Mecalab - Pharmaceutical Isolator Technology

Mecalab is a 100% daughter company of M.Braun Inertgas-Systeme GmbH in Munich. The M.Braun Group is owned by Indus Holding AG, Cologne, Germany.

Within the M.Braun group, Mecalab is specialized in the field of isolator technology with focus on the pharmaceutical industry and a worldwide network of representatives. Mecalab has successfully installed a wide range and number of isolators in research and production pharmaceutical companies, chemical companies, government labs, nuclear research centres, international reference labs, universities and research centres.

USER PROTECTION ISOLATORS

User protection isolators perform the following functions:

• Controlled negative pressure
• General gas flow towards the isolator
• Multiple filters on the gas exhaust
• Negative pressure transfer devices
• Closed cleaning system

PRODUCT PROTECTION ISOLATORS

This type of isolator ensures:

• Controlled positive pressure
• General gas flow towards the environment
• Positive pressure transfer devices
• Multiple inlet filters
• Closed cleaning system

STERILE ISOLATORS WITH H2O2 STERILIZATION

These isolators include the following functions:

• Special surface treatment
• Controlled positive pressure
• Combined with unidirectional flow (special laminar flow) and built in hepa-filters
• Independent sterilization of the isolator and the transfer devices

BIOSAFETY ISOLATORS

Biosafety isolators offer:

• Controlled negative pressure combined with unidirectional flow
• Integrated hepa-filters
• Safe change of the filter units
• Closed cleaning system

ISOLATORS WITH DEFINED ATMOSPHERIC CONDITIONS

These isolators offer the following control functions and can be adapted to include a combination of them:

• Inert gas
• Controlled CO2 concentration
• Oxygen and humidity control
• Temperature control

CONTAINMENT ISOLATORS

Containment isolators have been developed for high active compound and ensure:

• Constant, controlled pressure
• General gas flow towards the isolator
• Multiple filters on the gas outlet
• Negative pressure transfer devices
• Closed cleaning system

Mecalab can also manufacture combinations of the above isolator types to suit exact specifications and individual needs of each customer.

PRODUCT APPLICATIONS

The Mecalab product range serves in a large variety of applications. Some examples are:

• Synthesis of high active compounds (OEL level 4)
• Production of high active compounds with isolators on filter dryers, mills, mixers and tumblers
• Reactor filling
• Sterile isolators for sterility testing, sterile handling, production of medical devices, packing of medical devices and work with biological material (cross contamination)
• Safety isolators for handling of unknown compounds (biological activity, radioactivity, explosives etc.)
• Pharmaceutical production machines like capsule filling, syringe filling etc
• Sampling isolators on large production equipment
• Weighing isolators

All isolators ensure user protection, product protection and include containment isolators.

CUSTOMER SUPPORT

Mecalab offers engineering, planning and project support for isolators. We maintain the setup of your user requirements and specifications for isolators as well as with basic system layouts. As well as providing training for the users and technical supporters.

QUALIFICATION

In addition to the isolator hardware Mecalab supports your qualification efforts. All Mecalab isolators and production steps of the equipment are setup for full qualification following the GMP rules and the relevant norms. Mecalab provides the documentation needed and supports your qualification on site.