monitoring Technician
  • 2 Shipping / Receiving Technicians
  • 1 Quality Review Specialist
  • 2 Administrative Assistants

Equipment:

  • Energy Efficient -22.5°C walk In

Results:

  • Samples were successfully stored and monitored
  • Enabled customer to service their client

Project Summary:

Masy BioServices effciently provided short term storage for three one pallet shipments of material in drums at -22.5ºC +/- 2.5ºC. This storage included all environmental and security monitoring, data recording and redundancies required by GMP standards. Each Pallet was stored at Masy for approximately 4 weeks and had 1 to 3 drums on them that could not be removed per customer request.

Masy maintained cGMP standards and provided temporary storage for these pallets while they awaited lling operations.

The success of this storage resulted in customer continuing to use Masy for their -20°C  finished drug substance needs.

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