Challenge

A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:

• Compressed Air Generation and Distribution
• Nitrogen Distribution
• Process Alcohol Distribution
• Plant Steam Generation
• Pure Steam Generation and Distribution
• Vapor Compression Distillation Pretreatment Unit
• Two (2) Vapor Compression Distillation Units
• Cold Water for Injection Distribution
• Hot Water for Injection Distribution
• Purified Water Distribution
• Drive-in Refrigerator
• Three (3) Walk-in Refrigerators
• One (1) Walk-in Freezer
• One (1) Drive-in Freezer
• Two (2) Reach-in Freezers
• Ten (10) Air Handling Units
• Three (3) Facility Management Systems

Solution

Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations. PV was responsible for:

• Development of the project Commissioning, Installation, Operational, and Performance Qualification plans.
• Identifying the key process requirements to be included in commissioning, installation, operational, and performance qualification.
• Developing, executing, and compiling commissioning, installation, operational, and performance qualification packages, which contained comprehensive functional and quality testing.
• Providing active leadership and communication throughout the duration of the project with client stakeholders and equipment vendor, helping the project team to identify and avoid potential bottlenecks.
• Managing and scheduling all project work to ensure that each deliverable was completed in accordance with the client schedule.

Results

All systems included in PV’s scope were successfully installed, commissioned, and qualified in accordance with the project schedule; allowing the site to meet their projected submission timeline.

The PV Advantage

Performance Validation coordinated with multiple stakeholders to successfully complete all required commissioning and qualification of the systems included in our scope of work. By identifying and incorporating key process requirements associated with each system, PV was able to deliver robust commissioning and qualification packages that fully tested the installation, functional, and quality attributes of each system.

Benefits

The client has fully commissioned and qualified utilities, chambers, air handling units, and facility management systems serving their new production building supporting a planned capacity increase of 8 million liters per year.

About Performance Validation:  Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.

Have a question or desire more information about Performance Validation? Please use our Contact Us form or contact:

Brad Henry
VP/ Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495