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The H2O2-resistant airborne microbial detection system for installation in isolators
The H2O2-resistant air microbial detection system for installation in isolators
Sterile isolators in the pharmaceutical and biotechnology industries are now mostly decontaminated using H2O2.
asip-compact is H2O2-resistant
Until now, a valve bypass circuit had to protect the respective air microbial sampler from the influence of H2O2 during the decontamination process. However, these bypass circuits often did not produce reproducible results in flow through the measurement lines. For this reason, asip-compact was designed to be H2O2-resistant. The existing vacuum unit ensures reproducible flow during measurement operation and during decontamination. Additionally, the entire measurement system is now flushed and decontaminated with H2O2. An elaborate decontamination circuit is no longer necessary.
Decontamination modes "active" and "passive"
asip-compact offers two decontamination modes. In the "active" mode, a configurable sample volume flows through the device (see image). In the "passive" mode, no flow is generated, and the control of asip-compact can additionally switch valves for a possible desired bypass.
Optimal hygiene design of the measurement points
The high standards for hygiene design are taken into account with the asip measurement heads and probes. For example, the asip impact measurement head can be completely detached from the probe with one hand and can be placed in existing device wash machines for cleaning. For sterilization, they can be treated with all conventional methods for microbial reduction. The probes carrying the respective measurement head are also removable and are cleanable and sterilizable.
Up to 2 measurement points can be operated on one asip-compact
Using the asip-switch2 measurement point switch, two measurement points can be operated alternately on an asip-compact.
Any number of asip-compact units can be networked
If multiple measurement points are needed within an isolator system, any number of asip-compact units can be interconnected.
With asip, the isolator chamber remains optimal for production use
The limited space within an isolator must of course be used optimally for the production process. The monitoring system that needs to oversee the process should therefore take up as little of the precious space as possible. It is important that only one probe with a measurement head is in the isolator. The actual sampler is installed outside the isolator.
The measurement system must not contaminate the cleanroom
This system setup meets another important criterion when choosing an air microbial measurement system. Such a device should not cause self-contamination, meaning it must not pollute the sterile production area through its own exhaust air. When using asip-compact, there is also the option to connect an exhaust filter.
The air balance remains balanced
This exhaust filter ensures that no particles are blown out of the device. The exhaust air can therefore be returned to the isolator on the raw air side. This prevents any pressure differential fluctuations in the isolator, as the air balance remains balanced.
Operation is controlled via the isolator control system
The existing isolator control system can manage the operation of the asip-compact systems. An additional control panel is therefore not required.
System boundary
The pharmaceutical-relevant functions of the asip-compact cannot be influenced by external controls. Therefore, an asip-compact system can be clearly separated for qualification purposes.
High flexibility in method and handling
asip-compact has been deliberately developed to be extremely flexible. It allows the user the freedom to adapt the measurement system to the existing, often long-established, sampling procedure.
Manufacturer: Hecht Automatisierungssysteme GmbH, Birkenstr. 2, 88285 Bodnegg
Tel. 0049-07520-924122
Technical Sales:
ppm GmbH Pharmaceutical Project Management and Monitoring Systems, Reinhold-Abele-Str. 16, 88289 Waldburg. Tel. 0049-07529-6199
www.luftkeimmessung.com
