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上海市沈砖公路6000号 C1-206室

电话:+86 (0) 21 6019 0256

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Quality performance

Product related activities:
  • Development.
  • Design.
  • Production of series products.
  • Production of custom products.
  • Application and technical advice.
Additional services:
  • Installation and start-up.
  • Special technical developments.
  • Tests and process development.
  • Individual service on-call.
  • Contract service.
  • Qualification and validation.
  • GMP-compliant documentation.
  • Consultancy on sterilization processes and special requirements.
  • Process development.

Qualification and validation

Within the scope of our service we offer you qualification and validation work with GMP-compliant documentation:

  • DQ – Design Qualification
    – Definition of requirements regarding the autoclave with respect to process technology.
  • IQ – Installation Qualification
    – The autoclave is manufactured and installed according to the defined DQ requirements.
  • OQ – Operation Qualification
    – The autoclave to function as specified in DQ.
  • PQ – Performance Qualification
    – The autoclave sterilizes the product permanently according to pre-defined specifications.

Quality Assurance according to ISO 9001

Our Quality Management is such that it complies with the most stringent requirements of testing and documentation.

Each component is subject to exhaustive control and each autoclave is checked and tested for all functions before delivery. A Certificate of Acceptance is provided.

Additional features and programs

For example for the food industry for the sterilization of liquids in closed vessels, plastic bottles, bags, cans, blister packs and food packs, e.g.:

  • Devices and programs for sterilization in a steam / air mixture.
  • Devices and programs for sterilization with hot water spraying and spray-cooling.

Custom constructions for individual tasks

Development and construction of modified systems such as:

  • Autoclaves in dual system.
  • Autoclaves for waste water sterilization (flow-through principle with integrated stirring and high-performance heating elements).
  • Autoclaves for the sterilization of hand-wash water.
  • Autoclaves for environmental simulation with programs for up to 99 days of testing, e.g. for:
    - Generation of steam and heat.
    - Generation of pressure and heat.
    - Heating up and cooling down in repetitive mode.

Detailed information on customized design available on request.

Test autoclaves are at your disposal in our test laboratory for the evaluation of your process parameters.