LIFE SCIENCES

The pharmaceutical / life sciences industry adds another level of requirements for documentation. PREMIER has always made it a priority to provide our customers with exceptional documentation for our control systems. With this philosophy in place, it has been a natural progression to provide the level of documentation required for this industry thus meeting even the most stringent testing and validation requirements.

 

PREMIER has delivered a variety of services to the pharmaceutical industry:

  • Master Plan

  • IQ/OQ/PQ Protocols

  • Protocol Execution

  • Production Equipment Control Systems

  • Building Automation Control Systems

  • Factory Acceptance Tests

  • Control System Testing and Validation

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The PREMIER staff has performed computer validation services on the following systems:

  • Control systems for sterile/biotech equipment/systems including lyophilizers, sterile/bioreactors, filter systems, filter integrity test systems, pressure/temperature controls, packaging systems and environmental controls.

  • Laboratory systems including ovens, coolers, freezers environmental controls, laboratory information systems (LIMS), chromatography data collection systems and instrumentation. Other instruments validated include UV-Vis spectrometers, FT-IR spectrometers, high-performance liquid chromatography (HPLCs), gas chromatographs (GCs), and capillary electrophoresis systems (CEs).

  • Information management systems including electronic documentation management systems, laboratory information management systems (LIMS), maintenance management systems (MMS), manufacturing resources planning system (MRP II, ERP), order management systems (OMS), supervisory, control and data acquisition systems and (SCADA) systems and manufacturing execution systems (MES).

  • Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls, and automated sequences.

  • Programmable Logic Controllers (PLCs) utilized to control pharmaceutical process equipment.

  • Database management systems including, Oracle, Sybase, MS SQL server, DB/2, and MS Access.

  • Computerized Clinical Data Acquisition and Management Systems.

  • Solid dosage, ointments, creams, liquids and sterile packaging lines including check weighers.

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