Cleanroom Microbial Monitoring with the BioCapt Single-Use (BCSU)

In crucial areas, the majority of the recent regulations promote the use of continuous viable air monitoring. The BioCapt^® Single-Use (BCSU) Cleanroom Microbial Monitor by Particle Measuring Systems (PMS) is an active sampling technique that is superior to the usage of settle plates and creates validated and actionable data.

The BioCapt Single-Use helps reduce microbial false positives in monitored clean areas by decreasing contamination from the handling of agar-settle plates. This leads to a decrease in examinations and a rise in productivity.

Several expensive and laborious sterilization steps, like disinfecting, autoclaving, handling, and logistics are also removed. This new method to viable microbial air sampling and monitoring relies on the collection efficiencies of the BioCapt stainless steel viable impactor, while also removing false positivesfrom handling via single-use applications and specialized packaging.

The BioCapt Microbial Impactor (Single-Use) obtains sampling with the least amount of air disruption and can be utilized to sample efficiently from 25 to 50 L/minute (LPM) to fit both fast sampling needs and routine monitoring.

The 25 LPM device retains and recovers microorganisms under stressed conditions following two hours of continuous air sampling. Hence, the number of plate changes needed for continuous air sampling has been reduced. Users can learn more about this continuous air sampling solution.

The 100 LPM BCSU has been released most recently to meet the requirements from the market for troubleshooting and analytical applications. Also, it utilizes the same innovative radial slit design as the 25 and 50 LPM models, thereby sharing the benefits of the well-known and trusted single-use technology.

It is being validated at the Centre for Applied Microbiology & Research (CAMR), a Health Protection Agency (HPA) at Porton Down. It obtains isokinetic sampling for the least air turbulence in accordance with ISO 14698-1 and can be utilized for sampling and troubleshooting at 100 LPM.

BioCapt^® Single-Use Cleanroom Microbial Monitor

If users are presently using a standard stainless steel remote atrium, the BioCapt Single-Use is a handy alternative. Users can just pull off the cap and insert the disposable atrium into their vacuum source. Also, they can remove the lid and begin sampling.

Once the sampling is done, the cap can be placed back and the plate can be incubated. Particle Measuring Systems make viable air sampling very simple. The disposable samplers have been filled with agar, gamma-irradiatedand are ready to use. Users can store these from 2 to 25 °C with a shelf-life of 12 months from manufacture. It does not get much simpler than this.

BioCapt Single Use Microbial Impactor from Particle Measuring Systems: Simple to UsePlay

Video Credit: Particle Measuring Systems

Features

ISO 14698-1 compliance

Fulfills GMP Annex 1, rev 12 single-use needs

Compatible with first in class active air monitoring systems

Validated culture media is stored at room temperature or under refrigeration. This has a shelf life of up to nine months for viable monitoring

Provided in standard culture media of sabouraud dextros agar (SDA) and trypticase soy agar (TSA), as well as client-specific, pre-validated microbiological culture media

Settle plates in cleanrooms are replaced

Use as part of a data integrity program

Plates with a flow rate of 100 LPM in accordance with the MiniCapt^® Mobile

Decreases the risk of spills that results in contamination

Benefits

Helps remove false positives by decreasing the risk of contamination by improper handling of media plates

Streamlined standard operating procedures remove possible injuries and handling concerns with stainless-steel impactors

Removes laborious and operator-dependent cleaning and process steps linked to conventional stainless steel microbiological samplers, such as sanitization, disinfection, sterilizationand autoclaving procedures

Decreases risk at the time of the introduction and removal of microbiological sampling plates in sterile production areas

Applications

Constant viable air monitoring

Viable microbial air sampling in cleanrooms and linked controlled surroundings

Bioburden tracking of medical device manufacturing environments

Microbial monitoring of aseptic manufacturing regions

Microbiological monitoring of surgical suites or operating rooms

Use with MiniCapt^® Mobile for an entirely validated solution

USP 797 environmental viable airborne particle testing can be done

Family of BioCapt and MiniCapt products available that offer flexible monitoring options for isolators and other new applications such as troubleshooting