SINGLE-CHAMBER ISOLATOR FOR STERILITY TESTING OF MEDICINES

REATORG completed a turnkey project for the supply of a sterility testing isolator for a pharmaceutical production quality control laboratory.

As part of the task set by the Customer, REATORG completed a project that included the following stages:
1. Development of URS and design of the isolator (it was supposed to mount the isolator in cramped conditions);
2. Supply (delivery and customs clearance);
3. Installation and commissioning;
4. Qualification of the isolator;
5. Validation of the decontamination process using chemical and biological indicators.

Tailin Bioengineering Sterility Test Isolator is made of 316 L stainless steel, equipped with an airspeed sensor, temperature/humidity sensors, pressure sensor, built-in hydrogen peroxide generator for decontamination of the chamber and loaded surfaces, glove integrity tester, and built-in HTY system -602A for testing drugs for sterility using special Steritailin® Sterility test kits. The isolator has ports for connecting an isokinetic sampler of an external particle counter and an air sampler for checking it for microbiological purity.

To monitor the decontamination cycle, a high hydrogen peroxide concentration sensor was installed, according to which readings the decontamination cycle time is counted. To ensure the safety of personnel, a low concentration sensor was installed, which indicates the residual amount of hydrogen peroxide in the chamber after ventilation of the chamber at the end of the decontamination process.

The complexity of the project was the need to install the isolator in a limited space. The dimensions of the room differed from the dimensions of the isolator by only a few centimeters. Disassembling the walls of the room and doorways was impossible. To carry out the installation in space-limited conditions, REATORG's engineers in cooperation with colleagues from Tailin made a scheme for disassembling the insulator into 6 parts, and the assembly was carried out on-site using a specially designed mounting frame.

Upon completion of the installation, pre-commissioning, IQ / OQ qualification, and validation of the decontamination process using chemical and biological indicators were carried out.