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53 - 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.

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50 - Ten suggestions to apply the Best Micro-Pipette Practice in microbiology

Equipment Care – Service every 8-12 months (Calibration, greasing parts, seals replacement, cleaning, disinfection, etc.). Tips – Replace tips every transfer (reused tips will carry extra organisms over the next sample). Aspiration Depth – Place tip just below the surface of the liquid (Too deep results in extra organism carry over on the outside of the tip). Slow, fluid motions – Do not allow pipette to “snap” up liquid into the tip (This creates air bubbles in the tip, and risk liquid entering the pipette shaft).

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48 - The Bluetooth applications to transfer data from the TRIO.BAS microbiological air sampler.

The Bluetooth applications is an ideal electronic device to transfer the environmental data collected by the TRIO.BAS air samplers.

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43 - Available microbial air samplers for airborne microorganisms.

The USP 38 – The United States Pharmacopeial Document – Official from May 1, 2015 – presents on page 1200 the list of the most commonly used tools for monitoring aseptic environments. SLIT-TO-AGAR AIR (STA) The unit is powered by an attached source of controllable vacuum. The air intake is obtained through a standardized slit below which is placed a slowly revolving Petri dish that contains a nutrient agar. Airborne particles that have sufficient mass impact the agar surface, and viable microorganisms are allowed to grow. A remote air intake is often used to minimize disturbance of unidirectional airflow.

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41 - Evaluation of different microbial air samplers

To evaluate different microbial air samplers it is useful to read what is written in the USP 38 of the US Pharmacopeial – official from May 1, 2015: “There are no standard methods for air sampling, and available literature indicates that air sampling methods are highly variable. It should not be assumed that similar sample volumes taken by different methods will produce similar rates of recovery.

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35 - 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

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32 - 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.

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30 - 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)

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24 - Record of results for microbial air sampling

The dispersion and diffusion of micro-organisms in indoor air is very irregular and influenced by several factors like the presence of air currents, number of people present in the environment, movement of people in the area, electrostatic charges, humidity, temperature, etc. It is clear the correct sampling technique is important. It is imperative to make several tests in the same place, at same time to produce a statistical result that takes an accurate picture of the microbiological conditions of the considered environment. To obtain a statistical result, it is imperative to have a correct record of all data of the sampling cycles.

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23 - Food Glossary according EFSA (European Food Safety Authorities)

An estimate of the amount of a substance in food or drinking water that can be consumed over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.

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22 - Microbial monitoring in closed environment: general suggestions

Viable particles are bacteria, yeast and moulds living microscopic organisms present in the air and on surfaces of the environment. Their testing usually includes the monitoring of – air, – surfaces, – staff. Viable air sampling Gravitational or settling Petri or Contact plates containing sterile growth media are used for sampling.

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15 - Trouble shooting in environmental monitoring

The major routes of contamination can be broadly classified as surfaces, water, people and air. Each time that “ALERT LEVEL” and “ACTION LEVEL” are reached, the person responsible for environmental monitoring should know what action must be taken. The reported troubleshooting guide taken from the Document Guide Line No.20 – Effective Microbiological Sampling of Food Processing Environments – by C. & C. gives some useful hints.

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