HOSOKAWA ALPINE Aktiengesellschaft(细川阿尔派股份公司)商标

Isolators / containment

The development of increasingly active substances as well as the tightening-up of corporate and statutory regulations with regard to personal safety result in ever higher requirements to protect personnel from contact with these powdery active substances. To meet these requirements, a great variety of different systems has been developed over the last years which create a barrier between the operator and a possible dust exposure. We are talking here about so-called isolators, which constitute an enclosed housing around the process units where a dust exposure is considered likely. Processes realised with isolators include: 

  •  Sampling 
  •  Particle size analysis 
  •  Filling 
  •  Metering 
  •  Grinding/micronisation 
  •  System component cleaning 

 The integration of processing systems into isolators poses high engineering demands. When customising an isolator, the following points must be paid particular attention to: 

  •  Transfer port system concept 
  •  Operator-friendliness (ergonomics) 
  •  Product yield 
  •  Cleanability 

The isolator must be integrated into an existing product flow, meaning that special attention must be paid to the process steps upstream and downstream of the isolator. The method and shape of the feed or filling containers have a decisive influence on the transfer port concept. Dependent on the batch size or OEL, double-flap transfer ports (RTPs) or continuous liner systems are available. 

One of the greatest challenges when integrating processes into isolators is to ensure that the entire system can be operated comfortably, i.e. ergonomically. This simple statement puts extreme demands on the manufacturers of complex systems in terms of design of both the process components and of the isolators. 

After 3D-CAD modelling, a wooden mock-up is usually made which depicts the most important process sections and which serves to determine the final design. 

One advantage of integrating processes into a containment system is that the contaminated cubic volume is significantly reduced. After all, it is not the complete clean room with the associated interior that is contaminated but rather "only" the inside of a steel box. And to counter this, isolators are equipped with cleaning systems. These systems generally comprise ductings that taper into spray nozzles on the inside of the isolator. In addition, a spray pistol is used in most cases.

The know-how gathered by the Hosokawa Group in this field over the years has put Hosokawa Alpine in the position of being able to supply complete systems which considerably reduce the customer's planning and coordination complexity and which ensure reliable system operation. The realisation of numerous containment projects as well as the close cooperation with the customer highlight the competence and experience of Hosokawa Alpine on this sector.

  • Principle of operation

    Over the last years, the trend towards isolator technology has increased in the pharmaceuticals industry. In the case of process-technological applications such as the grinding or compaction of powders, protecting the operating personnel from active substances is a top priority. Isolators are employed in the implementation of high-containment applications. Practice has shown that every isolator must be adapted to suit not only the specific demands of a pharmaceutical product and its manufacturing process, but also the batch size and the technical environment in the production facility. In order to meet the requirements of a completely enclosed process configuration with a guaranteed OEL value, Hosokawa has refined the technologies already available on the market sector of isolators and containment systems.

  • Designs
    • High-end isolator: made of stainless steel with windows of safety glass, with safe-change filters in push-push design, with alpha/beta transfer systems, designed for WIP/CIP.
    • Glovebox: glovebox(es) made of, for example, acrylic glass with simple filter and transfer systems.
    • Flexible isolator: the isolator with flexible polymer skin and continuous tube transfer system. Developed in response to the demands for an inexpensive, flexible encapsulation of systems used for handling active materials in the laboratories of scientific research institutes or biotechnology and pharma companies, a flexible isolator offers excellent operator and product safety. The integration of processing systems into isolators puts high demands on the engineering, and when customising the isolator, the following aspects must be paid particular attention to:
    • Customer's product flow
    • Transfer port system concept
    • Operating comfort (ergonomics)
    • Process safety
    • Operator safety
    • Product yield
    • Cleanability
    • Control concept

    The isolator must be integrated into an existing product flow, meaning that special attention must be paid to the process steps upstream and downstream of the isolator. The type and shape of the feed or discharge containers have a decisive influence on the transfer port concept. Dependent on the batch size or OEL value, double-flap valve ports, RTPs or continuous liner systems are available. One of the greatest challenges when integrating processes into isolators is to ensure that the entire system can be operated comfortably, i.e. ergonomically. This simple statement puts extreme demands on the manufacturers of complex systems in terms of design of both the process components and the isolators.

  • Video

Contact:

Pharma & Lab Division
Tel. +49 821 5906-283
Fax: +49 821 5906-620
»  e-mail

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