Mr.Roger Cowan

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperatur ...

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ster ...

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity to hav ...