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13 - Microbiological Air Monitoring in Operating Room

The prime function of a “Ventilation System” or a “Heating Ventilation Air Conditioning System” (HVAC) in an operating theatre, intensive treatment units and isolation suites is to closely control the environment and air movement of the space that it serves in order to contain, control and reduce hazard to patients and staff from airborne contaminants, dust and harmful micro-organisms.

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12 - Number of location and measurement for a reliable microbiological air testing

The people involved in a daily microbiology air sampling activity know quite well the frequent difficulties to obtain reliable results even in the same closed environment where the conditions are constant. The reasons are several: uneven distribution of micro-organisms in the air, inconstant biological activity of micro-organisms, influence of operator, air sampler, media, etc. The goal is to obtain results that are comparable with the previous data.

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11 - Mycobacterium tuberculosis bioaerosol sampling

Mycobacterium tuberculosis is a very well known old enemy that after some decades of relative “sleeping” is now again a “new emerging” disease. The World Health Organisation (WHO) estimated more than 8 million new cases and 3 million deaths are occurring annually. The micro-organism is spread by the airborne transmission of droplets produced by infectious individuals while they are sneezing, speaking, laughing, coughing.

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10 - Airborne microbial Challenge Test for pharma packaging integrity

Many references describe airborne microbial challenge test to evaluate the possible contamination of pharmaceutical packages due to improper filling or sealing. This Application Note intends to present the general Guide Lines as suggested by PDA.

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9 - Fungal Spore Control Ventilation (FSCV) in Hospital

The breathing of ambient concentration of airborne fungi for a normal person has no adverse effect on his health. The effects are adverse for the hospitalized patient with immune suppression: he is in fact susceptible to infections caused by naturally occurring airborne fungi that may grow at body temperature. The incidence of infections caused by fungi that were a few years ago considered only saprophytic has risen dramatically during the last decade.

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8 - Legionella protocol according CDC USA

Legionnaires’ disease was first recognised as a result of an outbreak of acute pneumonia that occurred at the Convention of the American Legion in Philadelphia USA in 1976. The route of infection has been recognised as the inhalation of small aerosol containing bacteria of the Legionella sp into the lungs of the host animal. The bacterium primarily responsible for this disease is Legionella pneumophila serogroup 1 Pontiac. It can result in typical Legionnaires’ disease an acute pneumonia with low attack rate and relatively high fatality rate or Pontiac fever, a mild non-pneumonia infection with a high attack rate.

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7 - Hands Monitoring in aseptic filling premises

The microenvironment of the skin is very restrictive, with little water, high levels of salt and a pH of around 5.6. Nevertheless, bacteria with adaptive properties colonize the hands, where they grow and constitute the normal resident flora. A transient flora may be temporarily tranferred from the environment onto the hands, from person to person and from person to objects.

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6 - Sampling Plan

The air sampling plan in check-list format aids both the operator’s supervisor and the operator in remembering all the points required for correct microbiological air sampling.

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5 - Bioaerosol Glossary

A ACGIH – American Conference of Governmental Industrial Hygienists, Inc. (USA) Action level – Established level of viable particles requiring immediate follow-up and corrective action and measures if exceeded. Aerosol – Colloid dispersed solid or liquid particles (biological o particulate) in a gaseous environment presentingnegligible gravitational setting.

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4 - Staff training for food handlers

The importance of mantaining good hygiene is well known to dairy and food quality control personnel, but it can be difficult to impress on general plant workers the importance of good manufacturing practice (G.M.P.). Increasing emphasis on general hygiene conditions will allow manufacturing of products with longer shelf-life, lower rejection rates, fewer complaints from customers, and higher production rates.

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3 - The use of Contact Plates for surface monitoring

Practical, readily available information on the efficacy of a sanitization procedure may be obtained by demonstrating its activity on a previously contaminated surface.

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2 - Microbiological Validation of Biohazard Cabinet and Laminar Flow Bench

Each laminar flow bench and Biohazard cabinet must be regularly tested and validated to control their performance. The purpose of the test is to identify breakage or irregularity of filters and/or alteration of the laminar flow with consequent turbulence and contaminated air introduced into the working area. The validation can be performed by company staff or entrusted to an external service organisation.

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