Biotest HYCON

NEW SLETTER No. 74 March 2007

Biotest has improved his RCS High Flow again and reacts to the current requirements of his customers working in microbial monitoring. However the excellent sampling efficiencies of this instrument using the most safe and effective technology centrifugal impaction - remain unaffected. The important changes are:

- RCS HIGH Flow with new graphic display and wireless data communication

1. New graphic display The new display will replace the old one suffering by the low resolution. The new high resolution will provide very good readability and the possibility to use graphic pictures. By that the instrument is using the well known In-Vitro-Diagnostic symbols to give quickly important information without any misunderstanding. Furthermore the display will give more information on one view, for example the total serial number of the active rotor and the according expiry date of its calibration. That means the user is always informed about all important facts during the sampling process. This avoids uncertainties and at least - costs.

2. Service Menu Using the new display possibilities a new Service Menu was developed, which allows a self explaining one-hand-operation for all important settings for delay-time, defined sample volumes, intervalsampling, calibration factor and time. Less handlings steps will safe time and provide more security during the operation process. On the other hand the routine handling steps (rotor selection volume selection start) remain unchanged. That means no extra training is needed for current customers to use the instrument in the routine. 3. Wireless Data communication Future orientated the RCS High Flow has now the option to communicate wireless. In the position as interface between both a barcode scanner and personal computer the air sampler can import data from a barcode scanner, add his own sampling information and export the data file to an external personal computer. In combination with a complete set for wireless data communication (Biotest HYCON-ID, art.no. 940 360), the user can document error free all important sampling information (e.g. individual sampling number, location, username, agar media, air sampler, sample volume and others) within some seconds. This revolution of data collection will safe a lot of time and money and provides the most secure system.

4. Sampling efficiencies Because all sampling affecting parts remain unchanged, same excellent sampling efficiencies as documented in the Validation Handbook (art.no. 940 120) are still valid.

Summary of the Validation results acc. ISO 14698 (Biocontamination Control):

1. 2. 3. 4. 5. The 100 % Physical sampling efficiency for was found for particle sizes from up of 3-4 m diameter Lowest detection limit: 0.4 0.6 m particle diameter Impaction speed: 7,0 m/sec (particles of 10 m diameter) The Biologic sampling efficiency (active airsampling) was found for all test strains at 58-91% (in comparison Impinger: 43-94%). Gently collection process! Detection of gram negative microorganisms (E.coli) on MacConkey agar after active air sampling demonstrated!

5. Other important features a) Usage in highest cleanroom classification (e.g. Isolators) by complete disinfection with hydrogen peroxide vapour. No distribution of contaminating particles! b) Less risk of turbulences by directed air stream. No false low or negative results! c) Easy handling by low weight d) NIST- or PDB traceable calibration (GMP demand) e) Full list of different agar media (unselective, selective, special), including the best unselective media TCI-, which is capable to neutralize up to 5000 ppm peroxide traces in isolators (patented) and avoids wrong negative results. Demanded by guidelines and norms. f) Monitoring and warning of calibration expirations. g) Possibility of blocking functions of the instrument (via incl. RCS Management software) to avoid unauthorized changes of rotor selection and volume setting. h) Independence of power supply by using rechargeable batteries. h) Manually and automatically switch-off function. The complete set of the RCS High Flow (art. no. 940 216) includes:

- RCS High Flow - Rotor - 2 rechargeable batteries - Serial cable - CD-ROM (RCS Management Software) - Manual and Certificate of Calibration

VF-Biotest HYCON

Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Telefon (0 61 03) 8 01-0 Fax (0 61 03) 8 01-1 40