Microbiology expert Oxoid has released a new active air quality monitoring device to help pharmaceutical companies prove that their clean areas are microbe free.
The compact and portable device uses impaction technology to sample the air and collect any microbiological particles on agar plates that, after overnight culturing, can reveal any breakdowns in a company's environmental control systems and procedures.
While some products can be sterilised at the end of the production process, many drug products are damaged during post sterilisation processes leading to those products needing to be manufactured in designated clean rooms.
Environmental monitoring of these areas is crucial as auditors can ask for records that prove the efficiency of the monitoring processes that have been put in place.
"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, Oxoid's pharmaceutical marketing manager.
"We are pleased 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."
In an interview, Smith explained the device would most likely be used in conjunction with a series of other monitoring techniques such as passive air sampling techniques like settle plates, surface sampling using contact plates or swabs and personnel monitoring.
Crucial to the devices use as part of a clean area environmental monitoring program is the calibration of the air intake with respect to recognised standards and a calibration certificate is supplied with the device.
Oxoid, part of Thermo Fisher Scientific, recommends that the device is recalibrated every six to twelve months and has a calibration service available to customers.
The instrument works by actively pulling air into the device through a series of small inlets which is directed at the surface of an agar plate. The device is light enough to carry and can be controlled either using the touchpad and screen or an infra-red remote.
The company claims that the sampler is 100 per cent efficient in collecting particles between 0.8 and 19 microns in size, and has had this validated by an independent laboratory to BS EN ISO 14698-1:2003 Annex B standards.