CILAG chose an automated density measurement system from METTLER TOLEDO: the DE51- SC30 combination.
Online PR News – 20-November-2009 – – CILAG is a Swiss pharmaceutical and fine chemicals company. It is part of the Johnson & Johnson Corporation and has very successfully expanded its activities in the recent past. Among other things, it produces cartridges for a sterilization system, which is used by medical professionals for low temperature instrument and medical material sterilization. It uses hydrogen peroxide vapor and low temperature plasma and is particularly suited to heat-sensitive and moisture-sensitive instruments.
For this process, hydrogen peroxide has to be accurately dispensed from plastic ampoules. CILAG manufactures these ampoules and, as part of final quality control, has to determine hydrogen peroxide concentration as well as the ampoules’ filling volume. Both processes involve measuring density: Hydrogen peroxide concentration can be derived from density measurement while density and fill weight serve to calculate fill volume. Density measurement is therefore key to the quality control of sterilization ampoules.
“We have very tight specifications and therefore needed a highly accurate density instrument,” says Mr. Satzinger, quality control manager at CILAG. “We previously experienced problems meeting these specifications with a manual, stand-alone instrument as hydrogen peroxide tends to degas and form bubbles when filling the cell with a syringe.”
To overcome these challenges, CILAG chose an automated density measurement system from METTLER TOLEDO: the DE51- SC30 combination. Now, it is only necessary to open the plastic ampoule and place it in a sample vial on the sample changer. The instrument does everything else. It returns the sample to the ampoule after each test, which is particularly helpful if the sample needs to be remeasured. “The standardized filling, cleaning and drying sequence helps to avoid errors due to gas bubbles and ensures that every sample is treated exactly the same,” said Mr. Satzinger.
“We only analyze six samples per day,” added Mr. Satzinger, referring to the workload of the system, indicating that reasons other than productivity improvement were important when the top-of-the-line automated system was selected for the analysis of hydrogen peroxide concentration in a sterilization product.
With tight specifications and multiple operators using the equipment, automation ensures that results are always reliable. CILAG had another strong reason to opt for an automated system: The hydrogen peroxide in sterilization ampoules is very concentrated. It can be dangerous when in contact with skin and particularly with eyes.
“We have very rigid internal health and safety guidelines and do everything we can to protect our staff. Thanks to the automated system we feel much safer, as manual interaction with the product has stopped almost completely”, continued Mr. Satzinger.
For CILAGs, accuracy and repeatability as well as concerns for operator safety easily justified their investment into an automated DE51-SC30 density measurement system.