Microbial Manufacturing

Conduct Research

• Lean Manufacturing and Pharma: An Interview with Phil Emard
  adopted by more drug companies, and not just for manufacturing. magazine and Quality New Jersey co-sponsored an event in Princeton, N.J. hosted by Celsis, Inc. The event focused on Lean Manufacturing, and the role that Rapid Microbial Monitoring (RMM) technology can facilitate pharmaceutical...
• Vaccine Manufacturing Deja vu: A 483 Review
  , for instance, it was found that "specified [microbial] limits were not achievable, so no limits were applied." Other 483 issues for all manufacturers included: Inadequate auditing of raw material or equipment suppliers. Poorly specified alarm levels for bioburden levels, and failure to study reasons...
• Lean Manufacturing and Pharma: An Interview with Phil Emard
  pharma manufacturing system? PE – Quality Assurance, including testing for microbial contamination, is an area often overlooked when drug manufacturers implement Lean. This is a mistake, and RMM can reduce lead time significantly. Celsis made the point that its system can reduce testing time from...
• Air Emissions from the Automobile Manufacturing Industry: A Bio-Oxidation Pilot Study of Paint Emissions Control
  for VOC removals at paint manufacturing. applications. After the initial start-up and testing it was decided to allow the bio-oxidation unit to. run at the existing conditions for several weeks in order to achieve more extensive microbial. growth in hopes of achieving even higher removal efficiency...
• Pharmaceutical Application for Water Activity (.pdf)
  Knowledge of the water activity of pharmaceutical solids (proteins, drugs, and excipients) is essential to obtain a solid dosage form with optimal chemical, physical, microbial and shelf-life properties. Water activity (aw) influences the chemical stability, microbial stability, flow properties...
• Blending Microbes Demands Gentle Touch
  according to their ability to provide: . Precise and consistent blends containing its target microbial load. . Rapid mixing to maximize manufacturing throughput. . Rapid, thorough cleaning for rapid changeovers. . Gentle blending with minimal friction and shear to protect bacterial cells and other...
• An Interview with John Albright, Regulatory and Compliance Manager, Celsis
  . In this brief interview, John Albright discusses the specific benefits of Celsis' platform. - We're hearing a lot more about rapid microbial methods in general. Celsis has always emphasized the connection between Lean Manufacturing and its product line in its message. But most people associate Lean...
• Pulsed UV Light Systems in Clean Room Isolators
  isolator. The common feature of clean room devices is the increased separation of the manufacturing activity from the human clean room technician. A key function of clean room devices is to control microbial contamination near and within the manufacturing area. This is accomplished by air flow through...
• Minimizing Risk in Sterilization Validation
  to aseptic processing conditions. The USP states, The facility for sterility testing should be such as to offer no greater a microbial challenge to the articles being tested than that of an aseptic processing production facility. While contamination is the ultimate nightmare for any manufacturing...
• Water Activity: The Key to Pet Food (.pdf)
  provides the most valuable. determining if a food is safe from microbial growth. information about product safety and quality. It is used effectively in the Pet Food Industry and. should be an integral part of manufacturing and any. Water activity represents the energy status of the. future regulations...

Engineering Web Search: Microbial Manufacturing