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According to the Code of Federal Regulations (21 CFR 211.80), raw materials and components used in pharmaceutical manufacturing must be received, stored, and handled in a manner designed to prevent damage, contamination, and any other adverse effects. Incoming materials must be treated and handled according to approved written procedures and current industry standards. Batch integrity must be maintained from beginning to end, and record keeping begins with the Certificate of Analysis (C of A) delivered with each shipment. All incoming materials and components must be treated as "quarantined" until proper sampling, inspection, testing, and release can be carried out by in-house personnel. For this reason, receiving and warehouse areas must be designed with adequate space and security measures to separate quarantined and materials under test from those released for use.
Raw materials entering a chemical synthesis API facility typically consist of liquids, solids, and gases. They tend to be extremely pure in quality but vary greatly in character from innocuous to toxic, flammable, or explosive. Also, these raw materials are received in a variety of forms including packages, drums, totes, or carboys. Depending on the quantities, once they are received, they are also stored in a variety of methods.
Each project we design has its unique raw materials and logistics requirements. Our staff has experience with a wide variety of receipt and storage systems. These include both conventional and cGMP designs for:
- Drum/bulk container storage
- General purpose raw material warehouses
- Hazardous storage warehouses
- Weigh and break
Parsons' staff is experienced in designing systems from very manual to very sophisticated automated systems with Auto Storage/Retrieval systems. Also key to the design is our knowledge containment of the raw materials for operator safety, spill prevention, and quarantine.
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