N.55 – TRIO.BAS MINI Microbial Air Sampler Brief Illustrated Instructions

TRIO.BAS MINI Microbial Air Sampler Brief Illustrated Instructions 01 – The instrument: Air sampler with s/s aspirating head, battery charger. Sterile aspirating head (optional) 02 – Identify the plate 03 – Switch on the unit 04 – Programming: Select volume of air (if requested, operator name, place of sampling, plate identification) and confirm, pressing “GO” 05 – Remove the aspirating head 06 – Transfer […]

N.46 – Culture media and diluents – Selection of Growth Media in Cleanrooms, RABS, Isolator

Microbiology according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments -Page 1201, 1196. -Culture media and diluents The type of medium, liquid or solid, used for sampling or plating microorganisms depends on the procedures and equipment used. Any medium used should be evaluated for suitability for the intended purpose. The […]

N.45 – Identification of microbial isolates

Identification according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1201  A successful environmental control includes an appropriate level of identification of the flora obtained in sampling. A knowledge of the flora in controlled environments aids in determining the usual microflora anticipated  for the facility and in evaluating […]

N.44 – Environmental Microbial Data interpretation in aseptic processing.

We report what USP 38 – USP Pharmacopeial Conventions says at page1199 in the Chapter “Further considerations about data interpretation” of the document “Overall Management of a microbiological control program”. ZERO CONTAMINATION “In the high quality environments required for aseptic processing, detection frequency typically is low. As can be seen from the rates recommended in […]

N.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 […]