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62 - Position of samplers in Cleanroom
The microbiological active air sampler should, in some particular situations, vertically positioned. This situation could be specifically problematic in Clean Room. If the air sampler is on top of a trolley and is transferred to the more critical points, it is necessary to fix the air sampler to obtain a complete stability. It is for these reasons that a new holder has been developed and produced by ORUM International in Milan. The new “Stand Up” is quickly and easily attached to any portable TRIO.BAS air samplers. It provides a sturdy and robust platform that greatly improves the stability of the air samplers, whatever their location, from Clean Room and Isolator to operating theatres. It is also useful in dairy, food premises and even composting sites.
Learn more61 - Choose and comparation of samplers
Active Microbial Air Sampler idea The portable active microbial air sampler collects a pre-determined volume of air that impacts against agar-based growth culture medium contained in a Petri dish or contact plate. The aspiration is produced by a motor-fan. The plate is then incubated at appropriate temperature and the number of colonies (Colony Forming Unit = CFU) per plate are typically reported to 1.000 litres of air.
Learn more57 - SOP Microbial Compressed Air/Gas Sampling according ISO 8573-7
Object The purpose of this document is to describe the procedure for compressed air / gas sampling, and reporting of the viable airborne particulates as part of environmental program, using TRIO.BAS GAS Microbial Air Sampler. Purpose This procedure applies for sampling and evaluation of compressed air quality for viable particulates using a Microbiological Air Sampler in Clean Room. The purpose is to certify the absence of microorganisms in 1.000 litres of compressed gas/air.
Learn more53 - The Barcode application in microbial environmental monitoring
The application of bar-codes to the microbiological air monitoring procedures can help save time, to better control the activity of the operator and to achieve a complete traceability of the test.
Learn more51 - Training of personnel in Cleanroom, Isolator, RABS according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1195
The personnel performances Good personnel performance plays an essential role in the control of contamination, proper training and supervision are central to contamination control. Aseptic processing is the most critical activity conducted in Microbiological Controlled Environments, and manufacturers must pay close attention to details in all aspects of the endeavor. Rigorous discipline and strict supervision of personnel are essential in order to ensure a level of Environmental quality appropriate for aseptic processing.
Learn more49 - Simple tips to facilitate the phenotypic identification of aerobic microorganisms after collection and incubation in Petri dish.
SCOPE OF IDENTIFICATION The purpose of the bacterial air monitoring is not only to count the total number of microorganisms for cubic meter (CFU/cm3), but also to identify the microorganism. STARTING PROTOCOL A. The best phase to pick up a colony from the agar surface for identification is the “LOG” phase (not the “LAG” and “Stationary”), because they are behavior properly being at the top of the health.
Learn more47 - Glossary for Microbiological Air Environmental Monitoring
Microbiology according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1201, 1202. -Airborne Particulate Count – The total number of particles of a given size per unit volume of air. -Airborne Viable Particulate Count – The recovered number of CFU per unit volume of air. -Air Changes – The frequency per unit of time that the air within a controlled environment is replaced. The air can be recirculated or totally replaced.
Learn more46 - Culture media and diluents – Selection of Growth Media in Cleanrooms, RABS, Isolator
Microbiology according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments -Page 1201, 1196. - Culture media and diluents The type of medium, liquid or solid, used for sampling or plating microorganisms depends on the procedures and equipment used. Any medium used should be evaluated for suitability for the intended purpose. The most commonly used all purpose solid microbiological growth medium is soybean casein digest agar. As previously noted, the medium can be supplemented with chemicals that counteract the effect of various antimicrobials.
Learn more45 - Identification of microbial isolates
Identification according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1201 A successful environmental control includes an appropriate level of identification of the flora obtained in sampling. A knowledge of the flora in controlled environments aids in determining the usual microflora anticipated for the facility and in evaluating the effectiveness of the cleaning and sanitation procedures, methods, agents and recovery methods. The information gathered by and identification program can be useful in the investigation of the source of contamination, especially when recommended detection frequency are exceeded.
Learn more44 - Environmental Microbial Data interpretation in aseptic processing.
We report what USP 38 – USP Pharmacopeial Conventions says at page1199 in the Chapter “Further considerations about data interpretation” of the document “Overall Management of a microbiological control program”. ZERO CONTAMINATION “In the high quality environments required for aseptic processing, detection frequency typically is low. As can be seen from the rates recommended in the enclosed table.
Learn more42 - Suggested Frequency and Microbial Recovery rate of Sampling for Aseptic Processing Areas
The USP 38 – The United States Pharmacopeial Document – Official from May 1, 2015 – presents on page 1197, Table 2 the “Suggested Frequency of Sampling for Aseptic Processing Areas”.
Learn more37 - The advantages of the use of a 3 heads air sampler in isolators and RABS
The TRIO.BAS isolator microbial air sampler has been developed specifically for isolators and RABS.
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