Effective Project Execution with Minimal Disruption to Plant Operations

Case Study #4_Air Compressor_Commissioning_Qualification

Brevitas’ dedicated professionals oversaw the commissioning of three strategic projects within the engineering portfolio for a leading pharmaceutical company. With our expertise in project management and technical assurance, we successfully addressed compliance gaps, improved system redundancy, increased raw material testing capacity, and reduced raw material testing cycle times.

Industry

Pharmaceuticals

Area of Expertise

Engineering and Capital Projects

Duration

10 months

Services Provided

  • Program/Project Management
  • Commissioning & Qualification
  • Training Solutions

Impact

Client operations were at risk due to citations during a regulatory inspection. Project management and the commissioning of new equipment and facilities was pivotal in addressing compliance concerns, without jeopardizing day-to-day manufacturing operations.

Business Challenge

Our client is a leading pharmaceutical company whose operations were at risk due to citations after a regulatory inspection. Brevitas consultants were brought in to support our client in project management and commissioning of new equipment as well as oversee the upgrade of its Canadian facility to meet regulatory guidelines.

Our Approach

Because of the sensitive nature of our client’s work, our consultants worked simultaneously during multiple phases of these projects and delivered the projects on time in a period of 10 months with minimal impact to operations. During this period Brevitas consultants coordinated and supervised multiple contractors to ensure regulations, safety and building codes were met during construction. They also led the development and execution of commissioning protocols according to vendor and client specifications. A stringent verification process was maintained and the consultants took immediate corrective actions when required during equipment commissioning.

Results Achieved

Leveraging our unique project management and commissioning expertise, our client was able to implement new equipment and facilities to address compliance concerns and meet regulatory requirements. Our key accomplishments include:

  • Developed Standard Operating Procedures (SOP), conducted technical documentation reviews and ensured that a preventative maintenance program was in place
  • Upgraded a Class E area into a Class C and D 400 ft2 fully functioning sampling suite and its associated utility systems, that met Good Manufacturing Practice (GMP) requirements
  • Delivered a new stability chamber that met increased capacity
  • Collaborated with the vendor of the new compressed air generation system to assure all specifications were met and smooth transitioning of operations including start-up training for multiple user groups

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