AES: You are using the Labguard 2 monitoring system, what kind of equipment do you monitor?

F.A.: “We monitor the temperature of three different kinds of equipment: incubators, refrigerators and deep freezers.”

AES: Why automatically monitor in real time?

F.A.: There are two very good reasons. The first one is the possibility to see all equipment temperatures at a glance and to be warned immediately by an alarm if something is wrong with one of them. And the monitoring is active 24 hours per day, so any malfunctioning of equipment during the night will be disclosed on the PC-screen placed in the laboratorium in the morning.”

The second reason is to gather all information for documentation purposes. The temperatures are automatically read and stored every 10 minutes. We also save time compared to manual reading since the laboratory is on the first floor, the refrigerators on the second floor and the deep freezers in the cellar”.

AES : What are the key parameters for your choice for the labguard 2 ?

F.A.: “It is very important for us to work in compliance with the 21 CFR Part 11. The new software version (Labguard 2) provides a complete documentation of all parameters. All data, like alarms or modifications are locked to ensure a full traceability. Print out of the temperature curves are done every month, we conduct a complete audit trail twice a year.”

Evaluation of the ScanRDI solid phase laser cytometer with the Coriolis cyclonic air sampler for real time microbial control of the air (Pfizer, St-Louis, USA)

AES CHEMUNEX and Bertin Technologies have developped a novel method enabling  the microbial air monitoring of clean rooms within 3 hours - from sampling to results

(pfizer USA  - Extrract from RMUG 2009 présentation)

"The Coriolis® system is an easy to use portable air sampler that collects air samples into liquid media. This allows quick icrobial detection when coupled with RMM technologies as demonstrated into this study.
The feasibility study conducted in Saint-Louis Micro Lab indicates that Coriolis® system collects airborne microorganisms in comparable amount to the impaction system does. ScanRDI can be used as Rapid Microbiology Method coupled with Coriolis® collection in order to give rapid results (around 3 hours from sampling to result). It is also shown here that the amount of microorganisms detected with the ScanRDI is higher than with the traditional method as far as it is not based on cultivability but on viability; appropriate alert and action limits may thus need to be re-evaluated for ScanRDI results. This couple of innovative methods fits for the Environmental Monitoring application and could be implemented for investigation and routine monitoring in production sites and in critical areas and cleanroom environments."

Pfizer study Team: Dr Lin Chen (responsible of the study), S. Fennell, W. Snapp

Download the Pfizer study on real-time microbial air monitoring

(first log in the customer area)

Click here to watch the video

 Gary Gresset, Alcon Laboratories, Inc

"The advantage of using ScanRDI for producing and releasing products as sterile, is the reduction in the incubation time in the existing compendial method which is 14 days. The ability to detect in a matter of hours what takes 14 days is a substantial economic savings.

The financial benefit to using a rapid method for sterility testing is the release the products that would have been in inventory for a long period of time, up to 14 days. The reduction in inventory combined with the reduction in the risk associated with products being made or realized to be sterile for a period of 14 days provide the insurance that you can release products within that day; they haven't been produced the day before; to reduce the risk and increase the financial benefit of your company.

The ChemScan can be used for more than just sterility testing, it can be used for bioburden in the examination and enumeration of in-process investigations, or further things you may need to make good decisions about your process, in terms of getting a one day product enumeration."

Ron Smith, Alcon Laboratories, Inc - extract from PDA 2009 presentation

"When routinely used, The ScanRDI requires neither lenghty incubation times nor specific culture media. However, by combining requirements of the reference sterility test with an MPN enumeration protocol we were able to directly compare the two approaches to sterility testing. The ScanRDI method for detection of microbes was demonstrated to be statistically non-inferior to the reference test and numerically superior in that it had a likehood of detecting microbes that was significantly greater at all diltution levels. As such, the ScanRDI method is appropriate for use as rapid alternative to the growth-based sterility test Method"

SPI Pharma validation of BactiFlow ALS (extract from Salles Propres)

"The performance qualification study performed at SPI PHARMA shows that the results obtained with the rapid technique using flow cytometry of BactiFlow are equivalent to the results obtained with the reference method.
The equivalence tests carried out over 6 months of production
showed a sensitivity equivalent to the reference method. In only one analysis, the implementation of this qualitative method allows to control the production within 24 hours, by also confirming the absence of the specific germs. In this precise case, the validation of this new approach showed that a qualitative test did not penalise to release the products compared to a quantitative analysis. The release of the finished products, thus validated in 24 hours, allows a reduction of the storage costs and an increase of the just in time production. In
addition, if BactiFlow is validated here within the framework of a qualitative analysis, it allows direct enumerations available for certain matrices according to their background. This aspect was used also at the time of this validation to estimate the stocks solutions necessary
to the inoculums preparation or to validate the neutralization
effectiveness and the control of the residual inhibiting capacity."

read more
 

GlaxoSmithKline Parma (Italy) manufacturing site has received inspection and formal approval from the FDA to use the ChemScan RDI scanning cytometer from AES CHEMUNEX, as a part of the rapid microbiological in-process monitoring of a non-sterile nasal spray product. Rapid monitoring of the manufacturing process using more sensitive tests allows accurate prediction of product quality; thus eliminating the need of final
product testing to release the prescription product to the market.

The recent work with the ChemScan RDI has delivered confidence in the speed and high sensitivity of the system to deliver accurate and early counts for the control of surfaces and product bulk solutions.
In addition to pharmaceutical waters testing, the sensitivity of the ChemScan RDI is used to deliver "real time" microbiological process controls for product bulk monitoring using bioburden application and surface monitoring using ChemSwab application.