(Manufacturing.) Sterile and isolated production systems (espcially for parenteral dosage forms), including conventional cleanroom and restricted access barrier isolation systems (RABS) technology, supplies, and equipment.
October 2, 2006
By:
Maurizio Battistini
Pharmaceutical Technology
Glasses are important when operating in a sterile environment, and it is necessary to ensure that they will stand up to repeated sterilization processes without introducing contaminants. The glasses were subjected to numerous steam sterilization cycles to assess durability and microbial reduction. Results showed that the glasses most widely available on the market have been refined by the manufacturer to satisfy pharmaceutical customer needs by withstanding repeated sterilization cycles and minimizing contaminating particle release.
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September 2, 2006
By:
Richard J. Forsyth, Jeffrey Hartman, Vincent Van Nostrand
Pharmaceutical Technology
Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.
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May 1, 2007
By:
Kurt McCauley, John R. Gillis
Pharmaceutical Technology
A biological indicator (BI) measures the effectiveness of the sterilization process to which it is subjected. Factors such as the test organism, the packaging, the culture material, and the test system all influence a BI's resistance. Carrier material is an often-overlooked factor that also influences BI resistance. The authors examine various solid and liquid carriers, describe their properties, and investigate how they influence BI resistance.
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May 1, 2007
By:
Russell E. Madsen, Maik W. Jornitz, Theodore H. Meltzer
Pharmaceutical Technology
Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.
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May 1, 2007
By:
Geoffrey P. Jacobs
Pharmaceutical Technology
Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.
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May 1, 2007
By:
James P. Agalloco
Pharmaceutical Technology
The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated with the various definitions of overkill sterilization are explored.
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May 1, 2007
By:
James E. Akers, James P. Agalloco
Pharmaceutical Technology
Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.
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May 1, 2007
By:
Klaus Haberer, Korinna Vreden
Pharmaceutical Technology
Validating the sterilization process is extremely important in pharmaceutical manufacturing. The authors explore different types of sterilization processes and discuss the importance of finding the worst-case positions of loads or equipment to be sterilized and the worst-case conditions for each sterilization cycle. Biological indicators (BIs) can be used to simulate worst-case scenarios and determine the effectiveness of a particular sterilization process.
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April 25, 2007
By:
Maribel Rios
INTERPHEX Show Daily
Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.
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