Compliance and Validation Services Stuff


Facilities & Equipment Commissioning

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PharmaSys can assist your company with commissioning and facilities validation for exiting facilities, newly constructed facilities and for facility upgrades.

Capabilities

The PharmaSys staff has performed commissioning and facilities validation for the following equipment/systems:

  • Environmental control systems including HVAC systems, Building Management Systems (BMS) such as Metasys, Siemens Apogee and temperature/humidity/differential pressure control systems.

  • Plant utility systems including water-for-injection (WFI),deionized water (DI), steam systems, compressed air systems, alcohol systems and nitrogen systems.

  • Air Handling Unit (AHU) qualifications including the verification of as-built drawings, utility and component verification, control loop testing, audit of HEPA Filter Integrity Tests and audit of Test, Adjust, and Balance (TAB) Reports.

  • Qualification of critical areas in manufacturing such as production rooms, sampling areas, and primary packaging areas. Testing may include the verification of as-built drawings, utility and component verification, control loop testing, audit of HEPA Filter Integrity Tests, audit of Test, Adjust, and Balance (TAB) Reports, temperature and relative humidity mapping/monitoring (static and dynamic), calculation of room air change rates, differential air pressure and direction tests and viable and non-viable particulate testing.

  • Qualification of ancillary production rooms, production area corridors, airlocks, wash rooms and technical rooms inside production areas.

  • Qualification of warehousing including receiving, warehouses, cool and cold storage rooms, tank farms, changing rooms, external corridors and offices.

If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.

 

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