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 […]
Read MoreIncubators/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 […]
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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 […]
Read MoreCryogenic 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 […]
Read MoreAutoclaves/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 […]
Read MoreThe 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 […]
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The Challenge A medical technology company with no previous Computer System Validation (CSV) experience needed to complete the validation of their Global Shop Solutions (GSS) enterprise resource planning (ERP) computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures). The ERP software would be […]
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The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) on a new aseptic filling line with active RABS barrier configuration. Additionally, modifications to two existing aseptic filling lines were completed in conjunction with the new filling line. The critical supply chain required completion of airflow visualization in a short window. The video […]
Read MorePerformance Validation has extensive experience with controlled temperature and humidity storage mapping 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 placement for mapping, identifying […]
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The Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) after an upgrade to a high-volume filling line with new RABS barriers. Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade. The video evidence of the Critical Airflow Visualization studies […]
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