The cost of designing and constructing a manufacturing facility to produce a bulk biological active ingredient for a biotechnology-derived pharmaceutical product is becoming increasingly expensive in today’s biotech industry.
During the past 10 years, a number of publications have suggested that 316L stainless steel alloys with extremely low concentrations of manganese (referred to as ultralow-manganese alloys, which contain less than 0.05% Mn) are superior in corrosion resistance as compared to more conventional 316L alloys.
The cleanroom industry is acutely aware of the many possible sources of contamination that threaten cleanroom operations. The most significant threat is also the threat that is easiest to control–the humans working in the cleanroom.
Almost any discussion today about what regulatory focus is and where it might be going, inevitably becomes a discussion about Risk Management. Almost 1 12 years after the FDA announced their initiative on Risk Management for pharmaceuticals and biologics, many companies are still in the process of understanding the ultimate goals that the FDA hopes to achieve.
Goals of the worker safety, environmental regulatory management, and contamination control groups are too often considered to be unrelated, if not conflicting. A more positive approach would be to treat the groups as parts of a collaborative triad.
In my previous two columns, I described current “wet” and “dry” technologies for particle removal, sorted by my estimate of particle size at which their use is limited. (Please refer to the tables in each article.) In this third column I will comment on the general transition from “wet” to “dry” critical cleaning. A previous literature article1 shows how approaches have changed over 15 years.
There once was a time when buying a filter for wet cleans was a fairly uncomplicated process. Fifteen years ago, fabs could purchase just one type of fluoropolymer filter to address the chemical compatibility concerns of almost every wet chemistry application; 0.2-micron filters were the norm, most were 10 inches in length and there were two, maybe three main filter suppliers.
Process Analytical Technology (PAT) is the usage of sensory data in any process. PAT was initially developed for telemetry. Telemetry is the transmission of measured sensory data via wire, cable, telephone, radio, or wireless technology. Sensor telemetry has been implemented and employed extensively by NASA for over 45 years.
The design and construction of cleanrooms and contamination controlled facilities often represent a complex undertaking for a project team. In addition, many times these projects must be delivered on an accelerated schedule in order to meet the client’s requirements that are the result of marketplace pressures.
A Surface Active Agent can be described as a substance that can modify the surface properties of liquids or solids. In cleaning applications, these agents work at the boundary layer between soil and solvent.
We recently participated in a valuable, thought-provoking workshop;1 this annual conference deals with the confluence of military requirements for critical applications of environmental, regulatory and/or legislative changes, and of practical, achieved approaches to production and maintenance of product quality.
“Dry” cleaning does not mean cleaning your suit with perchloroethylene or CO2. “Dry” cleaning means that the cleaning work is not done with the parts immersed in liquid.
There's a lot going on with A2C2 in 2004. First of all, we have done away with the tongue-twister “A-squared C-squared” and are simply calling ourselves A2C2. Plus, to better represent the vast areas of technology that we cover, our tagline has been changed to “Contamination Control • Cleanrooms • Critical Environments.”
Faster processing, improved quality assurance, and simplified cleaning validation are critical factors fueling the impetus towards disposable systems for pharmaceuticals and biopharmaceuticals processing.
We must consider contamination control inside and outside of the cleanroom. In fact, some of the frontiers of contamination control efforts are taking place far outside the confines of the typical fab facility - outer space.
Last month we discussed Surface Acoustic Wave (SAW) detectors for monitoring Airborne Molecular Contamination (AMC). We indicated that contaminants on the sensor chip can be identified using Time of Flight Secondary Ion Mass Spectrometry (TOF-SIMS).
The aftermath of the destruction of the World Trade Center (WTC) buildings is indelibly etched in our memories. Human tragedy—international, national and local political changes—economic loss—environmental consequences—are still related and debated by the global media.
There are numerous issues to consider when evaluating gloves for your critical environment. It is imperative that the critical environment gloves provide you with the assurances you need for your application.
With the economy in the doldrums, 2003 was tough on contamination control businesses. With no visible sign that the semiconductor industry was ready for a comeback, there was little done to expand facilities or move toward 300mm operations. And almost all the action that did occur, took place in Southeast Asia.
There aren’t many industries where minimizing product loss and completely eliminating emissions are as critical as the pharmaceutical industry. As a result, the use of mechanical seals in production facilities is increasing, since the nature of mechanical seals enables leakage elimination.
