Case Studies Archive - Page 9 of 10 - Performance Validation

Cold Storage (Refrigerators/Freezers)

Performance Validation has extensive experience with refrigerators, freezers, and sub-freezers from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers and low-temperature loggers. Performance Validation resources have expertise in determining […]

Overview A Greenfield construction project of a new administrative office for an Indiana Pharmaceutical Manufacturer required building commissioning of all utility systems, including HVAC, chilled water, plant steam, heating hot water, compressed air, electrical/lighting, and sanitary and storm sewer systems. The SolutionThe pharmaceutical Manufacturer retained Performance Validation (PV) to perform the building commissioning. PV was […]

Overview Life within an API manufacturer can be characterized as dynamic, fluid and fast paced. Projects may include large capital projects for the installation of new equipment or remodeling/repurposing of existing equipment and spaces. Alternatively, projects may consist of minor piping changes, equipment additions, decommissioning, repairs, pump replacements, solvent additions, pack-out equipment, and facility upgrades. […]

woman and man in lab coats, checking equipment

Overview A cell culture laboratory within a large Midwestern pharmaceutical company needed to upgrade their current cell freezing process. the project included replacing an older and increasingly unreliable controlled rate freezer with a new controlled rate freezer. Additionally, the actual freezing rate of the cells within the controlled rate freezer was needed to be determined […]

Overview A small Midwestern drug distribution warehouse needed to demonstrate temperature control throughout storage areas of the warehouse in accordance with USP controlled temperature requirements. Being a small distributor, cost was a major consideration. The Solution Performance Validation (PV) was selected for the project because of their temperature mapping expertise, internal equipment inventory and history […]

Incubators/Stability Chambers

Incubators/Stability Chambers Performance Validation has extensive experience with incubators and stability chambers from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers. Performance Validation resources have expertise with determining logger […]

closeup of jet engine; jet is parked on tarmac

The Challenge A large international airline company needed to have temperature-controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs). As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for […]

Cryogenic Storage/Controlled Rate Freezers

Cryogenic Storage/Controlled Rate Freezers Performance Validation has extensive experience with cryogenic storage and controlled rate freezer qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of Kaye Validators and thermocouples. Performance Validation resources have expertise with calibrating thermocouples in and […]

Autoclaves/SIP

Autoclaves/Sterilizers/Steam-in-place (SIP) Performance Validation has extensive autoclave and steam-in-place experience from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of Kaye Validators, thermocouples, self-contained biological indicators (Bis), and BI incubator. Performance Validation resources have expertise with identifying […]

Hospital Expansion Commissioning

The Challenge A large hospital network planned a significant renovation/expansion to an existing hospital facility located on the south side of Indianapolis. The project included an all new power plant, a new surgery suite, and a six floor patient tower to be phased in around the existing operational facility. The project design adopted energy-efficient solutions […]

Donna Griffith

Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.

Schedule with Donna Griffith

Brad Henry

Vice President of Services Products - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry

John Underwood

Vice President of Services Delivery - With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.

Schedule with John Underwood

Archives: Case Studies

Cold Storage (Refrigerators/Freezers)

Pharma Admin Office Building Commissioning

API Verification Support

Controlled Rate Freezer Qualification of a Cell Culture Laboratory

Temperature Control of a Drug Distribution Warehouse