Whenever room environmental parameters are critical to product quality Building Management System (BMS) designers face a choice regarding the control and recording of this GMP critical information… What to validate, and how?
Norman A. Goldschmidt
In order to comply with widely established GMP regulations requiring “minimizing the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air…” An evaluation of potential for cross-contamination via HVAC should be part of the risk assessment in multi-product facilities.
As outlined in the ISPE Risk MAPP[...]
This whitepaper outlines some important design considerations for Clean-in-Place (CIP) systems, which are ubiquitous in the pharmaceutical industry.
The goal for every CIP system is to remove residues from product contact surfaces. The residues must be reduced to pre-established criteria. Typically, critical process parameters for cleaning include the chemistry of the cleaning[...]
Is a Sustainable cGMP Manufacturing Facility Achievable?
In 1999, 16% of the world’s population consumed 80% of its natural resources. The United States, with 4% of the world’s population, consumed 25% of the world’s natural resources. (World Bank) Buildings in the US dominate energy consumption, either directly by way of the[...]
GSK’s energy efficiency retrofits and enhancements return $2 million to the company’s coffers. Changes in global climate are major concerns among scientists and the public alike.
Changes in global climate are major concerns among scientists and the public alike. Greenhouse gas emissions (e.g., carbon dioxide) resulting from human activities are considered[...]
The bad news is that energy efficiency has understandably never been job one in the pharmaceutical industry. The good news is that opportunities abound for real progress as a new emphasis on sustainability grows. The author offers more than a daily dose of industry-specific insight while outlining why higher efficiency[...]
The area directly surrounding RABS units has been the subject of discussion since the inception of RABS technology. The essential problem with these units is twofold:
1. Unlike isolators, there is no gaseous decontamination cycle to decontaminate the incoming change parts and doors after the unit is closed.
2. Unlike isolators, RABS[...]
A common challenge in the design of sterile filling and biotech facilities is selection of the appropriate type of pre-filtration to employ ahead of supply HEPA or ULPA filters serving processing areas. This document suggest an approach intended to assure compliance with applicable regulation and industry guidance – specifically, FDA 2004 “Guidance[...]
GSK US Biopharms, Global Manufacturing & Supply, Primary Supply & Antibiotics. Most pharmaceutical sites have a requirement for process chillers or for process refrigeration systems. Many of these operate inefficiently because operational demands have changed since the original design, and because improvements have been made to the efficiency of available component[...]
Engineers often use a ring distribution concept for mix-proof valve arrays and flow panels. With a ring, the CIP supply or return flow flushes through all of the piping to the distribution point without creating a deadleg. See Figures 1 and 2. Without the ring, in Figure 2 the valve[...]