ISOLATOR FOR ASEPTIC FILLING LINES
- These isolators can be installed in grade D rooms, according to EU-GMP standards.
- Equipped with a robust ventilation system, different stages of filtration and air treatment can be configured to tightly control pressure, temperature, humidity and particulates inside.
- The interior of the chamber is Grade A (ISO 5), with a laminar airflow with extraordinary homogeneity for perfect process protection.
- The design of the DWI isolator must be done in coordination with the manufacturer of the filler and/or freeze dryer, for a correct final coupling between all of them.
- Different air locks will allow us to solve all the casuistry that we are faced with.
The integrated low-temperature disinfection system using H2O2, developed by LITEK Pharma, enables robust and fast disinfection cycles to be carried out inside the isolator.
ATMP ISOLATOR - ADVANCED THERAPIES
There is a challenge in today’s advanced therapy environment, which is to get your preparations done in a safe environment.
At LITEK PHARMA, we have prepared various solutions to enable these production processes to be carried out in a safe aseptic environment,
inside the isolator. Compared to traditional clean rooms or laminar flow booths, we offer solutions integrated in isolators for the highest
guarantee of process sterility.
CONTAINMENT ISOLATOR
LITEK PHARMA isolators cover a wide range of containment applications whose mission is to create a safe environment for operators. Operator safety is crucial due to the toxic nature of the products handled inside.
These isolators make it possible to handle high-potent or highly active products (HAPI), with absolute guarantee for the safety of the operators. Prepared and validated up to OEL5 (≤50ng/m3).
STERILITY TEST ISOLATOR
Litek Pharma’s expertise covers isolators for sterility testing, isolators for small scale filling systems as well as for large industrial scale customised systems.