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73 - Air sampler disinfection

CLEANING AND DISINFECTION OF MICROBIAL ACTIVE AIR SAMPLERS IN CLEAN ROOM INTRODUCTION All the materials that are used with a microbial air sampler (protective aspirating head, aspirating head, body of the air sampler, bags, etc) should be cleaned and disinfected before the sampling cycles.

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72 - The choise and use of an active Microbial Air Sampler

THE CHOISE AND USE OF AN ACTIVE MICROBIAL AIR SAMPLER The microbial air sampler must be carefully chosen because the characteristics of the instrument may impact heavily on usability, on implementing deadlines and consequently the final cost of such activities in terms of buying and managing the facility, man hours and efficiency of operations The air sampler should be easily cleaned and sanitized and be constructed of materials compatible with the most common detergents and biocides such as isopropyl alcohol, hydrogen peroxide and sodium hypochlorite.

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71 - TRIO.BAS GAS Microbial content in compressed air and gas – SOP Document

MICROBIAL CONTENT IN COMPRESSED AIR AND GAS – SOP DOCUMENT Introduction The following SOP is a guide line to prepare a local SOP for the test of compressed gas or air used in Clean Room. Standard Operating Procedure OBJECT Quantitative bioburden collection in compressed gas lines in Clean Room.

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70 - Test of spontaneous generation

The history For many centuries many people believed in the concept of spontaneous generation, the creation of life from organic matter. Spontaneous generation is the hypothesis that some vital force contained in or given to organic matter can create living organisms from inanimate objects. Spontaneous generation was a widely held belief throughout the middle ages and into the latter half of the 19th century. The Italian Francesco Redi disproved spontaneous generation for large organisms by showing that maggots arose from meat only when ies laid eggs in the meat.

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69 - TRIO.BAS Air Sampler Biological ef ciency test according ISO 14698-1

CMA – CENTRO DI MICROBIOLOGIA APPLICATA Via Cusago 154 20019 Settimo Milanese Laboratorio accreditato ACCREDIA n. 1087 Direttrice Dr Miriam Magrì. Biological efficiency testing of several active microbiological air samplers according ISO14698-1 in a dedicated microbial wind tunnel.

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68 - The ideal m/s speed of the impact air on agar surface of active air sampler

The ideal m/s speed of the impact air on agar surface of active air sampler. The indications of the ISO 14698 about the ideal m/s speed of the air that impacts on the agar surface of an active microbial air sampler are quite general. Flow rate: sufficiently high to ensure the detection of low levels of contamination but weak enough to not dehydrate excessively agar medium; Flow velocity and impact: sufficiently high to be sampled microorganisms of size less than 1 micron and sufficiently weak to avoid damage during the impact.

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67 - Air sampling in food premises

Safe food with microbial air monitoring in production premises The microbial air monitoring in food, beverage and dairy production premises is an important factor to be considered. In fact clean air in production and storage building means better quality of food, longer self-life and better customer satisfaction. Cleanrooms and Controlled environments play an important role in the prevention of contamination during the production of food and food supplements. They are most often built around food packaging processes, where there is a high potential for exposure of the finished food product to the atmosphere or people. Ensuring that the environment within the room remains uncontaminated requires continuous monitoring of several variables including microbial air monitoring.

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66 - Air sampling in Hospital

Microbial contamination monitoring in operating theatre of hospital The microbiological contamination in operating theatre is an important parameter to be considered to reduce / eliminate the risks of infections in hospital during surgery. The microbiological monitoring of this critical environment has two specific goals: A. to confirm the Heating Ventilation Air Conditioning (HVAC) system and the sterile unidirectional air flow are working regularly; B. to confirm the staff is following a correct aseptic protocol.

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65 - Microbial air monitoring in Isolators

Monitoring of atmosphere inside isolators is very critical in maintaining high quality standards. In fact there are risks in using portable environmental samplers because they must be introduced each time you sample. “TRIO.BAS Isolator” from ORUM International in Milan is a dedicated instrument for this application. The sampling aspirating chamber of “TRIO.BAS Isolator” is compact, manufactured in stainless steel; the command – control unit is separated and positioned outside from the isolator. The compact design save space inside the isolator. The connection is only for power and doesn’t compromise the isolator integrity. No vacuum, valves and s/s tubing are involved. The use of “Shift Head” sterile certified aspirating head simplify the daily activity and reduce contamination risk. Three independent separated aspirating chambers are connected to the central command unit.

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64 - Full traceability

GAP (Good Air-Monitoring Practice) in Clean Room: Full Traceability The Good Manufacturing Practice and Pharmacopeial request that all the data collected during the microbial air monitoring are registered with full traceability. The TRIO.BAS air samplers include the Barcode 1D or 2D or the Radio Frequency Identification System (RFID) to collect air volumes, date, hours, operator name, location name, plate identification. All these data cannot be modified according to the official inspectors request.

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63 - Good Air Monitoring Practice

The “GAP” (Good Air-Monitoring Practice) requests that all the material used for the microbiological monitoring of the environment is sterile and the inspector authorities ask to document the sterilization compliance. The “Shift-Head” sterile disposable aspirating head for microbiological air samplers of the TRIO.BAS air sampler family has been produced for this purpose. Each “Shift-Head” from ORUM International in Milan is individually packaged and includes a sterilization certificate. All the preparations connected to cleaning, sterilization, packaging, documentation of the metal aspirating heads are eliminated saving time and in conformity with the requests of the inspectors.

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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.

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