SubscribeWhen lives are at risk, there is no room for compromise. Isolators play a vital role when humans need to handle pharmaceuticals or pathogens
If the Ebola virus is identified anywhere in the world, identification will most probably take place in one of SKAN's isolators. These products are not just used for screening. SKAN is called in when a production-, freeze dryer- or a filling line for the latest pharmaceuticals and vaccines is being planned. Isolators are at the interface between an aseptic or aseptic/toxic zone and humans.
This is where pathogens are analyzed, trials are conducted and pharmaceuticals are produced or filled into containers. Isolators are essentially small Grade A clean rooms which comply with GMP/PIC guidelines. They provide an (aseptic) environment which has less than one particle with a diameter of 0.5 micrometer in 28.3 cubic feet of air. By way of comparison, normal unfiltered air has 25,000 particles.
Passing the toughest tests in the world
The material and functional characteristics of every part that is used in the production of isolators have to comply with very demanding quality criteria, namely the extremely stringent requirements of the pharmaceutical industry. These requirements are defined on regulatory basis in ISO standards US and EU Pharmacopeia and FDA guidelines, etc.
SKAN is familiar with the pharmaceutical business, they know what that means: Everything from top-grade stainless steel, safety glass up to sensors controlled by PLC according GAMP-IV is strictly high-tech! They cannot even rely in supplier certificates but need to perform internal tests on a sample basis to verify items such as welded-in sheet metal or software validation.
All SKAN systems are FDA compliant. The US Food and Drug Administration is the toughest test agency in the world when it comes to pharmaceutical production. Even the FDA references on SKAN`s decontamination process with hydrogen peroxide1) and the effect of carrier material on bio indicators2).
The Basle-based company has developed a (H2O2) hydrogen peroxide based decontamination system which is first fully embedded in the process and control flow and second effectively reduces micro organisms to the required level of a 10-6 contamination safety level. This decontamination method has now become a worldwide standard cited in the FDA guidelines.
Over- or negative- pressure is maintained in the isolators depending on the active ingredient which is being filled. Negative pressure is used for highly active, cytotoxic substance such as drugs used to combat cancer. This ensures that the active ingredients cannot be released to the outside even if the clean room area develops a leak. Overpressure is maintained in the isolator when aseptic and non-toxic active ingredients are being handled to prevent microbial contamination from the outside environment.
Reacting quickly to a pandemic risk
SKAN is currently building a filling line for a customer. The line is designed for syringes which are pre-filled with flue vaccine. Pre-sterilized syringes are transferred into the clean room area in sealed tubs, each with 100 pieces. Electron beams (E-Beam) decontaminate the surface of up to six tubs per minute transferred into the filling isolator. A small robot in the peeling zone of the isolator removes the cover foil. The vaccine is then filled into the syringes and sealed in a fraction of a second. When production is fully up and running, six tubs, 600 syringes will be filled every minute.
More than twelve of these Filling Lines have been installed by SKAN in Europe and they will be in operation for three shifts seven days a week, processing about five million pre-filled syringes a week. Once the WHO in Geneva has decided on the new flue vaccine formulation each year, the vaccine must be produced as quickly as possible to protect the world's population. If there is a risk of a pandemic, huge stocks of vaccine must be built up very quickly. All components and systems have to be working flawlessly to ensure that more than 20 million people around the world do not die (as happened. during the last pandemic, the Spanish Influenza, in 1918/1919).
For further information to:
- Sterility Testing Isolators ARIS- Cytotoxic Safety Isolators CSI with Rapid Transfer Hatch for Hospital applications
- Filling Line Isolators
- Lyophilizer Loading/Unloading Isolators
- Aspeptic and aspeptic/toxic applications
- Powder Handling Isolators
Contact:
SKAN Isolator Technology
P.O. Box, CH-4009 Basel, Switzerland
Phone +41 61 4 85 44 44, www.skan.ch
Publications:
- V. Sigwarth / Dr. C. Moirandat
"Development and Quantification of H2O2 Decontamination Cycles"
PDA Journal of Pharmaceutical Science and Technology,
Vol. 54, No. 4, July/August 2000. - V. Sigwarth / A. Stärk
"Effect of Carrier Materials on the resistance of Spores of Bacillus stearothermophilus to Gaseous Hydrogen Peroxide", Research article,
PDA Journal of Pharmaceutical Science and Technology
Vol. 57, No. 1, January/February 2003.