New particle counter 'longest lasting available'
airborne-particle counter with what it claims is the longest
lasting laser on the market, as well as new features that allow it
to calculate and create reports for EC GMP Annex #1, ISO 14644-1,
and FS-209E testing.
All drugs must be manufactured in accordance with current good manufacturing practice (cGMP) regulations which state that cleanroom validation must be performed and impose limitations for production environments.
The upgraded counter, Lasair II, has a comprehensive validation manual to meet the regulatory requirements of pharmaceutical manufacturers, making it easier to implement new technologies and both ISO and EC GMP reports are generated from a single sampling run.
Good automated manufacturing practice (GAMP) validation guidelines were used in the generation of the validation manual and it is completed with a simple to use iInstallation qualification/operational qualification (IQ/OQ) that can be performed on site by an end user. This closes the validation loop and makes the instrument very easy and quick to implement.
The latest proposed updates to the EU GMP Annex 1 have noted that stray light can interact with the particle counter causing false counts, and a change to legislation is being driven to account for this random counting variable.
In response, the Lasair II has a propriety light blockage device installed into the sample inlet that would allow a stroboscopic light to be placed directly above the sample inlet to no detriment to the counting ability of the particle counter.
Moreover, field data shows that less than 3 per cent of lasers fail within the first four years, projecting a laser mean time to failure (MTTF) of over 13 years and making the Lasair II, according to the company, the longest lasting particle counter available.
"Price is very moderate and falls right in the middle of current technology available," Mark Hallworth, pharmaceutical business manager of Particle Measuring Systems told In-PharmaTechnologist.com.
"It certainly is not the most expensive instrument in its class, although it defined the class."
Six years ago, the counter was introduced to the market with an internal algorithm that steps users through the Federal Standard FS209E cleanroom certification process.
This includes asking the operator to ensure that the box meets all the minimum demands for certification and rejects inputs that do not meet the standard, therefore providing a foolproof method of certification.
The instrument then issues a pass/fail printout with data on completion.
During the years of integrating the revised ISO14644-1 standard, the machine became invaluable for training new users in the standard expected as the Lasair II, again, rejected inputs that did not meet specifications.
Other instruments however require that a post performance calculation be made against a set of data, or that the data is managed off line.
The Lasair II also includes a USB port with can be used to download data or with a remote keyboard.
