Building a Scalable Temperature Mapping Program Across a Nationwide Network Managing temperature mapping across a single facility presents enough complexity. Scaling that effort across more than 40 distribution centers nationwide introduces an entirely different challenge. A leading healthcare supply and distribution organization required temperature mapping across its U.S. network of facilities, with environments ranging from […]
Read MoreCategory: Temperature Mapping
Digital Temperature Mapping Case Study: Transitioning a 3PL from Paper to Digital
Supporting a New GMP Facility Startup for a Growing 3PL Provider A third-party logistics (3PL) provider supporting pharmaceutical manufacturers opened a new facility in Pennsylvania, requiring GMP-compliant qualification and temperature mapping to support regulated operations. To meet startup timelines and regulatory expectations, the facility required initial Performance Qualification (PQ) temperature mapping for controlled room temperature (CRT) and refrigerated environments […]
Read MoreModernizing Sitewide Temperature Monitoring for Compliance and Efficiency
At a Glance A global pharmaceutical manufacturer sought to replace their digital and paper-based temperature monitoring systems with a single, secure, digital, continuous monitoring solution across its U.S. manufacturing site. The multi-year project covered every lab, freezer, cooler, warehouse, and stability chamber—requiring phased validation, coordination across multiple departments, and adaptation to shifting priorities during the […]
Read MoreCompliant Qualification & Temperature Mapping for a Logistics Company’s GMP Warehouse Facilities
AT A GLANCE A third-party logistics (3PL) company partnered with Performance Validation (PV) to qualify and conduct temperature mapping for its GMP warehouse facilities in Indianapolis, IN and Phoenix, AZ. To support the expansion of its pharmaceutical and life sciences operations, the company needed to design, construct, and qualify GMP-compliant warehouse spaces capable of safely […]
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 MoreComprehensive Temperature Mapping for Automated Storage in Research Triangle Park
At a glance In a landmark project within North Carolina’s Research Triangle Park, Performance Validation (PV) executed a comprehensive temperature mapping study for a leading pharmaceutical manufacturer’s state-of-the-art Automated Storage Retrieval System (ASRS) facility. Spanning two crucial storage areas—Controlled Cold Temperature (CCT) with >9000 pallet positions and Control Room Temperature (CRT) with >8000 pallet positions—the […]
Read MoreBlast Freezer Qualification
Overview A Contract Manufacturing Organization (CMO) in Indiana specializing in bulk drug substance, formulation, filling, and finishing operations, needed to add a Blast Freezer system, designed to freeze up to 20 L of product from 8 °C to ≤ – 60 °C. The blast freezer was the first of its manufacturer and design complexity for […]
Read MoreDry Goods Autoclave
The Challenge Recently a client contacted Performance Validation requesting assistance with the cycle validation for a dry goods autoclave, which had failed to achieve sterility. A biological indicator included in the validation demonstrated growth on completion of the autoclave cycle. The Solution On review of the dry goods autoclave cycle, Performance Validation (PV), identified the […]
Read MorePharmaceutical Manufacturing – Autoclave Steam Sterilization
The Challenge A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise. Additionally, they only had one autoclave to support […]
Read MoreCold 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 […]
Read More
