LITRONIK Batterietechnologie GmbH Lithium-iodine and lithium-manganese dioxide batteries and battery packs for active medtech implants
Profile
LITRONIK is one of the few suppliers of compact, ultra reliable primary batteries for active implants anywhere in the world. Since 1990 the company has developed and manufactured these high-performance energy sources in a variety of performance ranges, and they feature, among other things, very high volumetric energy and power densities, rate optimisation, low self-discharge rates and high operating safety.
LITRONIK supplies customer-specific solutions as well as standard products to a variety of manufacturers of pacemakers, defibrillators and neurostimulators, both within and outside of Europe.
The electrochemical systems behind the primary batteries at LITRONIK are based on Lithium-Iodine (Li-I), Lithium-Manganese Dioxide (Li-MnO2) and Lithium-Carbon Monofluoride (Li-CFx), and they cover three performance ranges for different active implants:
- High Energy Batteries with Li-I technology for implantable pulse generators, e.g. pacemakers or neurostimulators
- Medium Rate Batteries with Li-MnO2 or Li-CFx technology for implants that require mid-range pulse power, e.g. pacemakers, neurostimulators or monitors with telemetry functions
- High Power Batteries with Li-MnO2 technology for implants that require the highest pulse power, e.g. defibrillators
The batteries are manufactured in special dry conditions with a high level of automation. All processes are MES integrated. Materials and processes are 100 percent traceable.
LITRONIK uses its extensive expertise in electrochemistry, materials science, powder processing, metals/plastics technology, plasma and laser welding as well as various chemical and physical analytical processes in order to continually develop more compact and more powerful batteries and thus to enable ever more miniaturised implants.
LITRONIK is certified according to EN ISO 13485:2016. Every employee is fully aware of the high standards of quality required for life-sustaining implants.
Located in Pirna, Germany, roughly 20 km southeast of Dresden, LITRONIK has five production facilities with a total floor space of 5600 m2. The firm currently has approximately 350 employees.
Foundation | 1990 |
Headquarters | Pirna / Germany |
Business premises | 5600 m2 including 4 dry rooms |
Employees | 350 |
Products | Primary batteries for active, medical implants |
Main export markets | Europe, USA, Asia-Pacific |
Management | Dr. Jens Werner, Roland Staub, Michael Bretschneider, Thomas Kutter, Dr. Jens Müller, Dr. Sofiane Bouazza |
Quality standards | DIN EN ISO 13485:2016 (initial certification in 2017, prior to that ISO 9001 certified) |
Memberships | IMAPS, MEPTEC, SMTA, |
Engeneering
LITRONIK’s core areas of expertise for developing and manufacturing standard product lines and customized solutions include:
- Calculation and dimensioning of batteries according to the requirements of an application
- Electrochemistry
- Material science
- Chemical and physical analysis:
- ICP-OES (inductively coupled plasma optical emission spectrometry)
- IR-spectroscopy
- Gas chromatography
- Laser diffraction spectroscopy
- Carl-Fischer analysis
- BET-surface determination
- Micro calorimetry - Chemical synthesis of cathode material
- Powder processing technology including milling, separation, drying and heat treatment
- Metal and plastics engineering
- Laser and plasma welding
- Chemical and process engineering
- Production technology under ultra-dry conditions
- Test systems for electrical characterisation and reliability testing
Quality
LITRONIK’s quality management derives from the requirements of life sustaining medical implants. Its integrated and process-oriented system assures the highest reliability of the batteries and 100% traceability of processes and materials.
Every employee's activities are highly focused on customer requirements plus the quality and reliability of all products and services. Continual improvement of all processes, ongoing training and further education as well as the careful and efficient use of all resources are further cornerstones of the uncompromising quality policy of LITRONIK.
LITRONIK power sources provide today’s state-of-the-art in battery technology for implantable medical devices. The batteries are manufactured within a tightly controlled atmosphere to ensure highly reproducible electrical characteristics.
A completely laser welded stainless steel or titanium case and a high-precision metal-to-glass feedthrough guarantee hermeticity and safe operation.
Key characteristics of LITRONIK batteries include:
- Very high volumetric energy and power densities
- Rate-optimised (µA, mA, A)
- Maximum reliability
- Long lifetime
- Low self-discharge
- Highly reproducible electrical characteristics
- Hermetically sealed stainless steel or Titanium housing with glass-to-metal feedthrough
- 100% electrically, mechanically and visually inspected
- 100% traceability of all processes and materials