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37 - 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.
Learn more36 - The advantages of the use of a 3 heads air sampler in Clean Room
The TRIO.BAS microbial air sampler has been developed specifically for Clean Room. Several are the advantages.
Learn more35 - Certificate of conformity
The TRIO.BAS air samplers: fulfil the requirements of: · ISO Standard 14698-1 – 2004 Guidance for Industry on Sterile Drug Products by Aseptic Processing – Current Good Manufacturing Practice · FDA – 1987 Guideline on Sterile Drug Products by Aseptic Processing · ACGIH – Guideline for Assessment of Bio-aerosol in the Indoor Environment · ASTM – Draft Protocol – Committee D22.05.06 · USP Chapter <1116> Microbiological Evaluation of Clean Rooms and Controlled Environments · EU Guide for GMP – Manufacture of Sterile Medicinal Products Control Medicines and Inspection
Learn more34 - Positioning of microbiological air samplers in Clean Room and Controlled Environment
The “TRIO.BAS” microbiological air samplers have the possibility to use different holders and tripods for different positioning (vertical, horizontal, oblique). The “TRIO.BAS” may also be used in horizontal or vertical positions without the use of holder or tripods, due to their shape. The environmental microbiologist should chose the system that best covers his needs in his specific environment.
Learn more33 - Correct aseptic sampling during air sampling monitoring
The correct sampling is fundamental to avoid a microbial contamination with possible wrong results at the end of the analytical process. It is for this reason that all the staff involved in the sampling process should be trained. We are reporting some Guide Lines that should be distributed and explained to all involved personnel.
Learn more32 - Chromogenic media for colorful air microbial detection - SOP
The chromogenic media can be used for the direct identi cation of some microrganisms present in the air. An example of chromogenic media to be adopted is the “CHROMagar Orientation” of the companyCHROMagar that is succesfully used in the clinical eld, as well as food/beverage/envirnoment microbial quality control. This is a non-selective agar, similar to a TSA, but with the addition of chromogens that will allow the bacteria to grow in different colors, depending on the species.
Learn more31 - Performances of TRIO.BAS air sampler according ISO 14698
Airborne, Alert Level, As-built, AT-Rest, Bacteria, Bio-contamination, Cleaning, CleanRoom, Contact Plate, Controlled Environment, Culture Medium, Disinfection, Micro-organisms, Impact-Sampler, Risk Zone, Sampling Devices, Sampling Plan, Sterilization, Unidirectional Air Flow, Validation, Viable Particles.
Learn more30 - TRIO.BAS mod. Trio air sampler: WHY?
There are several reasons to adopt an air sampler with 3 aspirating heads 1. Plate Count Agar plate on left, up, and right aspirating heads (1, 2, 3) to calculate an average result and to obtain a more reliable and realistic number of Colony Forming Unit (CFU) to produce a valid statistical evaluation of the results, according to GMP (Good Microbiological Practice)
Learn more29 - SAS Surface Air System History
DATE NAME CHARACTERISTICS 1976 BAPD Slit to agar model 1977 BC SAS Anderson type air sampler 1978 SAS Prototype 1979 SAS Surface Air System Metal case with separate heavy battery metal case 1982 SAS Compact Metal body with incorporated heavy battery 1984 MTM-3 Stationary unit with 3 aspirating head 1992 SAS Super 90 Plastic.
Learn more28 - USP Regulation 797 for sterile compounding
Issued by the non-pro t US Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), “USP Regulation 797” is the rst enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest version became of cial on June 1, 2008. “USP 797” is a broad regulation that covers a variety of pharmacy policies and procedures. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparations.
Learn more27 - Mapping for the Microbiological Environmental condition monitoring in food production
It has been recommended that food processing plants adopt air monitoring programs to detect possible contamination sources in their regular HACCP program. Juice, ready-to-eat foods, pasta, meat, dairy and other food processing facilities have been advised to establish a system for weekly air monitoring. Air sampling of various areas (finished product, protein, fresh produce areas, etc.) yield information as to possible microbial contamination. That is to say, knowing the microbial population, number of colony forming units per cubic meter of air (CFU/m3) of a given area can be predictive of possible food contamination possibilities, e.g., yeast, molds, and pathogens.
Learn more26 - Maintenance and Calibration of air sampler according GMP and GLP – EN 14042
Chapter 12 “Quality Assurance” of the European Standard EN 14042 – “Workplace atmosphere – Guide for the application and use of procedures for the assessment of exposure to chemical and biological agents”. “It is good practice to set up a Quality Assurance scheme for the maintenance and calibration of the samplers.
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