Oxoid launches robust automatic air sampler
Oxoid, part of Thermo Fisher Scientific Inc., has launched a robust, high specification air sampler designed to monitor microbiological air quality in controlled environments, using proven impaction technology.
The Oxoid Air Sampler is compact and easily portable, making it suitable for monitoring wherever aseptic operations are performed, including:
- cleanrooms
- isolator units*
- manufacturing and filling areas
- gowning rooms and other support areas.
A simple keypad menu (in a choice of languages) leads the user through a variety of preset or user-defined functions, including flexible sampling volumes, delayed start, multiple run and variable interval options. It can be operated manually or using an infra-red remote control, enabling its use in highly sensitive, closed environments.
Validation studies have demonstrated a physical efficiency of 100% for particles 0.8 to 19.0 µm in size (BS EN ISO 14698-1:2003 Annex B).
Once activated, the unit automatically samples air at a fixed rate of 100 litres per minute. Air is drawn through small holes in the sample head and directed onto the surface of an agar plate. A flashing LED shows that sampling is in progress and an audible signal indicates the end of the sampling period. The agar plate is then removed and incubated to assess levels of contamination.
The Oxoid Air Sampler can accommodate 55mm and 90mm plates and has flexible plate holders that allow for slight variation in plate diameter. The unit is supplied with a 90mm sampling head as standard, with a 55mm sampling head available as an optional accessory.
Sample details (e.g. date, time, location, sampled volume and operator ID) are stored within the unit. The data is easily accessed and visualised on the alpha-numeric display or can be printed via a standard printer cable. It can also be downloaded to a computer for reporting and trend analysis.
The information obtained using the Oxoid Air Sampler can be used to support regulatory requirements, such as those outlined in the MHRA (Medicines and Healthcare products Regulatory Agency) Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 ‘Orange Guide’, and to ensure that levels of air-borne micro-organisms fall within accepted in-house limits.
The Oxoid Air Sampler is supplied fully calibrated with a calibration certificate traceable to recognised Standards. Furthermore, the sample head can be changed, or removed for cleaning, quickly and easily without the need for recalibration. Calibration is recommended at six to twelve monthly intervals after purchase, and can be carried out using Oxoid’s calibration service.
“We appreciate how important it is for pharmaceutical and medical device manufacturers to be able to demonstrate microbiological control within critical areas,” said Alison Smith, pharmaceutical marketing manager. “We are pleased, therefore, to add this robust and reliable air sampling system to the wide range of Oxoid environmental monitoring products that are designed to help manufacturers ensure the safety and quality of their products.”
Oxoid provides a full range of pre-poured plates for use with the Oxoid Air Sampler, including Tryptone Soya Agar and Sabouraud Dextrose Agar in 90mm and 55mm contact plate formats. These can be supplied irradiated and triple wrapped (including VHP impermeable packaging) as required.