THE MICROBIOLOGY LABORATORY: More, More & Always More!
Valois has recently equipped with two new cutting-edge systems. The aim: to raise its expertise to an even higher level.
22/09/06 Already the only company in its sector to have its own in-house microbiology laboratory, Valois has recently equipped with two new cutting-edge systems. The aim: to raise its expertise to an even higher level.
Mickael Osmont has a smile on his face. He is not a little proud of the impression made on visitors by the microbiology laboratory he heads up. Here, in the heart of Valois' Le Vaudreuil plant, he and his team relentlessly track down the slightest trace of bacteria, the smallest particle that might contaminate the company's clean rooms or products. “None of our competitors has a laboratory like this” he says, his gaze sweeping over the equipment he now has available.
Environmental tests
“This here is a laser counter for particles in the air and a biocollector to measure numbers of bacteria. We use these to carry out environmental tests in our clean rooms. Every month, we inspect all 90 assembly machines installed in the plant. It is a full-time job for one of our technicians”. With copious explanations on how his many items of equipment work and their high performance, Mickael carries us along in his wake.
Bioburden tests
“Here, we carry out bioburden tests on the components, finished and semi-finished products that come out of our machines. We dip and agitate the parts in a special fluid (fluid A recommended by the European Pharmacopoeia). We then filter the fluid through a 0.45 micron membrane which will trap all the microorganisms present. We apply two types of filtration: one is used to culture bacteria and the other yeasts and moulds. After incubation, we count the colonies which we then proceed to identify”.
Particle tests
Enthusiastically, Mickael now takes us to an impressive binocular microscope. “We use this for the particle tests. After filtration through a membrane, we carry out an automated particle count using a digital camera controlled by a motorized unit and coupled to software which counts and measures the particles using contrast differences with the membrane surface”.
As if that wasn't enough…
All this apparatus enables Valois to apply a whole battery of microbiological tests that go far beyond what is demanded even in the United States by the notoriously difficult to please FDA. When all is said and done, if the company was not determined to offer its customers the best level of service and the best possible assurances of safety, it could do without an in-house laboratory. However, Valois attaches great importance to the quality of its services as the foundation for its position as a global leader. Not only is Valois not content with having its own cutting-edge laboratory, but it also wants to enhance the laboratory's expertise still further. The proof? Valois has just made two major investments.
The HIAC: a light extinction particle counter
Mickael is already standing beside the first of those investments, the HIAC, explaining; “This is a system perfectly designed to count and measure very small particles - larger than 3 microns - on our products after rinsing with purified water. The particles are detected when they block out light, which causes a difference in potential. This is then analyzed by 21 CFR part 11 software * which outputs a result expressed in numbers of particles for each designated size (between 3 and 400 microns). The HIAC lets us work faster and more productively than was possible with the conventional membrane filtration method. But that being said, the older method will be retained because it has the advantage of allowing the origin of detected particles to be determined, especially by comparing them with our library of known particles”. What is highly surprising is that this is not a new development at Valois. The team has been in the habit of photographing at different magnifications any even slightly unusual particle they come across. You can see displayed on the wall pictures of particles of wool fiber, a red hair, cardboard fiber, and talc, for example.
The VITEK 2 Compact, an automated microorganism identification system
Mickael drags us away from the particle library and takes us toward the second investment. Brand spanking new, this is the VITEK 2 Compact and it “identifies microorganisms using the characteristics of their phenotype. What it in fact does is build a profile using an onboard spectrophotometer that analyzes in real time the organism's response to 64 biochemical molecules. When the profile is complete, which takes a few hours, 21 CFR part 11 software compares it to a database, and then announces the genus and the species. In addition to the precision, repeatability and robustness of this device, qualification of the system has demonstrated above all that in 8 out of 10 cases the VITEK 2 gives a more reliable and accurate result than the con-ventional API manual system”.
“While we are on the subject of the VITEK/API comparison, total identification time is cut by a factor of 6, and this should make our bioburden testing even faster. And since the ultimate purpose of the investment is naturally to increase productivity, the VITEK 2 cuts 'technician time' to 10 minutes per organism compared with 45 minutes using the older API method”. Mickael adds: “This time saving will of course be used to identify more microorganisms and I am currently looking at the possibility of identifying all bacteria detected in our clean rooms as a routine procedure in order to be absolutely certain that no pathogens will harm our product quality”. Offering valuable time savings as it does, the Vitek 2 Compact also highlights the fast reactions of Valois. The device comes from Biomérieux and arrived on the market only at the end of 2005. Valois was the tenth purchaser - and the fifth to validate its use in France.
