Project Solution: Temperature Mapping

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 […]

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 […]

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 […]

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 […]

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 […]