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AT A GLANCE A large pharmaceutical manufacturer in Indianapolis, IN, partnered with Performance Validation (PV) to validate that its air handling systems in classified cleanroom airlocks effectively removed airborne particles, ensuring compliance with the updated EU Annex 1 requirements. Performing Room Recovery Testing for Air Handling Systems Performance Validation (PV) was tasked with verifying that […]
Read MoreArchives: Case Studies
Tailored Room Recovery Testing Solutions for CDMO Cleanroom Compliance
At A Glance An Indianapolis-based contract development and manufacturing organization (CDMO) for injectable pharmaceutical manufacturing partnered with Performance Validation (PV) for cleanroom recovery testing. During a client’s compliance audit relating to ISO 14644 and EU Annex 1 requirements, the CDMO realized they lacked proper testing documentation demonstrating room recovery requirements. This discovery led to the […]
Read MoreAhead of Schedule and Under Budget: Achieving 21 CFR Compliance with 24.5% Cost Savings in eQMS Validation for Vaccine Storage
At a Glance An Indianapolis-based logistics company looking to cold-store vaccines partnered with Performance Validation (PV) to validate its electronic quality management system (eQMS). The logistics company, which had GMP storage facilities with walk-in freezers, wanted to use their extra space to stockpile COVID-19 vaccines. Before this could happen, however, the company would need to […]
Read MoreEfficient Environmental Mapping for a Major Pharmaceutical Manufacturer’s Facility Expansion
At A Glance One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to perform environmental mapping in its brand-new facility in Research Triangle Park, North Carolina. The pharmaceutical manufacturer expanded its operations by building a new campus to increase production capacity. One of its buildings included a quality control laboratory […]
Read MoreOptimizing Auto-Injector Production: PV Validates High-Speed Assembly Machines
AT A GLANCE An equipment manufacturer of high-speed automated assembly machines in Illinois partnered with Performance Validation (PV) to validate its drive/reject assembly machine. The equipment manufacturer was a vendor for one of the largest pharmaceutical manufacturers in the Midwest. The pharmaceutical manufacturer needed to produce more auto-injector pens for its drug products, so it […]
Read MoreSTREAMLINING A CRITICAL VIAL PRODUCT LINE FOR A LARGE PHARMACEUTICAL MANUFACTURER
AT A GLANCE One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to inspect its vial production process. The pharmaceutical manufacturer had two main objectives: The PV team had nearly a decade of experience supporting the inspection process for the pharmaceutical manufacturer, which allowed them to build expertise with the […]
Read MoreBenton County Admin Building Case Study
At A Glance The Performance Validation Team completed a comprehensive commissioning project for the brand-new Benton County Administration Building in Kennewick Washington. The project broke ground in July of 2020, and reached completion in March of 2023. The new administration building spans three stories and encompasses 41,419 square feet, including a fully equipped basement. This […]
Read MoreHow Smoke Studies Optimized Room Pressurization for a Top 5 Pharma Manufacturer
AT A GLANCE A top 5 pharmaceutical manufacturing company in North Chicago, Illinois, partnered with Performance Validation (PV) to perform smoke studies in a building with 14 different areas for packaging, filling, mixing, and bottling. For each area, the team conducted three scenes: a baseline, a material airlock examination, and a personnel airlock examination. The […]
Read MoreCity of Marysville Civic Center Case Study
AT A GLANCE The Performance Validation Team expertly conducted a comprehensive commissioning project as the primary commissioning authority for the City of Marysville Civic Center. This new facility is a cornerstone of the downtown redevelopment plan, designed to create a one-stop campus for city services. Spanning 101,000 total square feet, the Civic Center integrates a […]
Read More21 CFR PART 11 COMPLIANCE ASSESSMENT
Based on the increased use of computer systems in the pharmaceutical industry,the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11regulations in March of 1997. This regulation provides the criteria for acceptance bythe FDA, under certain circumstances, of electronic records, electronic signatures,and handwritten signatures executed to electronic records as equivalent […]
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