N.12 – Number of location and measurement for a reliable microbiological air testing

Introduction 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 […]

N.11 – Mycobacterium tuberculosis bioaerosol sampling

Introduction 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 […]

N.10 – Airborne microbial Challenge Test for pharma packaging integrity

Introduction 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.   Material and Equipments – Challenge Micro-organisms: Bacillus subtilis spores – Basic bacteriological laboratory equipment – Microbiological media – […]

N.9 – Fungal Spore Control Ventilation (FSCV) in Hospital

Introduction 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 […]

N.7 – Hands Monitoring in aseptic filling premises

Introduction 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 […]

N.6 – Sampling Plan

Introduction  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.     1. STAGE OF SAMPLING PLAN  ACTIONS AND COMMENTS  Date of sampling   Reason for sampling   Air Sampler Type   Accessories   table tripod   floor tripod […]

N.3 – The use of Contact Plates for surface monitoring

Introduction Practical, readily available information on the efficacy of a sanitization procedure may be obtained by demonstrating its activity on a previously contaminated surface.   The contact plates are easily used for this purpose to evaluate: A. If the general environment is adequately clean B. If plants and accessories are regularly sanitized C. The correct use […]

N.2 – Microbiological Validation of Biohazard Cabinet and Laminar Flow Bench

Introduction 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 […]