Isolator and climate chamber combined
When biopharmaceutical active ingredients are to be manufactured, the environmental parameters are crucial: even small changes in air temperature and humidity can have a major impact on the properties of the active ingredients. Weisstechnik has developed a special containment climate chamber for a pharmaceutical company and combined an isolator with a climate chamber to create a closed clean room. This ensures that, on the one hand, the operators are protected and, on the other, the product is always climate-controlled under sometimes extreme conditions. The solution enables precise control of humidity and temperature, which is crucial for the stability and effectiveness of the active ingredients. The isolator is integrated into the cleanroom and enables the safe handling and conditioning of active ingredients such as inhalants that need to be treated under extreme conditions.
Climate conditioning enables a stable particle morphology, which improves the bioavailability and efficacy of the active ingredients. The use of micronisation and conditioning techniques ensures that the particle size and chemical stability of the active ingredients are maintained. The system offers end-to-end process reliability, enabling complex biopharmaceutical products to be manufactured efficiently and safely.
For the first time, continuous clean room conditions have been created for the entire process of dispensing, conditioning and re-collection of the micronised active inhalation ingredient. The isolator is located inside the ISO class 7 cleanroom and is accessible to the operating personnel under sterile conditions. The isolator is embedded directly in the cleanroom wall, with an opening to the climate chamber permanently connected behind it. A self-sufficient air supply is connected to the climate chamber via a double HEPA filter. Both facilities, the climate test chamber and the air conditioning supply, are therefore not located inside the cleanroom, but in the technical room.
Laminar flow boxes as an alternative to an expensive cleanroom
It doesn't always have to be a complete cleanroom: The manufacturer Spetec currently offers the FBS series of laminar flow boxes for sterile packaging of pharmaceuticals and medical technology products. The devices are certified by the Fraunhofer Institute for Manufacturing Engineering and Automation in accordance with DIN EN ISO 14644 and categorised in class ISO 5. This means that a maximum of 3,520 particles per 1 square metre may be detected inside the box. This value is at least 10,000 times lower than in the ambient air. According to Spetec, this makes it possible to create highly effective cleanroom conditions at any workplace with a low investment outlay. The special feature is the GMP-compliant design made entirely of stainless steel.
Filter systems are the core elements of cleanroom
The cleanroom classes required for cleanrooms as well as laminar flow and isolator systems cannot be achieved without high-performance filters. One of the latest developments is the HET Micro filter system from HET Filter. This optimizes air filtration in sensitive environments, particularly in the pharmaceutical industry. The H13 and H14 HEPA filters are used here. The filter stages remove more than 99.95 % (H13) and 99.995 % (H14) of all particles from the air. HET has developed the so-called push-push technology to enable a quick filter change. This allows filters to be changed safely without interrupting the filtration processes. The filters are designed to achieve flow rates of 25 m³/h (H14) and 40 m³/h (H13).
The manufacturer Camfil has also developed the Cleanseal Exhaust Integrity air filter housing for use in cleanrooms in the pharmaceutical industry. The device has an integrated scan test facility with which the installed filters can be easily validated. The test probe covers the entire air flow during scanning and, according to the supplier, detects leaks much better than static validation methods. The aerosol application takes place directly on the housing and can be carried out both in the clean room and in the technical area. This exceeds the requirements of ISO 14644-3. The Cleanseal product family is flexibly scalable and therefore enables individual optimisation in terms of volume flow, energy efficiency or cleanroom class.
