Lab professionals that need an aseptic environment to conduct sterility tests of the pharmaceutical products find the relevant Sterility Testing Isolators, e.g. the Sterility Testing Isolators Canada to be of great use. The isolator system is made up with Pre-Chamber and glove chamber wherein the former can be utilized as a fast grassing port. Other things that can be fixed at later stages include a group of sensors, feasible / non-feasible counting, sterility testing systems, fast transfer port / ports and additional chamber / chambers etc.
A unidirectional air flow works well with the system and is advantageous for facilitating viable pressure for the lab environment. White Silicon Bio-Guardian® is used to make the inflatable and still seals. The anti bacteria inhibitors prevent the development of micro organisms. The 12mm tempered glass laminated with a safety film is used to make the view panels. Predisposed adjustable ergonomic stool is there for the operator to operate the system in a viable manner. He or she works better with the system that is capable to ensure process integrity. The Isolator enclosure remains free from waste materials.
This unique system is beneficial in terms of finance as it saves the clients that possess limited laboratory space. It benefits them in terms of fast decontamination too.
Varied Uses – The Sterility Testing Isolators are used as interface isolators, sterility testing, transfer isolators, powder charging/handling isolators and filling machine isolators etc.
Sterility Test Isolators are utilized for elimination of false positives while the testing process is going on.
The interface isolators are fixed directly to a projection on the equipment door that is interfaced, e.g. lyophilizer or depyrogenationoven or the autoclave. Usually a half-suit is utilized by the isolator because of the size of the equipment chamber and the inside load to enable the operator to access the equipment and the loading cart.
The products or the components from one isolator to the other are transferred by using the Transfer Isolators that is done with the use of RTP system. These isolators being mobile in nature generally comprise of shelves to store the materials that are often loaded in them, followed by decontamination prior to transfer.
Filling machine isolators work better with continuous filling systems or the batch filling and are highly customized. These isolators can be designed for incorporation of the bench top fillers or interfacing directly with a large sized machine table top.
It may be noted that the unidirectional flow with the help of HEPA filters is a must along with a feasible overpressure system. Usually a negative pressure breach system is employed for aseptic fill of the possible radiopharmaceuticals or the potent liquids.
Advantages – Use of the Sterility Testing Isolators benefits the users as under:
a. The persons that possess these unique isolators save their money as these systems consume less energy.
b. The design of these systems falls in line with EU GMP.
c. Each chamber is equipped with varied pressure regimes
d. Process separation is quite convenient.
e. The large oval PharmaPort gloveports (safe change) and sloping operator interface panels are a matter of great convenience for all.
f. Complete process tools mixing within the grade ISO 5 environment
g. Turbulent airflow systems or the Recirculation laminar flow airflow system are compatible with the ISO 5 classification
h. Inclusion of the Sartorius Sterisart®NF or Integrated Millipore Steritest® Unit is much advantageous.
i. The system itself is designed to fall in line with the limited lab space.
j. Tailored storage and racking, suitable for all applications.
k. In-built Hydrogen Peroxide Decontamination.
Different uses of the Sterility Test Isolators have increased their demand across the globe. The people engaged in testing fields related to the pharmaceutical equipments find these isolators of great advantage and importance.
