Service

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The core issue or our range of services is to upgrade your aged technologies or to repair your defective devices in the shortest time in order to minimize downtime and thus save costs. This motto presents the minimalization of standing periods of your production – from reliable engineering during the planning phase, via start up or maintenance of the production plant, up to service works on a running bioreactor plant.

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Please find an overview of our service offers below

• calibration, recalibration and validation support
• service e.g. for fermenters, autoclaves, mixing systems, temperature control system (independent of the manufacturer)
• on-site-repair
• general overhaul
• performance of annual maintenance according to your specifications or our recommendations
• fastest procurement of spare parts (Please also see our EShop)
• user training
• technical consulting
• installation and briefing

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Bioreactor Engineering by bbi-biotech

Our engineers have years of experience in the biotechnology equipment industry, especially in planning, manufacturing, procurement and development of bioreactor systems.

We will support you in all questions concerning process engineering of fermenters or bioreactors, as well as well as the whole biotechnological Production, including the following:

• extension or modification of existing fermenter systems
• engineering (support in planning your new production and research plant, P&I-drawings, 3D-models)
• technical consulting
• qualification of your system
• selection of applicable cultivation technique
• determination and procurement of the necessary equipment
• optimization of your process, in especially for continous and perfusion processes
• planning of your process (instrumentation/system design)

Qualification & Validation

m and devices. bbi-biotech assists you in all aspects of qualification of your system and validation of your processes from the beginning of all engineering tasks. We support the start-up of your installation with the delivery of required documentation and we give our support during the communication with the certifying authorities.

These include e.g.:

Installation Qualification

The IQ is the documented verification that all key aspects of the installation adhere to appropriate codes and approved design intentions, and that the recommendations of the manufacturer have been suitably considered.

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Operation Qualification

The OQ is the documented verification that the equipment related system or subsystem performs as specified throughout representative or anticipated operating range or meets the properties described in the specification document.

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FAT – Factory Acceptance Test

The FAT is the acceptance of the sytem by the customer at the manufacturer site. Among other things, the funcionality of the machine/device, the completeness of the documentation, the spare part list and certificates are checked at the place of production.

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SAT – Site Acceptance Test

The SAT is the acceptance of the sytem at customer’s site: Among other things, the funcionality of the machine/device, the completeness of the documentation, the spare part list and certificates are checked on site or after transportation.

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Calibration of sensors and measuring instruments

Quality of sensor signals have direct influence on product quality within automated processes. Even sensors which are meant to be simple systems like temperature or pressure sensors may vary due to aging processes. Those small variances may have big influences, even if in most cases the sensor itself still works fine, just with slight range variations. bbi-biotech provides the technology for calibration of the most common sensor types (e.g. pH, t, pO2, turbidity, etc.) and refits your sensors and analytical instruments to the desired reliablity. bbi-biotech and especially our service technicians have many years of experience in this area and have a big archive of necessary test documents on their disposal.

Lectures & Training

The biotechnology sectors develops fast. Take profit from the longterm experience of our staff and strain yourselves or your personnel with chosen knowledge from the wide field of biotechnology or touching technologies.

We introduce you to the basics or selected details of biotechological production or we concentrate on issues of measuring and control technologies – please choose your preferred topic from the proposed list below. We will be happy to adapt the content to your personal requirements.

• general introduction in bioreactor technics
• bioreactor types
• advantages and disadvantages, basic conditions
• PAT – Process Analytical Technologies
• What is the aim of the FDA (Food and Drug Administration)?
• measurement and control engineering at bioreactors
• new sensors, online, offline and atline analytics
• methods of continuous and perfusion fermentation
• introduction in process control and data acquisition systems
• documentation and regulatory basics of the cultivation in bioreactors
• process optimization of production lines (plant design)
• approaches in process optimization
• economic evaluation of new, disposable cultivation systems

Please note: At the moment lectures are only held in Germany. Please contact us for details or to discuss other training topics from the whole biotechnology and fermentation sector.