Valois steps up cleanroom productivity
to dramatically increase productivity as it dons the diving suit to
undertake environmental testing in its cleanrooms.
The contract manufacturer, who designs and makes pharma spray and dispensing systems, said it is the only company in its sector to have an in-house microbiology cleanroom for quality control purposes and the latest investments will enhance these capabilities even further.
The first investment is a new HIAC - a light extinction particle counter that is designed to count and measure very small particles - larger than three microns - on products after they are rinsed with purified water.
The particles are detected when they block out light, which causes a difference in potential - they are then analysed by 21 CFR part 11 software, which outputs a result expressed in numbers of particles for each designated size (between three and 400 microns).
"The HIAC lets us work faster and more productively than was possible with the conventional membrane filtration method," said Mickael Osmont, head of the microbiology lab.
"The older method will still also be retained, however, as it has the advantage of allowing the origin of detected particles to be determined, especially by comparing them with our library of known particles."
The firm's other new cleanroom addition is the VITEK 2 Compact, which can identify microorganisms using the characteristics of their phenotype.
It works by building a profile using an onboard spectrophotometer that analyses, in real time, the organism's response to 64 biochemical molecules.
After a few hours when the profile is complete, 21 CFR part 11 software compares it to a database and identifies the genus and the species.
"Qualification of the system has demonstrated that in eight out of ten cases the VITEK 2 gives a more reliable and accurate result than the conventional API manual system," said Osmont.
"In addition, the VITEK 2 cuts technician time to ten minutes per organism compared with 45 minutes using the older API method and total identification time is cut by a factor of six, increasing our bioburden testing turn-around time."
The time savings offered by the new investments will allow the firm to now identify more microorganisms than ever before and with this in mind, Osmont said that Valois is currently evaluating the possibility of routinely identifying all bacteria detected in its cleanrooms in order to be absolutely certain that no pathogens will harm its product quality.
