Autoclaves from F. & M. Lautenschläger

QV-Compliance is partner with German F. & M. Lautenschläger GmbH & Co. KG, which is the oldest manufacturer of autoclaves, because they have a completely unique approach to quality.

At F. & M. Lautenschläger GmbH & Co. KG, all their autoclaves are specially made, and they are therefore used to delivering unique solutions to several different industries depending on specific requirements from the customers. We believe this is a big plus in terms of deliveries to GMP production, laboratories and Medical devices.

Validation package:

We can assist in qualification and validation of your new equipment. Our specialists have documented experience from design/requirement specification to performance qualification or process validation (URS, IQ, OQ, PQ and PV) with a science and risk-based approach.

We can work with templates within your quality system – or we can develop a customer specific solution.

Specialists in QV-Compliance A/S are familiar with best industry practices and are up to date with current regulation within the field and to the specific equipment.

We can help you with:

  • Define scope based on risk-analysis
  • Writing protocols
  • Planning and execution of tests
  • Deviation handling
  • Reporting
  • Management of the thermal validation activities

Lautenschläger steam sterilizers meet your individual requirements and follow the authorities requirements:

  • DIN 58951:2024-07
    (Sterilization –Steam sterilizers for laboratory sterilization items – Apparatus requirements, requirements on services and installation)
  • DIN 58950-2:2021-06
    (Sterilization – Steam sterilizers for pharmaceutical products – Part 2: Technical requirements)
  • EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
    (In the current version) Guide to Good Manufacturing Practice
  • Your URS, your factory standards….

The sterilizer chamber:

  • Calculation and design of the chamber and heating fins in accordance with PED 2014/68/EU, based on your requirements regarding materials, dimensions, chamber base gradient, working pressure and number of load cycles
  • Surfaces of the chamber, doors and chamber internals polished (<1.2 µm), or electropolished (< 0.8 µm). Other surface finishes (e.g. mirror polished) on request
  • Chamber connections as hygienic or aseptic flanges or clamps, in accordance with relevant DIN/EN standards or your factory standard
  • Loading height by arrangement at waist height, 30 cm above the floor or at floor level when installed in a floor pit

The quality:

  • Pipe classes according to relevant DIN/EN standards, e.g. DIN EN 11866 or according to your factory standard
  • Connections in the system or at the delivery limit as welding ends, hygienic or aseptic flanges or clamps, in accordance with the relevant DIN/EN standards or your factory standard
  • Drainable piping system, low dead space, e.g. 1.5 D, according to your requirements / factory standard
  • Gas-tight partition wall to maintain your cleanroom atmosphere
  • Cleanroom-compatible system front with hygiene locks and disinfectable surfaces

Contact and support:

If you have additional questions regarding Autoclaves or need technical support to your validation project, we will be glad to help you.

Send us an e-mail at info@qv-compliance.dk or call us at +4570707229.